- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737707
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders (Autisemo)
January 16, 2026 updated by: University Hospital, Strasbourg, France
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial
Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders.
However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability.
This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67000
- Service de psychiatrie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥ 18 years old
- ASD diagnosis according to the DSM-5
- IQ ≥ 70
- Suicidal ideas, suicidal attempts and/or self-harm behaviors 6 months prior to the inclusion
- Able to understand and consent to the research aims
- Membership in a health insurance fund
Exclusion Criteria:
- complete hospitalization
- ongoing CBT or DBT
- past DBT
- schizophrenia disorders
- under guardianship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dialectical Behavior Therapy (DBT)
Psychotherapy (duration 5 months) will begin within a maximum of 1 month (the time to set up the group) and will be accompanied by individual follow-up.
Evaluations will be carried out within 6 months of the end of the psychotherapy in order to measure its effects.
|
Dialectical Behavior Therapy (DBT)
|
|
Other: Therapy
waiting list for 5 months before starting psychotherapy (duration 5 months).
During this time, the patient can continue your usual therapeutic follow-ups.
Likewise, assessments will be carried out within 6 months after the end of the psychotherapy in order to measure its effects.
the patient will thus benefit from DBT regardless of the group.
|
Dialectical Behavior Therapy (DBT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: baseline
|
The minimum value of the DERS scale is 0 and the maximum is 180.
The higher the scores, the more severe the deregulation.
|
baseline
|
|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: at the end of therapy (5 months)
|
The minimum value of the DERS scale is 0 and the maximum is 180.
The higher the scores, the more severe the deregulation.
|
at the end of therapy (5 months)
|
|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 11 months follow-up
|
The minimum value of the DERS scale is 0 and the maximum is 180.
The higher the scores, the more severe the deregulation.
|
11 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2021
Primary Completion (Actual)
June 1, 2025
Study Completion (Actual)
June 1, 2025
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorders
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Antonella CostantinoIRCCS Eugenio Medea; Azienda Socio Sanitaria Territoriale della Valle OlonaRecruiting
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Institut National de la Santé Et de la Recherche...Completed
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Fondation de France; Fondation Malakoff...Completed
-
University Hospital, Strasbourg, FranceCompletedAutism Spectrum DisordersFrance
-
Adia Med of Winter Park LLCActive, not recruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
Clinical Trials on Dialectical Behavior Therapy (DBT)
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedSuicide | Post-traumatic Stress Disorder | Self-injurious BehaviorUnited States
-
University of Maryland, BaltimoreRecruitingSuicide | PsychosisUnited States
-
Mackay Memorial HospitalNational Science Council, TaiwanCompletedBorderline Personality DisorderTaiwan
-
University of OldenburgProf. René Hurlemann; Jella Voelter, M.Sc.RecruitingBorderline Personality Disorder (BPD)Germany
-
Haukeland University HospitalRecruitingSuicidal Ideation | Self-harm | Suicide and Self-harmNorway
-
Emory UniversityCompleted
-
Uppsala University HospitalThe Söderströmska-Königska Foundation; Fonden för psykisk hälsa; Forskningsrådet...RecruitingAnorexia Nervosa | Feeding and Eating Disorders | Eating Disorders | Anorexia Nervosa, AtypicalSweden
-
Washington University School of MedicineCompletedAnorexia Nervosa | Obsessive-Compulsive Disorder | Social Phobia | Depression, AnxietyUnited States
-
VA Office of Research and DevelopmentRecruitingPost-traumatic Stress Disorder (PTSD) | Self-directed ViolenceUnited States
-
University of North Carolina, CharlotteOhio State University; United States Naval Medical Center, PortsmouthActive, not recruitingDepression | PTSD | Anxiety | Suicidal Ideation | Suicide, Attempted | Coping SkillsUnited States