Acquired Brain InjuryGREMO-LCANCT05393492
Regulating Emotions and Behaviors After Brain Injury
A study testing Dialectical Behavior Therapy and Radically Open dialectical behavior therapy in people with Acquired Brain Injury and Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), Brain Tumor (After Recovery)
- What is being tested?
- Dialectical Behavior Therapy and Radically Open dialectical behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Being affiliated to a social security
- Fluent in French
- Being able to understand goals and risks and to give a dated and signed consent
- Being 18 years old or more
- Without brain injury
- 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
- 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
Who cannot join
- 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
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- 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
- 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
- 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
- Aphasia or dysarthria not allowing understandable recording
- Impossibility to understand oral questions
- Non fluent in French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
Illkirch-Graffenstaden, 67402
Agata KRASNY-PACINI, +33 3 69 06 30 42, agata.krasny-pacini@ugecam.assurance-maladie.fr
Agata KRASNY-PACINI
About this study
Official title: Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study
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
Read more
- 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.
Read the 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)
- Conditions
- Acquired Brain Injury, Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), Brain Tumor (After Recovery), Encephalitis, Cerebral Anoxia, Meningitis
- Being tested
- Dialectical Behavior Therapy and Radically Open dialectical behavior therapy
- 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
- Medical subject headings
- Brain Injuries, Stroke, Ischemia, Brain Neoplasms, Encephalitis, Hypoxia, Brain, Meningitis, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy and Radically Open dialectical behavior therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GREMO patients | Experimental | 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 Receives: Behavioral: Dialectical Behavior Therapy and Radically Open dialectical behavior therapy |
| Controls without brain injury | No intervention | People without brain injury used as controls for linguistic markers of emotional expression regulation and free will. |
| GREMO patients' family | No intervention | 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 |
| Qualitative research ABI patients and families | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (10)
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
Measured: 15 months
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
Measured: 15 months
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
Measured: 15 months
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
Measured: 15 months
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
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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
Measured: 15 months
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start19 May 2022
- Primary completion19 May 2022
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- DBT for patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393492
- Sponsor's protocol ID
- 8264
- Acronym
- GREMO-LCA
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study
- ClinicalTrials.gov ID
- NCT05393492
- Acronym / sponsor ID
- GREMO-LCA / 8264
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- DBT for patients
| Arm | Type | Receives |
|---|---|---|
| GREMO patients | Experimental | Behavioral: Dialectical Behavior Therapy and Radically Open dialectical behavior therapy1. 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 |
| Controls without brain injury | No intervention | –People without brain injury used as controls for linguistic markers of emotional expression regulation and free will. |
| GREMO patients' family | No intervention | –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 |
| Qualitative research ABI patients and families | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
Key exclusion criteria (27 listed)
- Controls without brain injury
- GREMO patients' family members
- Qualitative research ABI patients and families
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior Therapy and Radically Open dialectical behavior therapyDialectical 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. | Behavioural | GREMO patients |
Primary outcome
Quality Of Life after Brain Injury
Time frame: 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.
10 secondary outcomes
Evaluation of the difficulties in emotions regulation
Time frame: 15 months
Evaluation of self-esteem
Time frame: 15 months
Evaluation of executive functioning
Time frame: 15 months
Evaluation of reflective functioning
Time frame: 15 months
Evaluation of psychological distress
Time frame: 15 months
Evaluation of positive outcomes reported by persons who have experienced traumatic event
Time frame: 15 months
Evaluation of the perception of the family functioning
Time frame: 15 months
Evaluation of coping cope with dysfunctions related to their relatives' pathology.
Time frame: 15 months
Evaluation of family burden
Time frame: 15 months
Evaluation of the goal attainment related to better emotional regulation
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acquired Brain Injury
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RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
Illkirch-Graffenstaden, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy and Radically Open dialectical behavior therapy in people with Acquired Brain Injury and Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic), run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life after Brain Injury (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.