Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

Last updated: September 12, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Depression

Williams Syndrome

Treatment

Cognitive-Behavioral Therapy (CBT)

Mindfulness-Based Cognitive Therapy (MBCT)

Clinical Study ID

NCT06060860
23-0871
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years of age

  • Co-occurring depression and/or anxiety as determined by a total score ≥10 on thePHQ-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 clinicalcut-off on the Social Responsiveness Scale (SRS-2) autism screening instrument

Exclusion

Exclusion Criteria:

  • Altered mental status that precludes the ability to provide informed assent orconsent (acute psychosis, intoxication, or mania)

  • Imminent risk of suicide

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Cognitive-Behavioral Therapy (CBT)
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
February 15, 2027

Study Description

This study includes three aims:

Aim 1. Evaluate the effectiveness of two different mental health interventions, CBT versus MBT, to improve patient-centered mental health outcomes, quality of life, well-being, and functional impairment among autistic adults with co-occurring anxiety and/or depressive disorders.

Aim 2. Explore patient characteristics (e.g., expressive language ability, intellectual ability, alexithymia, sensory sensitivity) that may moderate the relationship between CBT or MBT and patient outcomes.

Aim 3. Compare implementation outcomes of acceptability and feasibility of CBT relative to MBT as reported by patients and clinicians using mixed methods.

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27510
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27510
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Active - Recruiting

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