Regulating Emotions and Behaviors After Brain Injury

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · May 23, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Regulating Emotions and Behaviors After Brain Injury," is studying how a specialized therapy called Dialectical Behavior Therapy (DBT) can help people who have experienced an acquired brain injury (ABI), such as from a stroke or brain tumor. After a brain injury, many individuals struggle with emotions and behaviors that can be challenging for both them and their families. The trial aims to see if DBT, which teaches skills to manage emotions, improve relationships, and cope with stress, can enhance quality of life, reduce problematic behaviors, and improve family dynamics for those affected.

To participate in this study, individuals must be between 18 and 68 years old, have had an ABI for at least 18 months, and face emotional or behavioral challenges that impact their daily life. Participants will receive a combination of regular care and DBT over a span of 15 months and will be asked to complete questionnaires to track their progress. Family members of participants can also join the study to provide feedback on their experiences. This trial is currently recruiting, and it's an opportunity for those affected by ABI to potentially gain valuable skills and support.

Gender

ALL

Eligibility criteria

• • 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 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
• * 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
• * 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 knowledge linked 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 insight difficulty...)
• • 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