Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedStudy Start
First participant enrolled
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
September 18, 2025
September 1, 2025
2.6 years
September 22, 2023
September 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in anxiety and depression symptoms
The Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) is a 16-item composite measure that provides a single composite score for depression and anxiety. It comprises the 9-item Patient Health Questionnaire depression scale (PHQ-9) and the 7-item Generalized Anxiety Disorder scale (GAD-7). PHQ-ADS scores can range from 0 to 48 with higher scores indicating more severe depression/anxiety.
Baseline, up to 18 weeks
Secondary Outcomes (10)
Change in mental health
Baseline through 6 months of follow-up
Change in psychiatric diagnosis
Baseline through 6 months of follow-up
Change in quality of life
Baseline through 6 months of follow-up
Change in well-being
Baseline through 6 months of follow-up
Change in self-acceptance
Baseline through 6 months of follow-up
- +5 more secondary outcomes
Study Arms (2)
Cognitive-Behavioral Therapy (CBT)
ACTIVE COMPARATORThe 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.
Mindfulness-Based Cognitive Therapy (MBCT)
ACTIVE COMPARATORMindfulness-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
- Imminent risk of suicide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- University of Virginiacollaborator
- Augusta Universitycollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (2)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Klinger, PhD
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Micah Mazurek, PhD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2023
First Posted
September 29, 2023
Study Start
January 17, 2024
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
February 15, 2027
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After the publication of the final research report and continuing for a period of at least 7 years.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).