Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT05393492
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05393492
Study Brief:
Protocol Section:
NCT05393492