Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

⁃ 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

Locations
Other Locations
France
Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
RECRUITING
Illkirch-graffenstaden
Time Frame
Start Date: 2022-05-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 77
Treatments
Experimental: GREMO patients
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
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
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov