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Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders (Autisemo)

Primary Purpose

Autism Spectrum Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dialectical Behavior Therapy (DBT)
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de psychiatrieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dialectical Behavior Therapy (DBT)

Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2021
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT04737707
Brief Title
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders
Acronym
Autisemo
Official Title
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behavior Therapy (DBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dialectical Behavior Therapy (DBT)
Intervention Description
Dialectical Behavior Therapy (DBT)
Primary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.
Time Frame
baseline
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.
Time Frame
at the end of therapy (5 months)
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
The minimum value of the DERS scale is 0 and the maximum is 180. The higher the scores, the more severe the deregulation.
Time Frame
11 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luisa WEINER, MD
Phone
03 88 11 65 11
Email
weiner.l@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Demonsant
Phone
03.88.11.67.68
Email
eric.demonsant@chru-strasbourg.fr
Facility Information:
Facility Name
Service de psychiatrie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Weiner

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders

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