Autism Spectrum DisordersAutisemoNCT04737707
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders
A study testing Dialectical Behavior Therapy (DBT) in people with Autism Spectrum Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Dialectical Behavior Therapy (DBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2021to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- complete hospitalization
- ongoing CBT or DBT
- past DBT
- schizophrenia disorders
- under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Dialectical Behavior Therapy (DBT)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy (DBT)Other
Dialectical Behavior Therapy (DBT)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dialectical Behavior Therapy (DBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 11 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start16 Apr 2021
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737707
- Sponsor's protocol ID
- 8108
- Acronym
- Autisemo
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37218688Weiner L, Bemmouna D. 'I live with my emotions much better now': A qualitative study of autistic adults' subjective experience of dialectical behaviour therapy. Autism. 2025 Nov;29(11):2741-2755. doi: 10.1177/13623613251348271. Epub 2025 Jun 18.
PubMed 40534251
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04737707
- Acronym / sponsor ID
- Autisemo / 8108
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy (DBT) | Experimental | Other: 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. |
| Therapy | Other | Other: Dialectical Behavior Therapy (DBT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- complete hospitalization
- ongoing CBT or DBT
- past DBT
- schizophrenia disorders
- under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior Therapy (DBT)Dialectical Behavior Therapy (DBT) | Other | Dialectical Behavior Therapy (DBT), Therapy |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 37218688Weiner 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.
- Derived from this study: PubMed 40534251Weiner L, Bemmouna D. 'I live with my emotions much better now': A qualitative study of autistic adults' subjective experience of dialectical behaviour therapy. Autism. 2025 Nov;29(11):2741-2755. doi: 10.1177/13623613251348271. Epub 2025 Jun 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy (DBT) in people with Autism Spectrum Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.