CBT vs Mindfulness-Based Therapy for Autism

Recruiting at 1 trial location

Overseen by Micah Mazurek, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Acute psychosis, Intoxication, Mania, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for autism?

Mindfulness-Based Cognitive Therapy (MBCT) has been shown to help reduce relapse in depression and improve symptoms of anxiety and stress in cancer patients. While this isn't directly about autism, it suggests that MBCT might help with emotional regulation and stress, which can be beneficial for individuals with autism. ^{1 2 3 4 5}

Is Mindfulness-Based Cognitive Therapy (MBCT) safe for humans?

Mindfulness-Based Cognitive Therapy (MBCT) is generally considered safe for humans, as it is a widely recommended treatment for preventing depression relapse and has been studied extensively in clinical settings. ^{2 6 7 8 9}

How does CBT and Mindfulness-Based Therapy differ from other treatments for autism?

CBT and Mindfulness-Based Therapy are unique for autism as they focus on reducing anxiety and depression, which are common in adults with autism. These therapies are tailored to address emotional regulation and can be adapted to individual needs, making them promising options for improving mental health in autistic individuals. ^{10 11 12 13 14}

Research Team

Laura Klinger, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Micah Mazurek, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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

I am 18 years old or older.

You reside in either North Carolina or Virginia.

You are fluent in English.

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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) 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]

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]

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 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 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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for psycho-oncology patients: an exploratory study. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy vs cognitive behaviour therapy as a treatment for non-melancholic depression. [2022]

5. United States 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. [2023]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy: a comprehensive meta-analysis. [2022]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy in adults with an autism spectrum disorder: a randomized controlled trial. [2018]

12. England pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Mindfulness "Here and Now": Strategies for Helping Adolescents With Autism. [2021]

14. England 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. [2021]