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

University of North Carolina (UNC)

Status: Enrolling

Conditions: Autism Spectrum Disorder; Depression; Anxiety

Treatments: Behavioral: Cognitive-Behavioral Therapy (CBT); Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06060860

23-0871

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Cognitive-Behavioral Therapy (CBT)

Active Comparator group

Description:

The arm receives the Unified Protocol (UP), a modular transdiagnostic CBT treatment that uses a parsimonious approach to treatment by addressing common emotion-related mechanisms underlying both anxiety and depression.

Treatment:

Behavioral: Cognitive-Behavioral Therapy (CBT)

Mindfulness-Based Cognitive Therapy (MBCT)

Active Comparator group

Description:

Mindfulness-Based Cognitive Therapy (MBCT) is an empirically supported treatment that focuses on non-judgmental acceptance of present moment experiences and emotions. MBCT was adapted from Mindfulness-Based Stress Reduction (MBSR) to focus on improving mental health more specifically in individuals with depression and other psychiatric conditions.

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)