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Regulating Emotions and Behaviors After Brain Injury (GREMO-LCA)

Primary Purpose

Acquired Brain Injury, Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), Brain Tumor (After Recovery)

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Dialectical Behavior Therapy and Radically Open dialectical behavior therapy

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring brain injury, dialectical behavior therapy, emotions, emotional dysregulation, behavioral disorders, spirituality, challenging behaviors, linguistic markers, emotional distress, family burden, free will, interpretative phenomenological analysis, single-case experimental design

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligibility Criteria: * (Limit: 15,000 characters)

Summary criteria for participant selection.

Main eligibility criteria

GREMO patients :

Inclusion criteria:
- Persons with acquired brain injury regardless of the type or location of the injury
- Age between 18 and 68
- Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury)
- Challenging behaviors or emotional dysregulation or high level of anxiety / depression or family's complaints about emotional dysregulation
- Secondary or exacerbated by an acquired brain injury
- Causing important suffering for themselves or their families
- Being affiliated to a social security
- Fluent in French
- Being able to understand goals and risks and to give a dated and signed consent
Exclusion criteria:
- Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia
- Patients without any complaints
- Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions
- Non fluent in French
- Associated brain degenerative disease
- Cancerous brain injury with uncertain progression
- Non-stabilized psychotic disorder
- Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy)

Controls without brain injury

Inclusion criteria :
- Being 18 years old or more
- Without brain injury
Exclusion criteria :
- Non fluent in French
- History of brain injury or brain disease
- History of psychiatric disorder
- Personality disorder
- GREMO patient's family member living together
- Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession
- Being under guardianship or curatorship
- Being pregnant or breastfeeding

GREMO patients' family members

Inclusion criteria :
- Being 18 years old or more
- GREMO patient's family member
- Living with a GREMO patient
- Agreeing to rate an emotion-behavior-skills diary cards
Exclusion criteria :
- GREMO patient's refusal for their family member to participate
- Non fluent in French
- Brain injury or brain disease
- Major lack of insight
- Being under trusteeship or curatorship

Qualitative research ABI patients and families

Inclusion criteria :
- Person with ABI attending the same medico-social service as GREMO patients
- Ineligible for GREMO patients group (participation refusal, major insight difficulty…)
- Agreeing to talk about their free will or spirituality
Exclusion criteria :
- Aphasia or dysarthria not allowing understandable recording
- Impossibility to understand oral questions
- Non fluent in French

Sites / Locations

Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

GREMO patients

Controls without brain injury

GREMO patients' family

Qualitative research ABI patients and families

Arm Description

5 months of baseline : usual care of in a medico-social service (medical, social, neuropsychological and psychological), 5 months of dialectical behavior therapy (DBT) -DBT skills training group : during 19 weeks 5 months of follow-up : usual care of + monthly reminders of DBT intervention skills

People without brain injury used as controls for linguistic markers of emotional expression regulation and free will.

GREMO patients' relatives, without brain injury, living with the GREMO patient and ready to complete every day and adapted self-observational diary card similar to the one of the GREMO patient

Patients and relatives followed by the same medico-social service but not meeting GREMO patients eligibility criteria, participating only in the qualitative research on free will and spirituality

Outcomes

Primary Outcome Measures

Quality Of Life after Brain Injury

Evaluation of quality of life after brain injury with QOLIBRI (Quality Of Life after Brain Injury)on 37 items belonging to 6 factors: cognition, self, daily life and autonomy, social relationships, emotions and physical problems. The Qolibri scores are reported a 0-100. 0 is the worst and 100 is the best. Self-rated by GREMO patients.

Secondary Outcome Measures

Evaluation of the difficulties in emotions regulation

Evaluation of emotional regulation difficulties with DERS ( Difficuties en Emotion Regulation Scale)-16 on 16 items filed in 5 factors : lack of emotional clarity, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to effective emotion regulation strategies, nonacceptance of emotional responses. Self-rated by GREMO patients and self-rated by family member about themselves. DERS-16 can range from 16 to 80, higher scores suggest greater problems with emotion regulation

Evaluation of self-esteem

Evaluation of self-esteem on 10 items with EES-10 (Rosenberg Self-Esteem Scale) . You then get a score between 10 and 40.If you score below 25, your self-esteem is very low. Work in this area seems desirable. If you get a score above 39, your self-esteem is very high and you tend to be strongly assertive. Self-rated by GREMO patients

Evaluation of executive functioning

Evaluation of executive functioning with BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) on 75 items filed in inhibit, self-monitor, plan/organize, shift, initiate, task monitor, emotional control, working memory and organization of materials. Self-rated by GREMO patients and proxi-rated by a family member.high scores obtained on the BRIEF do not indicate a "disorder of executive function" but rather suggest a higher level of dysfunction in a specific domain of executive functions

Evaluation of reflective functioning

Evaluation of reflective functioning with RFQ (Reflective Function Questionnaire) on 8 items. 7 if you strongly agree, and the 1 if you arestrongly disagree. Use the middle point (the 4) if you are neutral or indecisive requirements of the RFQ

Evaluation of psychological distress

Evaluation of psychological distress with DASS-21 (Depression Anxiety Stress Scale) on 21 items about depression, anxiety and stress. Each of the 21 questions is scored on a 4-point scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much, or most of the time"). Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items: Depression: 3, 5, 10, 13, 16, 17, 21 Anxiety: 2, 4, 7, 9, 15, 19, 20 Stress: 1, 6, 8, 11, 12, 14, 1

Evaluation of positive outcomes reported by persons who have experienced traumatic event

Evaluation of positive outcomes reported by persons who have experienced traumatic events, such as brain injury, which evaluates new possibilities, relating to others, personal strength, spiritual change, and appreciation of life with Post-traumatic Growth Inventory. Self-rated by GREMO patients. It consists of 21 questions to which responses are given on a scale of 0-5, with 0 representing no change and 5 showing a great degree of change.

Evaluation of the perception of the family functioning

Evaluation of the perception of the family functioning on 12 items with FAD (Family Assessment Device). Scores range from 1 to 4 with 1 reflecting healthy functioning and 4 reflecting unhealthy functioning.

Evaluation of coping cope with dysfunctions related to their relatives' pathology.

Evaluation of coping cope with dysfunctions related to their relatives' pathology. Rated by a family member with FCQ (Family Coping Questionnaire).It consists of 21 questions to which responses are given on a scale of 0-5, with 0 representing no change and 5 showing a great degree of change.

Evaluation of family burden

Evaluation of family burdenon 21 items with Zarit (Zarit Burden Interview) questionnaire Rated by a family member.The Zarit Burden Interview (ZBI) The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more was considered high burden

Evaluation of the goal attainment related to better emotional regulation

3 milestone, 5-level GAS, evaluating goal attainment related to better emotional regulation. Each GREMO patient will have at least on personalized GAS according to his/her goals with Goal Attainment Scaling. 0 means not important, 1 means important, 2 means very important and 3 means extremely important

Full Information

NCT ID

NCT05393492

First Posted

January 18, 2022

Last Updated

May 23, 2022

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT05393492

Brief Title

Regulating Emotions and Behaviors After Brain Injury

Acronym

GREMO-LCA

Official Title

Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 19, 2022 (Actual)

Primary Completion Date

May 19, 2022 (Actual)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

After acquired brain injury (ABI), persons can experience emotional and behavioral difficulties, that can be painful both for the person and his/her family. This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called "dialectical behavior therapy" (DBT). DBT aims at teaching persons emotion regulation skills, interpersonal effectiveness skills, mindfulness and distress tolerance skills through group and individual sessions. The study's hypothesis is that DBT, in an adapted format for persons with ABI can lead to a better quality of life, emotional and behavioral regulation, and self-esteem decrease in problematic behaviors progress in life goals increase post traumatic growth and spirituality better family functioning and lesser burden for care givers experiencing more emotions and more free will 45 persons with an ABI sustained more than 18 month back, will follow a 3 phases, follow-up with care as usual for 5 months, followed by 5 months of DBT, followed by 5 months of care as usual + DBT monthly sessions. Self- and family-questionnaire will explore quality of life, emotional regulation, self-esteem, stress, anxiety, cognitive difficulties, family functioning and coping, post traumatic growth and spirituality and will be compared across the 3 phases. Results will be analyzed at a group level but also at an individual level (each patient separately) to test for decrease in unwanted behaviors and at a dyadic level (the person and his/her spouse) to test for the mutual effect of regulating emotions. Persons' memories will by analyzed at 3 time points by a linguistic analysis, and experience of free will after ABI will be analyzed by transcribed narratives of participants.

Detailed Description

The study will explore the impact of Dialectical Behavior Therapy (DBT) skills training on patients with ABI, their families and on for their family system interactions. ->Triple methodology : 3 stages, monocentric, comparative, open-label for part of the outcome measures and single-blinded (only for linguistic markers) with active control treatment Prospective (at the individual level) and correlational (at the dyad level: client - family member) single-case experimental study exploring emotional-behavioral interactions as a function of the use of DBT skills by the client, over time. Further, it will explore the experience of free will (the property of the human will to determine itself freely), in relation to emotions and meaning of life/spirituality after ABI and the modifications of this experience after DBT. qualitative study of semi-structured individual by Interpretative Phenomenological Analysis (IPA The objectives of this research are to show that a group training of DBT skills allows persons with ABI, (1) to improve quality of life - main objective; (2) to improve self-esteem and emotional regulation (3) to decrease depressive symptoms and problematic behaviors, (4) to self-determine and achieve one's goals (Goal Attainment Scaling) for a life worth living; (5) to improve coping and family functioning; (7) to decrease caregiver burden; (8) to interpret one's life, with more expression of emotions, non-judgment, acceptance of the difficulty of life and motivation to change (measured by linguistic analysis of emotionally charged memories)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Brain Injury, Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), Brain Tumor (After Recovery), Encephalitis, Cerebral Anoxia, Meningitis

Keywords

brain injury, dialectical behavior therapy, emotions, emotional dysregulation, behavioral disorders, spirituality, challenging behaviors, linguistic markers, emotional distress, family burden, free will, interpretative phenomenological analysis, single-case experimental design

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

DBT for patients

Masking

Outcomes Assessor

Masking Description

Blinded analysis of linguistic markers of emotional regulation and free will by an independent laboratory

Allocation

Non-Randomized

Enrollment

77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GREMO patients

Arm Type

Experimental

Arm Description

Arm Title

Controls without brain injury

Arm Type

No Intervention

Arm Description

People without brain injury used as controls for linguistic markers of emotional expression regulation and free will.

Arm Title

GREMO patients' family

Arm Type

No Intervention

Arm Description

GREMO patients' relatives, without brain injury, living with the GREMO patient and ready to complete every day and adapted self-observational diary card similar to the one of the GREMO patient

Arm Title

Qualitative research ABI patients and families

Arm Type

No Intervention

Arm Description

Patients and relatives followed by the same medico-social service but not meeting GREMO patients eligibility criteria, participating only in the qualitative research on free will and spirituality

Intervention Type

Behavioral

Intervention Name(s)

Dialectical Behavior Therapy and Radically Open dialectical behavior therapy

Intervention Description

Dialectical Behavior Therapy is a third wave cognitive-behavioral therapy. It focuses on emotional dysregulation and interactions between the patient and his family in genesis and maintenance of challenging behaviors. It is used here in an adapted form for cognitive problems. Delivered in a group format of 19 weeks + individual sessions.

Primary Outcome Measure Information:

Title

Quality Of Life after Brain Injury

Description

Time Frame

15 months

Secondary Outcome Measure Information:

Title

Evaluation of the difficulties in emotions regulation

Description

Time Frame

15 months

Title

Evaluation of self-esteem

Description

Time Frame

15 months

Title

Evaluation of executive functioning

Description

Time Frame

15 months

Title

Evaluation of reflective functioning

Description

Time Frame

15 months

Title

Evaluation of psychological distress

Description

Time Frame

15 months

Title

Evaluation of positive outcomes reported by persons who have experienced traumatic event

Description

Time Frame

15 months

Title

Evaluation of the perception of the family functioning

Description

Time Frame

15 months

Title

Evaluation of coping cope with dysfunctions related to their relatives' pathology.

Description

Time Frame

15 months

Title

Evaluation of family burden

Description

Time Frame

15 months

Title

Evaluation of the goal attainment related to better emotional regulation

Description

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: * (Limit: 15,000 characters) Summary criteria for participant selection. Main eligibility criteria GREMO patients : Inclusion criteria: Persons with acquired brain injury regardless of the type or location of the injury Age between 18 and 68 Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury) Challenging behaviors or emotional dysregulation or high level of anxiety / depression or family's complaints about emotional dysregulation Secondary or exacerbated by an acquired brain injury Causing important suffering for themselves or their families Being affiliated to a social security Fluent in French Being able to understand goals and risks and to give a dated and signed consent Exclusion criteria: Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia Patients without any complaints Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions Non fluent in French Associated brain degenerative disease Cancerous brain injury with uncertain progression Non-stabilized psychotic disorder Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy) Controls without brain injury Inclusion criteria : Being 18 years old or more Without brain injury Exclusion criteria : Non fluent in French History of brain injury or brain disease History of psychiatric disorder Personality disorder GREMO patient's family member living together Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession Being under guardianship or curatorship Being pregnant or breastfeeding GREMO patients' family members Inclusion criteria : Being 18 years old or more GREMO patient's family member Living with a GREMO patient Agreeing to rate an emotion-behavior-skills diary cards Exclusion criteria : GREMO patient's refusal for their family member to participate Non fluent in French Brain injury or brain disease Major lack of insight Being under trusteeship or curatorship Qualitative research ABI patients and families Inclusion criteria : Person with ABI attending the same medico-social service as GREMO patients Ineligible for GREMO patients group (participation refusal, major insight difficulty…) Agreeing to talk about their free will or spirituality Exclusion criteria : Aphasia or dysarthria not allowing understandable recording Impossibility to understand oral questions Non fluent in French

Facility Information:

Facility Name

Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)

City

Illkirch-Graffenstaden

ZIP/Postal Code

67402

Country

France

Individual Site Status

Recruiting

Facility Contact: