Regulating Emotions and Behaviors After Brain Injury

Last updated: May 23, 2022
Sponsor: University Hospital, Strasbourg, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Neurologic Disorders

Meningitis

Treatment

N/A

Clinical Study ID

NCT05393492
8264
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 theinjury
  • Age between 18 and 68
  • Over 18 months since the acquired brain injury (or 6 month if mild traumaticbrain 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

  • Exclusion criteria:
  • Clinically evident severe lack of insight, lack of abstract reasoning, or severeanosognosia
  • Patients without any complaints
  • Severe cognitive impairments, aphasia or intellectual impairments that doesn'tallow 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 knowledgelinked 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 insightdifficulty…)
  • 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

Study Design

Total Participants: 77
Study Start date:
May 19, 2022
Estimated Completion Date:
December 31, 2025

Study 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)

Connect with a study center

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

    Illkirch-Graffenstaden, 67402
    France

    Active - Recruiting

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