Regulating Emotions and Behaviors After Brain Injury
- Conditions
- Acquired Brain InjuryBrain Tumor (After Recovery)EncephalitisMeningitisCerebral AnoxiaStroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)
- Interventions
- Behavioral: Dialectical Behavior Therapy and Radically Open dialectical behavior therapy
- Registration Number
- NCT05393492
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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 :
1. 3 stages, monocentric, comparative, open-label for part of the outcome measures and single-blinded (only for linguistic markers) with active control treatment
2. 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.
3. 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GREMO patients Dialectical Behavior Therapy and Radically Open dialectical behavior therapy 1. 5 months of baseline : usual care of in a medico-social service (medical, social, neuropsychological and psychological), 2. 5 months of dialectical behavior therapy (DBT) -DBT skills training group : during 19 weeks 3. 5 months of follow-up : usual care of + monthly reminders of DBT intervention skills
- Primary Outcome Measures
Name Time Method Quality Of Life after Brain Injury 15 months 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
Name Time Method Evaluation of self-esteem 15 months 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 patientsEvaluation of reflective functioning 15 months 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 RFQEvaluation of psychological distress 15 months 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, 1Evaluation of positive outcomes reported by persons who have experienced traumatic event 15 months 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 executive functioning 15 months 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 functionsEvaluation of the perception of the family functioning 15 months 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 the difficulties in emotions regulation 15 months 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 regulationEvaluation of coping cope with dysfunctions related to their relatives' pathology. 15 months 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 15 months 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 burdenEvaluation of the goal attainment related to better emotional regulation 15 months 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
Trial Locations
- Locations (1)
Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
🇫🇷Illkirch-Graffenstaden, France