Mindfulness-Based Therapy for Serious Mental Illness

(MBT Trial)

Overseen By Toni Amaral

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Unstable condition, Mindfulness practice

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of mindfulness-based therapy (MBT) for individuals with serious mental illnesses such as schizophrenia and major mood disorders. It will compare regular treatment alone to regular treatment combined with MBT, which integrates mindfulness exercises with cognitive-behavioral techniques to help manage the illness. Conducted in community mental health centers across the U.S., the study seeks to establish MBT as a common part of mental health care if proven helpful. The trial seeks participants diagnosed with schizophrenia or a major mood disorder who are already receiving care at a community mental health center. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance mental health care practices.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment while participating, as the trial involves adding mindfulness-based therapy to your existing care.

What prior data suggests that mindfulness-based therapy is safe for patients with serious mental illness?

Research has shown that mindfulness-based therapy (MBT) is safe for individuals with serious mental health conditions such as schizophrenia and major mood disorders. Studies have found that MBT can reduce the likelihood of hospitalization or emergency service use, potentially helping individuals remain stable and avoid hospital visits. Other research suggests that group mindfulness sessions can improve symptoms of schizophrenia and depression. Overall, MBT appears to be well-received and beneficial for mental health without causing serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-based therapy is unique because it focuses on enhancing present-moment awareness and acceptance, which is different from traditional treatments for serious mental illness like pharmacotherapy and standard psychotherapy. Most treatments aim to manage symptoms through medication or traditional talk therapy, while mindfulness-based therapy empowers patients by teaching them skills to manage stress and emotions in real-time. Researchers are excited about this approach because it has the potential to improve mental well-being without the side effects often associated with medication, offering a holistic complement to existing treatment options.

What evidence suggests that mindfulness-based therapy might be an effective treatment for serious mental illness?

Research has shown that mindfulness-based therapy (MBT), which participants in this trial may receive, can help individuals with serious mental illness (SMI) feel and function better. Studies from the United Kingdom have found that MBT aids people living in the community in managing their conditions more effectively. Specifically, MBT has reduced symptoms of depression and anxiety, common in SMI. It combines mindfulness exercises with strategies to change thinking patterns, assisting individuals in managing their illness. Moreover, MBT has succeeded even in everyday healthcare settings, suggesting it could be widely adopted. This evidence supports the idea that MBT could be a helpful treatment for those with SMI. ^{1 5 6 7 8}

Who Is on the Research Team?

Brandon Gaudiano, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

This trial is for adults with serious mental illnesses like schizophrenia, major depression, or bipolar disorder. Participants must be receiving care at a community mental health center and able to undergo mindfulness-based therapy alongside their usual treatment.

Inclusion Criteria

Ability to speak and read English

I am currently getting mental health treatment at a community center.

I have been diagnosed with schizophrenia or a major mood disorder.

Exclusion Criteria

Not clinically stable enough to participate in treatment

I practice mindfulness weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mindfulness-Based Therapy (MBT) in a group format for 12 weeks

12 weeks

Weekly group sessions

Midpoint Assessment

Blinded assessments conducted to evaluate progress at the midpoint of the treatment

1 week

1 visit (in-person)

Post-Treatment Assessment

Blinded assessments conducted to evaluate outcomes immediately after treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Based Therapy

Trial Overview

The study tests if adding mindfulness-based therapy (MBT) to the standard treatment helps people with serious mental illness. It compares patients' progress between those who get MBT plus usual care versus just usual care over a period of up to 24 weeks.

How Is the Trial Designed?

Group I: Mindfulness-based therapy Experimental Treatment 1 Intervention

Mindfulness-based therapy is a type of psychotherapy that will be provided in a group format for 12 weeks.

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as usually provided including pharmacotherapy, psychotherapy, and case management as indicated.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study of 98 veterans with psychiatric disorders showed that while attendance in mindfulness-based cognitive therapy (MBCT) was low (average of 4.87 out of 8 sessions), those who attended had a significant reduction in psychiatric hospitalizations after the intervention.

Despite the challenges in implementing MBCT due to high dropout rates, the results suggest that MBCT could be beneficial for veterans at high risk for psychiatric hospitalization, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. Marchand, WR., Yabko, B., Herrmann, T., et al.[2020]

Mindfulness-based interventions have strong evidence supporting their effectiveness in treating mental disorders, particularly depression and anxiety, by helping individuals change their relationship with unhelpful thoughts and emotions.

While home practice can be a barrier for some, it also provides practical tools that can aid in ongoing recovery and well-being, making mindfulness a valuable approach for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in psychiatry - where are we now? Groves, P.[2020]

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 therapies, particularly Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have been shown to effectively improve psychological health, manage pain, and reduce anxiety symptoms.

MBCT is specifically recommended as an additional treatment for unipolar depression, highlighting its role in supporting mental health alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. Marchand, WR.[2022]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

Mindfulness Based Interventions (MBIs) have gained significant traction in recent years for their effectiveness in treating various psychiatric disorders, highlighting their growing importance in mental health care.

Research supports that MBIs work through cognitive, psychological, and neural mechanisms, making them a valuable addition to traditional treatment methods for improving mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. Shapero, BG., Greenberg, J., Pedrelli, P., et al.[2023]

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