Status:
UNKNOWN
Regulating Emotions and Behaviors After Brain Injury
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Acquired Brain Injury
Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05393492
Start Date
May 19 2022
End Date
December 1 2025
Last Update
May 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
Illkirch-Graffenstaden, France, 67402