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New treatment option for Acquired Brain Injury
Official title Regulating Emotions and Behaviors After Brain Injury
ClinicalTrials.gov ID: NCT05393492
What this study is testing
- What it's testing
- 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).
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Eligibility Criteria: \ (Limit: 15,000 characters) Summary criteria for participant selection. Main eligibility criteria GREMO patients :
- 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
You likely can't join 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
See the full eligibility criteria
- Eligibility Criteria: \ (Limit: 15,000 characters) Summary criteria for participant selection. Main eligibility criteria GREMO patients :
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Illkirch-Graffenstaden, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Illkirch-Graffenstaden, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.