RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-17
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06060860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Co-occurring depression and/or anxiety as determined by a total score ≥10 on the PHQ-ADS
  3. * Living in North Carolina or Virginia
  4. * Ability to participate in therapy sessions over telehealth
  5. * English-speaking
  6. * 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
  1. * Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
  2. * Imminent risk of suicide

Contacts and Locations

Study Contact

Laura Klinger, PhD
CONTACT
(919) 966-8183
laura_klinger@med.unc.edu

Principal Investigator

Laura Klinger, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Micah Mazurek, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Laura Klinger, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill
  • Micah Mazurek, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-17
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-01-17
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • autism spectrum disorder
  • depression
  • anxiety

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Depression
  • Anxiety