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Autism Spectrum DisorderNCT06060860

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

A study testing Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Autism Spectrum Disorder and Depression, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autism Spectrum Disorder, Depression, Anxiety
What is being tested?
Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
17 Jan 2024to 15 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • Altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania)
  • Imminent risk of suicide

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27510

  • University of Virginia

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cognitive-Behavioral Therapy (CBT), Mindfulness-Based Cognitive Therapy (MBCT)
Keywords
autism spectrum disorder, depression, anxiety
Medical subject headings
Autism Spectrum Disorder, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioral Therapy (CBT)Behavioural

    Also called CBT

    The UP incorporates common principles among empirically supported CBT protocols, including restructuring maladaptive cognitions, changing maladaptive behaviors, preventing emotion avoidance, and incorporating exposure. It consists of five core treatment modules:

    1. emotion awareness,
    2. cognitive appraisal \& reappraisal,
    3. emotion avoidance \& emotion-driven behaviors,
    4. awareness and tolerance of emotion-related physical sensations, \&
    5. interoceptive and situational emotion-focused exposures.

    There are two introductory modules on enhancing motivation and understanding of emotional experiences. A final module is on maintenance and relapse prevention. Modules are delivered at a flexible pace and some patients may spend multiple sessions on the same module. The total number of sessions varies from patient to patient, generally ranging from 12-18 sessions (50-60 minutes) delivered weekly. All sessions are 1:1 via telehealth.

  • Mindfulness-Based Cognitive Therapy (MBCT)Behavioural

    Also called MBCT

    The study MBCT protocol is a 9-week program (90-120 minute sessions) with home-based practice between sessions. MBCT sessions incorporate formal mindfulness meditation practices such as sitting meditation, mindful movement, and body scan (with a focus on mindful and non-judgmental attention to sensations, thoughts, and feelings), as well as informal practices and homework to integrate mindful awareness into everyday life, such as mindful eating, mindful walking, and mindful breathing. All sessions are 1:1 via telehealth.

Study groups in NCT06060860
Study groupRoleWhat they receive
Cognitive-Behavioral Therapy (CBT)Active comparatorThe arm receives the Unified Protocol (UP), a modular transdiagnostic CBT treatment that uses a parsimonious approach to treatment by addressing common emotion-related mechanisms underlying both anxiety and depression.
Receives: Behavioral: Cognitive-Behavioral Therapy (CBT)
Mindfulness-Based Cognitive Therapy (MBCT)Active comparatorMindfulness-Based Cognitive Therapy (MBCT) is an empirically supported treatment that focuses on non-judgmental acceptance of present moment experiences and emotions. MBCT was adapted from Mindfulness-Based Stress Reduction (MBSR) to focus on improving mental health more specifically in individuals with depression and other psychiatric conditions.
Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anxiety and depression symptoms

    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.

    Measured: Baseline, up to 18 weeks

Secondary outcomes (10)

  1. Change in mental health

    A patient-centered, single-item Participant Global Rating of Change asks participants to rate their depression/anxiety compared to how it was at the beginning of treatment on a 5-point scale (much better, a bit better, no different, a bit worse, or much worse). The score ranges from 1-5, with higher scores indicate improved depression/anxiety.

    Measured: Baseline through 6 months of follow-up

  2. Change in psychiatric diagnosis

    The Mini-International Neuropsychiatric Interview (MINI) is a widely used, structured clinical interview that was developed as a brief (~15 min), yet comprehensive, assessment of the most common psychiatric diagnoses. The MINI identifies if participants meet diagnostic criteria for major psychiatric disorders. It has 16 modules looking at 24 potential current (within the past 2 weeks or past month) and/or previous psychiatric diagnoses. Questions are rated dichotomously (yes/no) and no score is calculated. Change in total number of current psychiatric diagnoses by participant will be tracked.

    Measured: Baseline through 6 months of follow-up

  3. Change in quality of life

    The Outcome Rating Scale (ORS) is a 4-item visual analog scale assessing functioning in individual, interpersonal, social, and overall functioning over the past week. Item scores range from 0-10, with higher scores indicating better functioning.

    Measured: Baseline through 6 months of follow-up

  4. Change in well-being

    The Patient Reported Outcomes Measurement Information System (PROMIS) is a comprehensive battery of patient-centered measures. The PROMIS Autism Battery - Lifespan (PAB-L), a subset of PROMIS measures, has been validated for the assessment of autistic adults. Items are rated on either a 1 to 7 scale (5 items) or a 1-5 scale (23 items), with total scores ranging from 28 to 150, and higher scores indicating better well-being.

    Measured: Baseline through 6 months of follow-up

  5. Change in self-acceptance

    The 10-item Rosenberg Self-Esteem Scale (RSE) assesses overall self-acceptance. Item scores range from 1 to 4, with total scores ranging from 10-40, with higher scores indicating higher self-esteem.

    Measured: Baseline through 6 months of follow-up

  6. Change in functional impairment

    The brief Sheehan Disability Scale (SDS) will be used to assess the extent to which participants' mental health symptoms have disrupted their day-to-day functioning. The SDS is a 3-item discretized visual analog scale assessing functional disability in work/school, social life, and family life/home responsibilities. Scores range from 0-30, with higher scores indicating a higher degree of functional impairment.

    Measured: Baseline through 6 months of follow-up

  7. Change in disability

    The World Health Organization Disability Assessment Schedule II (WHODAS II) is a brief, 12-item measure of global disability assessing activity limitations and participation. Scores range 12 to 60, where higher scores indicate higher disability or loss of function.

    Measured: Baseline through 6 months of follow-up

  8. Potential Negative Effects of Intervention

    The 20-item Negative Effects Questionnaire (NEQ) measures potential negative effects of psychological treatments. Scores can range from 0 to 80, with higher scores indicating more negative effects.

    Measured: Up to 6-months follow-up

  9. Intervention services satisfaction

    Participants will complete the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure of psychotherapy satisfaction. Scores range from 8 to 32, with higher scores indicating higher satisfaction.

    Measured: Up to 18 weeks

  10. Intervention therapist and therapy satisfaction

    Participants will complete the Survey of Autism Mental Healthcare Satisfaction (SAMHS) to assess specific aspects of mental healthcare important to autistic adults. Scores range from 42-210, with higher scores indicating greater satisfaction.

    Measured: Up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start17 Jan 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060860
Sponsor's protocol ID
23-0871
Status last verified
Oct 2026
First submitted
22 Sep 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Autism Spectrum Disorder and Depression, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anxiety and depression symptoms (time frame: Baseline, up to 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06060860.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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