NCT06060860Active, not recruiting
Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Sept 2023
- Start date
- 17 Jan 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Autism
- NCT number
- NCT06060860
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 17 Jan 2024 to the primary completion date, 1 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
- Imminent risk of suicide
Who the study is looking for
- ≥18 years of age
- Co-occurring depression and/or anxiety as determined by a total score ≥10 on the PHQ-ADS
- Living in North Carolina or Virginia
- Ability to participate in therapy sessions over telehealth
- English-speaking
- Provide proof of a professional diagnosis of autism OR meet or exceed clinical cut-off on the Social Responsiveness Scale (SRS-2) autism screening instrument
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.