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Mindfulness vs. CBT: which therapy helps autistic adults more?

NCT ID NCT06060860

Symptom relief Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study compares two well-known therapies—cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT)—to see which works better for autistic adults with depression and anxiety. About 300 participants from North Carolina and Virginia will receive therapy via telehealth. The goal is to find out which approach leads to greater improvements in mental health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT)
What this could lead to
If this trial succeeds, it could show which therapy works best for autistic adults with depression and anxiety, leading to more personalized and effective mental health care.
What could go wrong
This is a behavioral intervention study, not a drug trial. Results depend on participant engagement and may not apply to all autistic adults. The therapies are already established, so the main question is which works better, not if they work at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder autism spectrum disorder Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Autism spectrum disorder Depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27510, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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