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

Conditions

• Anxiety
• Autism Spectrum Disorder
• Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cognitive-Behavioral Therapy (CBT) — 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) — 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.

Study Details

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.

Key Dates

Start date

Jan 17, 2024

Status verified

Sep 2025

Primary completion

Aug 15, 2026

Completion

Feb 15, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

Change in anxiety and depression symptoms [ Time Frame: Baseline, up to 18 weeks ]

Central Contacts

• Laura Klinger, PhD
  (919) 966-8183
  [email protected]

Locations (2)

Find similar trials in Chapel Hill, NC

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