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Can talk therapy tame brain Injury's emotional storm?

NCT ID NCT05393492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether dialectical behavior therapy (DBT), a type of talk therapy, can help people with acquired brain injury manage emotional distress and challenging behaviors. 77 participants will receive standard care for 5 months, then DBT for 5 months, then follow-up. Researchers will measure changes in quality of life, emotional regulation, and family burden.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dialectical behavior therapy (DBT)
What this could lead to
If it works, this could offer a way to improve quality of life and emotional control for people with brain injuries.
What could go wrong
This is a small pilot study with no control group, so results may not be conclusive. The therapy is adapted for cognitive issues, which may limit its effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 77 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Illkirch-Graffenstaden, 67402, France

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