Regulating Emotions and Behaviors After Brain Injury

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05393492
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Strasbourg, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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)

Arms & Interventions

Arms

Experimental: GREMO patients

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

No Intervention: Controls without brain injury

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

No Intervention: GREMO patients' family

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

No Intervention: Qualitative research ABI patients and families

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

Interventions

Behavioral: - Dialectical Behavior Therapy and Radically Open dialectical behavior therapy

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Illkirch-Graffenstaden, France

Status

Recruiting

Address

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

Illkirch-Graffenstaden, , 67402

Site Contact

Agata KRASNY-PACINI

[email protected]

+33 3 69 06 30 42

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