Back to resultsEmotion Regulation Group Study (EmoReg)
Primary Purpose
Emotional Dysfunction, Borderline Personality Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Emotion regulation group
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Dysfunction
Eligibility Criteria
Inclusion Criteria: Aged between 16 to 20 years old. > 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability French speaking Availability during the whole study Willingness in participating to the intervention and the research Informed consent read and signed Exclusion Criteria: Current hospitalization Psychotic disorder Severe and persistent substance addiction Antisocial personality disorder Inability to participate in group sessions Current pregnancy Non-French speaking Previous enrolment into the current study
Sites / Locations
- Hôpitaux Universitaires de Genève (HUG)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
psychotherapeutic intervention with class risk A (low risk, no invasive procedure)
Arm Description
an eight-week emotion regulation group intervention
Outcomes
Primary Outcome Measures
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Informant-report measure of emotion dysregulation
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Informant-report measure of emotion dysregulation
Secondary Outcome Measures
Changes from Baseline in Beck Depression Inventory (BDI-II)
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
Changes from Baseline in Beck Depression Inventory (BDI-II)
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
Changes from Baseline in self-report Family Attitude Scale (FAS)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Changes from Baseline in self-report Family Attitude Scale (FAS)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Changes from Baseline in parent-report Family Attitude Scale (FAS)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Changes from Baseline in parent-report Family Attitude Scale (FAS)
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Changes from Baseline in Borderline Symptom List (BSL-23)
Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges
Changes from Baseline in Borderline Symptom List (BSL-23)
Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
Full Information
NCT ID
NCT05734677
First Posted
January 11, 2023
Last Updated
February 8, 2023
Sponsor
Camille Nemitz Piguet
Collaborators
Fondation Privée des HUG
1. Study Identification
Unique Protocol Identification Number
NCT05734677
Brief Title
Emotion Regulation Group Study
Acronym
EmoReg
Official Title
Emotion Regulation Group Intervention for Late Adolescents: a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 6, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Camille Nemitz Piguet
Collaborators
Fondation Privée des HUG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Dysfunction, Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
psychotherapeutic intervention with class risk A (low risk, no invasive procedure)
Arm Type
Experimental
Arm Description
an eight-week emotion regulation group intervention
Intervention Type
Behavioral
Intervention Name(s)
Emotion regulation group
Intervention Description
90 minute sessions once a week for 8 weeks, in groups of eight participants. DBT, MBT and MBI inspired, psychoeducative intervention.
Primary Outcome Measure Information:
Title
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
Description
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Difficulties in emotion regulation scale (DERS)
Description
36 items self-report scale: Higher scores suggest greater problems with emotion regulation.
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Description
Informant-report measure of emotion dysregulation
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Emotion Dysregulation Inventory (EDI)
Description
Informant-report measure of emotion dysregulation
Time Frame
V3 (3 months after the intervention)
Secondary Outcome Measure Information:
Title
Changes from Baseline in Beck Depression Inventory (BDI-II)
Description
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Beck Depression Inventory (BDI-II)
Description
Self-report inventory scored from 0 to 63 (higher score = more severe depressive symptoms)
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
Description
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in State-Trait Anxiety Inventory (STAI)
Description
40 self-report items on a 4-point Likert scale: higher scores = greater anxiety
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in self-report Family Attitude Scale (FAS)
Description
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in self-report Family Attitude Scale (FAS)
Description
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in parent-report Family Attitude Scale (FAS)
Description
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in parent-report Family Attitude Scale (FAS)
Description
30-item, Likert-scaled assessment for measuring the emotional climate of families (higher score = more critical family environment)
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in Borderline Symptom List (BSL-23)
Description
Self-rating tool for Borderline Personality Disorder (BPD) symptoms: higher scores = more likely to have BPD and associated challenges
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Borderline Symptom List (BSL-23)
Description
Self-rating tool for BPD symptoms: higher scores = more likely to have BPD and associated challenges
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
Description
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in self-report Strength & Difficulties Questionnaire (SDQ)
Description
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
Description
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in parent-report Strength & Difficulties Questionnaire (SDQ)
Description
brief emotional and behavioural screening questionnaire assessing 25 attributes, some positive and others negative.
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Description
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Cognitive Emotion Regulation Questionnaire (CERQ)
Description
Self-report measure designed to assess individual differences in cognitive regulation of emotions in response to stressful events. subscale scores can range from 4 to 20 with higher subscale scores indicating greater frequency of use of the specific cognitive strategy.
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
Description
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Kentucky inventory of mindfulness skills (KIMS)
Description
self-report measuring Mindfulness on four scales: Observing, Describing, Act With Awareness, and Accept Without Judgment. Higher scores = higher mindfulness
Time Frame
V3 (3 months after the intervention)
Title
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Description
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
Time Frame
V2 (within two weeks after the end of the intervention)
Title
Changes from Baseline in Perceived Parental Autonomy Support Scale (P-PASS)
Description
Measures parental autonomy-support and control of late adolescents and emerging adults. 24 items, assessed on a 7 point Likert scale.
Time Frame
V3 (3 months after the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged between 16 to 20 years old.
> 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability
French speaking
Availability during the whole study
Willingness in participating to the intervention and the research
Informed consent read and signed
Exclusion Criteria:
Current hospitalization
Psychotic disorder
Severe and persistent substance addiction
Antisocial personality disorder
Inability to participate in group sessions
Current pregnancy
Non-French speaking
Previous enrolment into the current study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Piguet
Phone
+41 79 668 75 07
Email
camille.piguet@unige.ch
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève (HUG)
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Perroud, Pr
Email
Nader.Perroud@hcuge.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Emotion Regulation Group Study
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