Clinical trial NCT06060860: Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
Official title: Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Depression
Anxiety
Keywords: autism spectrum disorder
depression
anxiety
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Augusta University
name: Patient-Centered Outcomes Research Institute
First posted: 2023-09-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study includes three aims:

Aim 1. Evaluate the effectiveness of two different mental health interventions, CBT versus MBT, to improve patient-centered mental health outcomes, quality of life, well-being, and functional impairment among autistic adults with co-occurring anxiety and/or depressive disorders.

Aim 2. Explore patient characteristics (e.g., expressive language ability, intellectual ability, alexithymia, sensory sensitivity) that may moderate the relationship between CBT or MBT and patient outcomes.

Aim 3. Compare implementation outcomes of acceptability and feasibility of CBT relative to MBT as reported by patients and clinicians using mixed methods.

Eligibility 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

Primary outcomes:
measure: Change in anxiety and depression symptoms
timeFrame: Baseline, up to 18 weeks
Secondary outcomes:
measure: Change in mental health
timeFrame: Baseline through 6 months of follow-up
measure: Change in psychiatric diagnosis
timeFrame: Baseline through 6 months of follow-up
measure: Change in quality of life
timeFrame: Baseline through 6 months of follow-up
measure: Change in well-being
timeFrame: Baseline through 6 months of follow-up
measure: Change in self-acceptance
timeFrame: Baseline through 6 months of follow-up
measure: Change in functional impairment
timeFrame: Baseline through 6 months of follow-up
measure: Change in disability
timeFrame: Baseline through 6 months of follow-up
measure: Potential Negative Effects of Intervention
timeFrame: Up to 6-months follow-up
measure: Intervention services satisfaction
timeFrame: Up to 18 weeks
measure: Intervention therapist and therapy satisfaction
timeFrame: Up to 18 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura Klinger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Micah Mazurek, PhD
role: PRINCIPAL_INVESTIGATOR
References: