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NCT06060860 · ClinicalTrials.gov registry record · NA

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

A NA study of Depression and Anxiety, sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
2
Study locations

NCT06060860: Recruiting NA study of Depression and Anxiety, sponsored by University of North Carolina, Chapel Hill.

NCT06060860 is a NA study of Depression and Anxiety that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 300 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06060860, a NA study of Depression and Anxiety, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

The Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) is a 16-item composite measure that provides a single composite score for depression and anxiety. It comprises the 9-item Patient Health Questionnaire depression scale (PHQ-9) and the 7-item Generalized Anxiety Disorder scale (GAD-7). PHQ-ADS scores can range from 0 to 48 with higher scores indicating more severe depression/anxiety.

Interventions

  • BEHAVIORAL Cognitive-Behavioral Therapy (CBT)
  • BEHAVIORAL Mindfulness-Based Cognitive Therapy (MBCT)

Study Locations (2)

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2024-01-17
Est. Completion 2027-02-15
Phase NA

What NCT06060860 shows while recruiting

NCT06060860 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (62% lower).

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Cognitive-Behavioral Therapy (CBT) is the first listed.

NCT06060860 reports a single indexed study location in North Carolina, Virginia.

Frequently Asked Questions

What is clinical trial NCT06060860 about?

NCT06060860 is a clinical study titled "Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults". 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...

What is the current status of trial NCT06060860?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-01-17. Estimated completion is 2027-02-15.

What conditions does trial NCT06060860 study?

This clinical trial studies the following conditions: Depression, Anxiety, Autism Spectrum Disorder.

What interventions are being tested in trial NCT06060860?

The interventions under investigation include: Cognitive-Behavioral Therapy (CBT) (BEHAVIORAL), Mindfulness-Based Cognitive Therapy (MBCT) (BEHAVIORAL).

Who is sponsoring clinical trial NCT06060860?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06060860 being conducted?

This trial has 2 study locations across North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06060860's enrollment target sits among peer trials

300 140th of 679 higher than 533 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06060860, the US trial registry maintained by the National Library of Medicine. NCT06060860 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.