CBT vs Mindfulness-Based Therapy for Autism

Recruiting at 1 trial location

Overseen By Jessie Bishop

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Acute psychosis, Intoxication, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two popular mental health treatments, cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT), to determine which is more effective for autistic adults with depression or anxiety. Both therapies have proven successful in the past, but the study aims to identify which one benefits those with autism more. Participants will receive therapy sessions via telehealth. The trial seeks autistic adults who have been professionally diagnosed or meet certain screening criteria, live in North Carolina or Virginia, and experience depression or anxiety. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance mental health treatment options for autistic individuals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are safe and well-tolerated for people with autism. CBT effectively helps autistic children and adults improve social skills and reduce anxiety, with studies indicating it manages symptoms without major side effects.

Similarly, MBCT lowers stress, reduces behavioral issues, and enhances thinking skills. Although fewer studies focus on MBCT specifically for autism, existing research highlights its ability to decrease anxiety and depression.

Both therapies have a strong safety record for treating anxiety and depression in the general population, with few reports of negative effects. This suggests they are likely safe for autistic individuals as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to address the emotional challenges often faced by individuals with autism. Cognitive-Behavioral Therapy (CBT) in this trial uses the Unified Protocol, which targets common emotional factors across anxiety and depression, providing a more streamlined and flexible approach than standard CBT. Meanwhile, Mindfulness-Based Cognitive Therapy (MBCT) brings a fresh focus on non-judgmental awareness of the present moment, a technique adapted to specifically enhance mental health by reducing stress and improving emotional regulation. Both approaches offer promising alternatives to traditional therapies by addressing the underlying emotional mechanisms in a novel way.

What evidence suggests that this trial's treatments could be effective for autism?

This trial will compare Cognitive-Behavioral Therapy (CBT) with Mindfulness-Based Cognitive Therapy (MBCT) for autistic adults. Research has shown that both therapies help address mental health issues in this population. Participants in the CBT arm may improve social skills and reduce anxiety and depression by addressing emotional challenges. Meanwhile, those in the MBCT arm may benefit from its focus on being present and accepting feelings without judgment, which can lower anxiety and depression and enhance overall mental well-being. Both therapies have a strong history of managing mental health conditions in autistic individuals. ^{1 4 6 7 8}

Who Is on the Research Team?

Micah Mazurek, PhD

Principal Investigator

University of Virginia

Laura Klinger, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for English-speaking autistic adults over 18 living in North Carolina or Virginia. Participants must have a professional autism diagnosis or score high on an autism screening, and show signs of depression or anxiety. Those with acute mental issues, intoxication, mania, or at risk of suicide cannot join.

Inclusion Criteria

You reside in either North Carolina or Virginia.

You are fluent in English.

You must demonstrate a professional diagnosis of autism or score higher than the clinical threshold on the Social Responsiveness Scale (SRS-2) to qualify.

Exclusion Criteria

I am mentally capable of understanding and agreeing to participate in the study.

You are at a high risk of wanting to harm yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive-Behavioral Therapy (CBT) or Mindfulness-Based Therapy (MBT) delivered by telehealth

18 weeks

Telehealth sessions

Follow-up

Participants are monitored for changes in mental health, self-acceptance, quality of life, and other outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study compares Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) to see which is more effective for treating depression and anxiety in autistic adults. Both therapies will be given through telehealth sessions.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy (CBT) Active Control 1 Intervention

The 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.

Group II: Mindfulness-Based Cognitive Therapy (MBCT) Active Control 1 Intervention

Mindfulness-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.

Cognitive-Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Depression
• Anxiety
• Various psychiatric conditions

Approved in European Union as Cognitive Behavioural Therapy for:

• Depression
• Anxiety
• Post-traumatic stress disorder
• Obsessive-compulsive disorder

Approved in Canada as Cognitive Behavioral Therapy for:

• Depression
• Anxiety
• Bipolar disorder
• Eating disorders

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Augusta University

Collaborator

Trials

219

Recruited

85,900+

Published Research Related to This Trial

In a pilot study involving 35 autistic adults, 66% completed online cognitive behavior therapy or mindfulness-based therapy programs, indicating these self-help tools are generally acceptable for this population.

Participants using these online therapies reported significant reductions in anxiety over 3 to 6 months, suggesting that such tools could be effective for managing anxiety in autistic adults, although broader mental health benefits were less clear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-guided mindfulness and cognitive behavioural practices reduce anxiety in autistic adults: A pilot 8-month waitlist-controlled trial of widely available online tools. Gaigg, SB., Flaxman, PE., McLaven, G., et al.[2021]

Both mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) effectively reduce anxiety and depression symptoms in adults with autism spectrum disorder (ASD), with benefits lasting up to three months after a 13-week treatment period involving 59 participants.

There is no significant difference in overall effectiveness between MBSR and CBT, but MBSR may be more beneficial for individuals with higher baseline levels of irrational beliefs or positive mood, suggesting it could be a preferred option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy and mindfulness based stress reduction may be equally effective in reducing anxiety and depression in adults with autism spectrum disorders. Sizoo, BB., Kuiper, E.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the risk of relapse or recurrence of major depressive disorder (MDD) by 34%, based on a meta-analysis of six randomized controlled trials involving 593 participants.

For patients with three or more previous episodes of MDD, MBCT offers a 43% reduction in relapse risk and is at least as effective as maintenance antidepressant medication, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Piet, J., Hougaard, E.[2022]

In a pilot study involving 16 cancer patients, mindfulness-based cognitive therapy (MBCT) significantly improved mindfulness and reduced anxiety, with lasting effects on depression and anxiety observed at a 3-month follow-up.

Self-compassion was identified as a potential mediator for the improvements in anxiety and depression, suggesting that enhancing self-compassion may play a key role in the effectiveness of MBCT for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for psycho-oncology patients: an exploratory study. Kingston, T., Collier, S., Hevey, D., et al.[2019]

A 9-week mindfulness-based therapy (MBT) program specifically modified for high-functioning adults with autism spectrum disorders (ASD) significantly reduced symptoms of depression, anxiety, and rumination in 42 participants compared to a wait-list control group.

This study is the first controlled trial to show that adults with ASD can benefit from mindfulness-based therapy, highlighting its potential as an effective intervention for mental health issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy in adults with an autism spectrum disorder: a randomized controlled trial. Spek, AA., van Ham, NC., Nyklíček, I.[2018]

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

Mindfulness-based Cognitive Therapy (MBCT) is effective in helping participants with depression develop skills, increase awareness, and gain a sense of agency over their experiences, as shown in a systematic review of 21 qualitative studies.

Participants reported a mix of acceptance and ambivalence towards their mindfulness practices, indicating that while MBCT can lead to meaningful change, it may also present challenges for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. Williams, K., Hartley, S., Langer, S., et al.[2023]

Mindfulness-based therapy (MBT) has been found to be moderately effective for treating psychological issues, with a significant effect size in pre-post comparisons and when compared to waitlist controls, based on a review of 209 studies involving over 12,000 participants.

While MBT shows effectiveness in reducing anxiety, depression, and stress, it does not demonstrate superior efficacy compared to traditional cognitive-behavioral therapy (CBT) or pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy: a comprehensive meta-analysis. Khoury, B., Lecomte, T., Fortin, G., et al.[2022]

Mindfulness-based therapies show promise in improving outcomes for adults with autism spectrum disorder (ASD), but more research is needed to understand the specific components that contribute to their effectiveness.

Future studies should focus on the duration of benefits, the psychological and neural mechanisms behind the changes observed, and the overall breadth of impact these therapies have on individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Reflections on the Therapeutic Effects of Mindfulness-Based Therapies in Adults with Autism and Suggestions for Future Research. Pagni, BA., Braden, BB.[2021]

Mindfulness-based interventions (MBIs) have shown promise in improving emotion regulation in adolescents with autism spectrum disorder (ASD), based on trials involving over 40 participants and 16 clinicians across multiple sites.

The article provides practical strategies for clinicians, especially those untrained in mindfulness, to effectively implement MBIs for adolescents with emotion regulation challenges, making it a valuable resource for enhancing therapeutic delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness "Here and Now": Strategies for Helping Adolescents With Autism. Beck, KB., Conner, CM., White, SW., et al.[2021]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

Mindfulness-Based Cognitive Therapy (MBCT) is as effective as Cognitive Behaviour Therapy (CBT) for treating non-melancholic depression, based on an 8-week study with 45 participants.

Participants with a history of four or more depressive episodes showed greater improvement in depression scores with CBT compared to those with fewer episodes, indicating that CBT may be particularly beneficial for individuals with recurrent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy vs cognitive behaviour therapy as a treatment for non-melancholic depression. Manicavasgar, V., Parker, G., Perich, T.[2022]

In a study involving 104 participants with mild to severe depression and anxiety, all three mindfulness interventions (Mindfulness-Based Cognitive Therapy, Focused Attention, and Open Monitoring) showed medium to large improvements in affective disturbance after 8 weeks, indicating their overall efficacy.

Focused Attention (FA) had the fastest improvement rate but resulted in a loss of treatment gains by week 20, while Mindfulness-Based Cognitive Therapy (MBCT) demonstrated the most favorable long-term outcomes for depression, suggesting it may be the best option for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. Cullen, B., Eichel, K., Lindahl, JR., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33888566/

Cognitive Behavioral Therapy for Autism Spectrum Disorders

Conclusions: These findings indicate that CBT may significantly improve the symptoms of ASD and social-emotional problems in children or adolescents with ASD.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5858576/

Effectiveness of Cognitive Behavioral Therapy for ...

These studies offer promising data on the use of CBT interventions for individuals with ASD and comorbid OCD as well as for individuals with OCD and comorbid ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032723011904

Cognitive behavioural therapy to improve social skills in ...

CBT improved social skills in children with autism compared to controls. CBT is effective in improving social impairment in children with autism.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1750946714002608

Cognitive behaviour therapy for adults with autism ...

Overview. This systematic review aimed to summarise published empirical data regarding the effectiveness of CBT interventions for co-morbid mental health ...

5.

publications.aap.org

publications.aap.org/pediatrics/article-abstract/147/5/e2020049880/180885

Cognitive Behavioral Therapy for Autism Spectrum Disorders

These findings indicate that CBT may significantly improve the symptoms of ASD and social-emotional problems in children or adolescents with ASD.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8991669/

Improving Cognitive Behaviour Therapy for Autistic Individuals

There is emerging evidence of effectiveness of CBT for autistic young people and adults, when compared to treatment as usual, or a wait list or ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01178385

Cognitive-Behavioral Treatment for Anxiety Disorders in ...

Accordingly, we are proposing a randomized controlled trial to examine the efficacy of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with ASD ...

8.

link.springer.com

link.springer.com/article/10.1007/s10803-025-07075-5

Predictors of Treatment Outcomes in Internet-Delivered ...

Cognitive-behavioral therapy (CBT) is considered the gold-standard psychological treatment for anxiety in youth, including those on the autism ...