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Behavioural Intervention

CBT vs Mindfulness-Based Therapy for Autism

N/A
Recruiting
Led By Brenna Maddox, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Co-occurring depression and/or anxiety as determined by a score ≥10 on the PHQ-ADS depression and/or anxiety subscale
Must not have
Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6-months follow-up
Awards & highlights

Summary

This trial will compare CBT & MBT, two treatments for depression & anxiety in autistic adults, to see which is more effective.

Who is the study for?
This trial is for English-speaking autistic adults over 18 living in North Carolina or Virginia. Participants must have a professional autism diagnosis or score high on an autism screening, and show signs of depression or anxiety. Those with acute mental issues, intoxication, mania, or at risk of suicide cannot join.
What is being tested?
The study compares Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) to see which is more effective for treating depression and anxiety in autistic adults. Both therapies will be given through telehealth sessions.
What are the potential side effects?
While CBT and MBCT are generally safe, some may experience increased anxiety, emotional discomfort during sessions, fatigue after therapy work, or frustration if expected improvements aren't seen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have depression or anxiety with a score of 10 or more on the PHQ-ADS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am mentally capable of understanding and agreeing to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6-months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6-months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in anxiety and depression symptoms
Secondary study objectives
Change in disability
Change in functional impairment
Change in mental health
+7 more

Trial Design

2Treatment groups
Active Control
Group I: Cognitive-Behavioral Therapy (CBT)Active Control1 Intervention
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 II: Mindfulness-Based Cognitive Therapy (MBCT)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,742 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
3,104 Patients Enrolled for Autism Spectrum Disorder
Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
27,249,109 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
3,021 Patients Enrolled for Autism Spectrum Disorder
University of VirginiaOTHER
771 Previous Clinical Trials
1,283,997 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
7,181 Patients Enrolled for Autism Spectrum Disorder
~159 spots leftby Jul 2025
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