Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06060860 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 15, 2026 → Mar 1, 2027
See other at-risk trials from University of North Carolina, Chapel Hill

Record History

  1. Primary completion pushed from Aug 15, 2026 to Mar 1, 2027 Enrollment closed, study ongoing · Completion pushed from Feb 15, 2027 to Sep 15, 2027 · Eligibility criteria expanded, about 8 words · 2 more Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Completion pushed from Feb 15, 2027 to Sep 15, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Jul 1, 2025 to Aug 15, 2026 Completion date: Jan 1, 2026 to Feb 15, 2027v8 Show 1 more changeShow less
    • Completion date: Jan 1, 2026 to Feb 15, 2027
  3. Eligibility criteria shortened, about 3 wordsv7 See this version in full on ClinicalTrials.gov ↗
  4. Start date changed from estimate of Jan 5, 2024 to Jan 17, 2024v6
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 1, 2024 to Jan 5, 2024 · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Start date: Jan 1, 2024 to Jan 5, 2024
    • Site details revised at 2 of 2 sites
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Dec 15, 2023 to Jan 1, 2024 Site contacts updated at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  2. Start date: Oct 15, 2023 to Dec 15, 2023v3
  3. Secondary endpoints: details revised at 1 of 10 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06060860
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: University of Virginia, Augusta University, Patient-Centered Outcomes Research Institute
Conditions Autism Spectrum Disorder, Depression, Anxiety
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov