NCT05393492Recruiting
Regulating Emotions and Behaviors After Brain Injury
Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- First submitted
- 18 Jan 2022
- Start date
- 19 May 2022
- Primary completion date
- 19 May 2022
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Stroke
- NCT number
- NCT05393492
What you commit to
- Study type: Interventional
- Planned participants: 77
- From 19 May 2022 to the primary completion date, 19 May 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC) Coordinator of this site? Confirm its status | Illkirch-Graffenstaden | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.