NCT04737707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

January 25, 2021

Last Update Submit

January 16, 2026

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (3)

  • Difficulties in Emotion Regulation Scale (DERS)

    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)

    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)

    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

Study Arms (2)

Dialectical Behavior Therapy (DBT)

EXPERIMENTAL

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.

Other: Dialectical Behavior Therapy (DBT)

Therapy

OTHER

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.

Other: Dialectical Behavior Therapy (DBT)

Interventions

Dialectical Behavior Therapy (DBT)OTHER

Dialectical Behavior Therapy (DBT)

Dialectical Behavior Therapy (DBT)Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • ASD diagnosis according to the DSM-5
  • IQ ≥ 70
  • Able to understand and consent to the research aims
  • Membership in a health insurance fund

You may not qualify if:

  • complete hospitalization
  • ongoing CBT or DBT
  • past DBT
  • schizophrenia disorders
  • under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie

Strasbourg, 67000, France

Location

Related Publications (1)

  • Weiner L, Costache ME, Bemmouna D, Rabot J, Weibel S, Dubreucq M, Dubreucq J, Coutelle R. Emotion dysregulation is heightened in autistic females: A comparison with autistic males and borderline personality disorder. Womens Health (Lond). 2023 Jan-Dec;19:17455057231174763. doi: 10.1177/17455057231174763.

    PMID: 37218688RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 4, 2021

Study Start

April 16, 2021

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)