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Regulating Emotions and Behaviors After Brain Injury

NCT05393492 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-05-26

No results posted yet for this 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.

Conditions

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

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.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2022-05-19
Completion
2025-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393492 on ClinicalTrials.gov