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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2027-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive-Behavioral Therapy (CBT)

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.

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

The UP incorporates common principles among empirically supported CBT protocols, including restructuring maladaptive cognitions, changing maladaptive behaviors, preventing emotion avoidance, and incorporating exposure. It consists of five core treatment modules:

1. emotion awareness,
2. cognitive appraisal \& reappraisal,
3. emotion avoidance \& emotion-driven behaviors,
4. awareness and tolerance of emotion-related physical sensations, \&
5. interoceptive and situational emotion-focused exposures.

There are two introductory modules on enhancing motivation and understanding of emotional experiences. A final module is on maintenance and relapse prevention. Modules are delivered at a flexible pace and some patients may spend multiple sessions on the same module. The total number of sessions varies from patient to patient, generally ranging from 12-18 sessions (50-60 minutes) delivered weekly. All sessions are 1:1 via telehealth.

Mindfulness-Based Cognitive Therapy (MBCT)

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.

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

The study MBCT protocol is a 9-week program (90-120 minute sessions) with home-based practice between sessions. MBCT sessions incorporate formal mindfulness meditation practices such as sitting meditation, mindful movement, and body scan (with a focus on mindful and non-judgmental attention to sensations, thoughts, and feelings), as well as informal practices and homework to integrate mindful awareness into everyday life, such as mindful eating, mindful walking, and mindful breathing. All sessions are 1:1 via telehealth.

Interventions

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Cognitive-Behavioral Therapy (CBT)

The UP incorporates common principles among empirically supported CBT protocols, including restructuring maladaptive cognitions, changing maladaptive behaviors, preventing emotion avoidance, and incorporating exposure. It consists of five core treatment modules:

1. emotion awareness,
2. cognitive appraisal \& reappraisal,
3. emotion avoidance \& emotion-driven behaviors,
4. awareness and tolerance of emotion-related physical sensations, \&
5. interoceptive and situational emotion-focused exposures.

There are two introductory modules on enhancing motivation and understanding of emotional experiences. A final module is on maintenance and relapse prevention. Modules are delivered at a flexible pace and some patients may spend multiple sessions on the same module. The total number of sessions varies from patient to patient, generally ranging from 12-18 sessions (50-60 minutes) delivered weekly. All sessions are 1:1 via telehealth.

Intervention Type BEHAVIORAL

Mindfulness-Based Cognitive Therapy (MBCT)

The study MBCT protocol is a 9-week program (90-120 minute sessions) with home-based practice between sessions. MBCT sessions incorporate formal mindfulness meditation practices such as sitting meditation, mindful movement, and body scan (with a focus on mindful and non-judgmental attention to sensations, thoughts, and feelings), as well as informal practices and homework to integrate mindful awareness into everyday life, such as mindful eating, mindful walking, and mindful breathing. All sessions are 1:1 via telehealth.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT MBCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No