Regulating Emotions and Behaviors After Brain Injury

NCT ID: NCT05393492

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2025-12-31

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.

Detailed 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)

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy and Radically Open dialectical behavior therapy

Intervention Type: 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.

Controls without brain injury

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

• 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

• 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

• Aphasia or dysarthria not allowing understandable recording
• Impossibility to understand oral questions
• Non fluent in French

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Illkirch-Graffenstaden, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Agata KRASNY-PACINI

Role: primary

agata.krasny-pacini@ugecam.assurance-maladie.fr

+33 3 69 06 30 42

Other Identifiers

8264

Identifier Type: -

Identifier Source: org_study_id