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

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

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.

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