Comparing two therapies for mental health in autistic adults
Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
This study is testing whether cognitive-behavioral therapy or mindfulness-based therapy works better to improve mental health for autistic adults dealing with anxiety and depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT06060860 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT) in improving mental health outcomes for autistic adults suffering from co-occurring anxiety and depression. It will evaluate patient-centered outcomes such as quality of life and functional impairment, while also exploring how individual characteristics may influence treatment effectiveness. Both therapies will be delivered via telehealth, making them accessible to participants in North Carolina and Virginia. The study will also assess the acceptability and feasibility of each therapy from the perspectives of both patients and clinicians.
Who should consider this trial
Good fit: Ideal candidates are autistic adults aged 18 and older who experience co-occurring depression and/or anxiety and can participate in telehealth sessions.
Not a fit: Patients with altered mental status or those at imminent risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective mental health interventions for autistic adults, potentially improving their quality of life.
How similar studies have performed: While both CBT and MBT have shown efficacy individually among autistic adults, this head-to-head comparison is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina and 1 other locations
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Laura Klinger, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Laura Klinger, PhD
- Email: laura_klinger@med.unc.edu
- Phone: (919) 966-8183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.