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Recruiting NCT06060860

NCT06060860 Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

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Clinical Trial Summary
NCT ID NCT06060860
Status Recruiting
Phase
Sponsor University of North Carolina, Chapel Hill
Condition Autism Spectrum Disorder
Study Type INTERVENTIONAL
Enrollment 300 participants
Start Date 2024-01-17
Primary Completion 2026-08-15

Trial Parameters

Condition Autism Spectrum Disorder
Sponsor University of North Carolina, Chapel Hill
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-17
Completion 2026-08-15
Interventions
Cognitive-Behavioral Therapy (CBT)Mindfulness-Based Cognitive Therapy (MBCT)

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Brief 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 Criteria: * ≥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 Exclusion Criteria: * Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania) * Imminent risk of suicide

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