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DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder (DIABOLO)

Primary Purpose

Female, Borderline Personality Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DBT+ACT
DBT
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Female focused on measuring Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Prevention, Dialectic Behavioral Therapy, Acceptance Commitment Therapy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Being a woman
  • Between 18 and 50 years old
  • Clinical diagnosis of BPD using the Structured Clinical Interview for DSM-IV-TR ( Diagnostic and Statistical Manual of mental disorders) Axis II Personality Disorders)
  • Having signed the informed consent
  • Able to realize all the visits and therapy sessions
  • Able to speak, read and understand French

Exclusion Criteria:

  • Life time diagnosis of schizophrenia
  • Life time diagnosis of intellectual disability
  • Not able to read and write
  • Refusal of participation
  • Subject protected by law (guardianship)
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Not belonging to social safety system
  • Exclusion period in relation to another protocol

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

DBT + ACT group

DBT group

Arm Description

- The experimental group (DBT+ ACT) led in Montpellier during 6 months.

The control group (DBT) led in Geneva during 12 months.

Outcomes

Primary Outcome Measures

Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up
Evaluation and comparison of suicide attempts number before and after therapy between DBT and DBT+ACT groups with the Columbia-Suicide severity rating scale : indication of the number of proven suicide attempts and score from 0 to 5 depending on the severity of the suicide attempt

Secondary Outcome Measures

Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the has to choose a score from 0 to 4 (from not at all to very strongly)
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of has to choose a score from 0 to 3 (from almost never to almost always)
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Hopelessness using the Beck Hopelessness Scale (BHS)
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false
Hopelessness using the Beck Hopelessness Scale (BHS)
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false
Hopelessness using the Beck Hopelessness Scale (BHS)
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false.
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Meaning in life assessment using Life Regard Index (LRI)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Meaning in life assessment using Life Regard Index (LRI)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Meaning in life assessment using Life Regard Index (LRI)
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Satisfaction of the intervention using the Likert scales rating from 0 (not at all satisfied) to 10 (extremely satisfied)
Evaluation of the satisfaction about the intervention within the two groups (DBT versus DBT+ACT)
Quality of life related to health using the EQ5D-3L questionnaire
Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.
Quality of life related to health using the EQ5D-3L questionnaire
Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Global functioning using the Global Assessment of Functioning Scale (GAF)
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Global functioning using the Global Assessment of Functioning Scale (GAF)
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Global functioning using the Global Assessment of Functioning Scale (GAF)
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Incremental cost-effectiveness ratio (ICER)
Evaluation and comparison of the incremental cost-effectiveness ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)
Incremental cost-utility ratio (ICUR)
Evaluation and comparison of the incremental cost-utility ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)

Full Information

First Posted
March 14, 2019
Last Updated
March 9, 2020
Sponsor
University Hospital, Montpellier
Collaborators
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03880071
Brief Title
DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder
Acronym
DIABOLO
Official Title
Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Abandoned study
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority. Borderline personality disorder (BPD) is a common condition affecting 6% of the population. This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment. BPD is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a BPD. Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt. People with a BPD are highly sensitive to it. Unfortunately, patient care for this disorder is limited. Pharmacological strategies didn't show any efficacy and psychotherapies, although proven effective, are difficult to set up. As BPD is strongly related to suicidal attempts it appears to be a good model to study suicidal behavior. Thus, this study could improve knowledge in this field. Suicidal behavior in patients receiving the standard therapy (dialectic behavioural therapy: DBT) will be compared to patients receiving dialectical behavior therapy and acceptance commitment therapy (ACT). Clinical data reflecting how the participant is feeling will be collected as well.
Detailed Description
An emotional dysregulation has been linked to suicidal behavior in patients with BPD. Up to this date, no program had combined dialectical behavior therapy with acceptance commitment therapy. DBT aims to teach skills in four different fields : mindfulness, emotional regulation, distress tolerance and interpersonal efficiency. ACT helps to develop metacognitive skills and to identify what makes sense in one's life. Because 75% of BPD patients are women, the study will only focus on them. Patients will be evaluated during 4 visits : Inclusion : 1 or 2 weeks before the first session of therapy. During this visit patients will undergo a clinical exam and will complete questionnaires. First follow-up visit : 6 months after the first session (for the experimental group) or 12 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, therapy satisfaction and cost- effectiveness ratio will be evaluated Second follow-up visit : 12 months after the first sessions (for the experimental group) or 18 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, and cost- effectiveness ratio will be evaluated Third follow-up visit : 18 months after the first session (for the experimental group) or 24 months after the first session (for the control group). During this visit will undergo a clinical exam and will complete questionnaires. Therapeutic processes, and cost- effectiveness ratio will be evaluated The hypothesis is that DBT+ ACT allows reducing suicidal recidivism, reducing economical cost linked to BPD and improving quality of life and functioning among patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female, Borderline Personality Disorder
Keywords
Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Prevention, Dialectic Behavioral Therapy, Acceptance Commitment Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBT + ACT group
Arm Type
Experimental
Arm Description
- The experimental group (DBT+ ACT) led in Montpellier during 6 months.
Arm Title
DBT group
Arm Type
Other
Arm Description
The control group (DBT) led in Geneva during 12 months.
Intervention Type
Behavioral
Intervention Name(s)
DBT+ACT
Intervention Description
- The experimental group (DBT+ ACT) will have: 25 therapy group sessions (1 sessions of 2 hours once a week) 25 individual interview sessions (1 sessions of 1 hour once a week) will receive 25 group sessions and 25 individual ones during 6 months.
Intervention Type
Behavioral
Intervention Name(s)
DBT
Intervention Description
The control group (DBT) will have: 50 therapy group sessions (1 session of 2h30 once a week) 50 individual interview sessions (1 sessions of 1 hour once a week)
Primary Outcome Measure Information:
Title
Number of proven suicide attempts using the Columbia-Suicide severity rating scale (C-SSRS) at 1 year follow-up
Description
Evaluation and comparison of suicide attempts number before and after therapy between DBT and DBT+ACT groups with the Columbia-Suicide severity rating scale : indication of the number of proven suicide attempts and score from 0 to 5 depending on the severity of the suicide attempt
Time Frame
At 1 year after the intervention
Secondary Outcome Measure Information:
Title
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At one week after the intervention
Title
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At 6 months after the intervention
Title
Evolution of para- suicidal symptomatology using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Evaluation and comparison of para -suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 17 close-ended questions of the Columbia-Suicide severity rating scale
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximum possible suicidal ideation)
Description
Evaluation and comparison of suicidal symptomatology between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of suicidal intent)
Description
Evaluation and comparison of intensity of suicidal intent between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal intensity of imperious need for non-suicidal self-damaging behavior)
Description
Evaluation and comparison of intensity of imperious need for non-suicidal self-damaging behavior between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal quality of perceived social support)
Description
Evaluation and comparison of quality of perceived social support between pre-intervention and post-intervention (one week after the last session of the intervention)within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (none) to 10 (maximal psychological pain)
Description
Evaluation and comparison of psychological pain between pre-intervention and post-intervention (one week after of the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 6 months after the intervention
Title
Evolution of para-suicidal symptomatology (Likert scales from 0 (not all characteristic of my way of being) to 10 (completely characteristic of my way of being)
Description
Evaluation and comparison of the evolution of intensity of each constituent trait of borderline personality disorder between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)
Time Frame
At 12 months after the intervention
Title
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Description
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)
Time Frame
At one week after the intervention
Title
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Description
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the has to choose a score from 0 to 4 (from not at all to very strongly)
Time Frame
At 6 months after the intervention
Title
Evolution of the borderline symptomatology using the Borderline Symptom List-23 (BSL-23) scale
Description
Evaluation and comparison of the evolution of the borderline symptomatology between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 24 items of the Borderline Symptom List-23 (BSL-23) scale. For every question, the subject has to choose a score from 0 to 4 (from not at all to very strongly)
Time Frame
At 12 months after the intervention
Title
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Description
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Time Frame
At one week after the intervention
Title
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Description
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Time Frame
At 6 months after the intervention
Title
Evolution of emotional regulation abilities using the Difficulties in Emotion Regulation Scale (DERS)
Description
Evaluation and comparison of the evolution of emotional regulation abilities between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 36 items of the Difficulties in Emotion Regulation Scale. For every question, the subject has to choose a score from 1 to 5 (from almost never to almost always)
Time Frame
At 12 months after the intervention
Title
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Description
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Time Frame
At one week after the intervention
Title
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Description
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Time Frame
At 6 months after the intervention
Title
Evolution of propensity to dissociation using the Dissociative Experience Scale (DES)
Description
Evaluation and comparison of the propensity to dissociation between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Dissociative Experience Scale. For every question, the subject has to choose a score from 0% to 100%.
Time Frame
At 12 months after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)
Time Frame
At one week after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of has to choose a score from 0 to 3 (from almost never to almost always)
Time Frame
At 6 months after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-Trait)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-Trait). For every question, the subject has to choose a score from 0 to 3 (from almost never to almost always)
Time Frame
At 12 months after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT)with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Time Frame
At one week after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Time Frame
At 6 months after the intervention
Title
Anxiety state using the State-Trait Anxiety Inventory (STAI-State)
Description
Evaluation and comparison of the state of anxiety between pre-intervention and post-intervention (one week after the last session of the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the State-Trait Anxiety Inventory (STAI-State). For every question, the subject has to choose a score from 0 to 3 (from no to yes)
Time Frame
At 12 months after the intervention
Title
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
Description
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)
Time Frame
At 6 months after the intervention
Title
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT)
Description
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 33 items of Spielberger State-Trait Anger Expression Inventory (STAXI-TRAIT). For every question, the subject has to choose a score from 1 to 4 (from almost never to almost always)
Time Frame
At 12 months after the intervention
Title
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Description
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Time Frame
At one week after the intervention
Title
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Description
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Time Frame
At 6 months after the intervention
Title
Anger state using the Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT)
Description
Evaluation and comparison of the state of anger between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 10 items of Spielberger State-Trait Anger Expression Inventory (STAXI-ETAT). For every question, the subject has to choose a score from 1 to 4 (from not at all to a lot)
Time Frame
At 12 months after the intervention
Title
Hopelessness using the Beck Hopelessness Scale (BHS)
Description
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false
Time Frame
At one week after the intervention
Title
Hopelessness using the Beck Hopelessness Scale (BHS)
Description
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false
Time Frame
At 6 months after the intervention
Title
Hopelessness using the Beck Hopelessness Scale (BHS)
Description
Evaluation and comparison of the hopelessness between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the Beck Hopelessness Scale. For every question, the subject has to answer true or false.
Time Frame
At 12 months after the intervention
Title
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Description
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Time Frame
At one week after the intervention
Title
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Description
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Time Frame
At 6 months after the intervention
Title
Quality Of Life evaluated by the World Health Organization Quality of Life measure (WHOQOL-BREF)
Description
Evaluation and comparison of the quality of life between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 20 items of the World Health Organization Quality of Life measure (WHOQOL-BREF). For every question, the subject has to choose a score from 1 to 5.
Time Frame
At 12 months after the intervention
Title
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Description
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Time Frame
At one week after the intervention
Title
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Description
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Time Frame
At 6 months after the intervention
Title
Acceptance assessment using the Acceptance and Action Questionnaire (AAQII)
Description
Evaluation and comparison of the acceptance between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 10 items of the Acceptance and Action Questionnaire (AAQII)). For every question, the subject has to choose a score from 1 to 7(never true to always true).
Time Frame
At 12 months after the intervention
Title
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Time Frame
At one week after the intervention
Title
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Time Frame
At 6 months after the intervention
Title
Contact with the present moment assessment using the Mindful Attention Awareness Scale (MAAS)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 15 items of Mindful Attention Awareness Scale (MAAS). For every question, the subject has to choose a score from 1 to 6 (almost always to almost never).
Time Frame
At 12 months after the intervention
Title
Meaning in life assessment using Life Regard Index (LRI)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Time Frame
At one week after the intervention
Title
Meaning in life assessment using Life Regard Index (LRI)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Time Frame
At 6 months after the intervention
Title
Meaning in life assessment using Life Regard Index (LRI)
Description
Evaluation and comparison of the contact with the present moment between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the 28 items of the Life Regard Index (LRI)). For every question, the subject has to answer agree, neutral or ont agree
Time Frame
At 12 months after the intervention
Title
Satisfaction of the intervention using the Likert scales rating from 0 (not at all satisfied) to 10 (extremely satisfied)
Description
Evaluation of the satisfaction about the intervention within the two groups (DBT versus DBT+ACT)
Time Frame
At one week after the intervention
Title
Quality of life related to health using the EQ5D-3L questionnaire
Description
Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.
Time Frame
At 6 months after the intervention
Title
Quality of life related to health using the EQ5D-3L questionnaire
Description
Evaluation and comparison of the quality of life between pre-intervention and 6 months post-intervention within the two groups (DBT versus DBT+ACT) with the 5 items of the EQ5D-3L. For every question, the subject has the choice between 3 answers.
Time Frame
At 12 months after the intervention
Title
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Description
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Time Frame
At one week after the intervention
Title
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Description
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Time Frame
At 6 months after the intervention
Title
Depression intensity using the Inventory of Depressive Symptomatology (IDS-C30)
Description
Evaluation and comparison of the intensity of depression between pre-intervention and post-intervention (one week after the last session) within the two groups (DBT versus DBT+ACT) with the 30 items of Inventory of Depressive Symptomatology (IDS-C30). For every item corresponding to a depressive symptom, the investigator has the choice between 3 levels of response.
Time Frame
At 12 months after the intervention
Title
Global functioning using the Global Assessment of Functioning Scale (GAF)
Description
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Time Frame
At one week after the intervention
Title
Global functioning using the Global Assessment of Functioning Scale (GAF)
Description
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Time Frame
At 6 months after the intervention
Title
Global functioning using the Global Assessment of Functioning Scale (GAF)
Description
Evaluation and comparison of the global functioning between pre-intervention and post-intervention (one week after the intervention) within the two groups (DBT versus DBT+ACT) with the Global Assessment of Functioning Scale (GAF).With this scale, the investigator has to give a score between 0 to 100 for the global functioning of the patient
Time Frame
At 12 months after the intervention
Title
Incremental cost-effectiveness ratio (ICER)
Description
Evaluation and comparison of the incremental cost-effectiveness ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)
Time Frame
At 1 year follow-up
Title
Incremental cost-utility ratio (ICUR)
Description
Evaluation and comparison of the incremental cost-utility ratio between pre-intervention and 12 months post-intervention within the two groups (DBT versus DBT+ACT)
Time Frame
At 1 year follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a woman Between 18 and 50 years old Clinical diagnosis of BPD using the Structured Clinical Interview for DSM-IV-TR ( Diagnostic and Statistical Manual of mental disorders) Axis II Personality Disorders) Having signed the informed consent Able to realize all the visits and therapy sessions Able to speak, read and understand French Exclusion Criteria: Life time diagnosis of schizophrenia Life time diagnosis of intellectual disability Not able to read and write Refusal of participation Subject protected by law (guardianship) Deprived of liberty Subject (by judicial or administrative decision) Not belonging to social safety system Exclusion period in relation to another protocol
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

DIalectical Behavior Therapy and Acceptance Commitment Therapy Short Program for BOrderLine persOnality Disorder

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