Regulating Emotions and Behaviors After Brain Injury

NCT05393492 | Unknown

• 1 other identifier: 8264
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  15 months

Secondary Outcomes (10)

• Evaluation of the difficulties in emotions regulation

  15 months

• Evaluation of self-esteem

  15 months

• Evaluation of executive functioning

  15 months

• Evaluation of reflective functioning

  15 months

• Evaluation of psychological distress

  15 months

Study Arms (4)

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

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

Interventions

Dialectical Behavior Therapy and Radically Open dialectical behavior therapy BEHAVIORAL

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.

GREMO patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Being 18 years old or more
• Without brain injury
• Non fluent in French
• History of brain injury or brain disease
• History of psychiatric disorder
• Personality disorder

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Illkirch-Graffenstaden, 67402, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Stroke; Ischemia; Brain Neoplasms; Encephalitis; Hypoxia, Brain; Meningitis; Mental Disorders

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Neuroinflammatory Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded analysis of linguistic markers of emotional regulation and free will by an independent laboratory
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: DBT for patients

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: May 26, 2022
• Study Start: May 19, 2022
• Primary Completion: May 19, 2022
• Study Completion: December 1, 2025
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

FR (1)