Regulating Emotions and Behaviors After Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dialectical Behavior Therapy and Radically Open dialectical behavior therapy

    Behavioral

    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.

Treatment groups

77 Participants
are divided into 4 treatment groups
Group A: GREMO patientsExperimental treatment 1 intervention
Group B: Controls without brain injuryNo intervention 0 interventions
Group C: GREMO patients' familyNo intervention 0 interventions
Group D: Qualitative research ABI patients and familiesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
15 months

Secondary outcomes

1

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

Time frame
15 months
2

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

Time frame
15 months
3

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

Time frame
15 months
4

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

Time frame
15 months

Other outcomes

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