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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04737707
Other study ID # 8108
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 16, 2021
Est. completion date September 1, 2024

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Luisa WEINER, MD
Phone 03 88 11 65 11
Email weiner.l@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dialectical Behavior Therapy (DBT)
Dialectical Behavior Therapy (DBT)

Locations

Country Name City State
France Service de psychiatrie Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
Primary 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
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