Mindfulness Training for Mood Disorders

(BEAM Trial)

Overseen By Ashley Harbaugh, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Psychotropic, Hormonal contraceptives

Disqualifiers: Bipolar, Schizophrenia, Autism, others

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

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mindfulness training can help early adolescents at high risk for mood disorders, such as depression or bipolar disorder, manage their emotions better. Researchers will compare two groups: one will engage in mindfulness-based exercises (Mindfulness-Based Intervention or MBI), while the other will focus on general health and wellness topics. The study targets young people aged 11-14 who have a parent or sibling with a major mood disorder and frequently experience rapid mood changes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance emotional management strategies for young people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have changed medications or doses in the past two months, you may not be eligible to participate.

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

Research shows that mindfulness-based programs are generally safe and well-tolerated, with few side effects. They have been used to help with anxiety, depression, stress, and other conditions. Studies have found that these programs can improve emotional management, making them a safe choice for addressing mood issues.

The Health and Wellness Intervention (HWI) aims to enhance health aspects like sleep, exercise, and nutrition. Although detailed safety data specifically for HWI is not available, similar health programs usually present no major safety concerns. They support overall well-being and are designed to be accessible for young people.

In summary, both mindfulness-based and health and wellness programs appear to be safe options based on current research and the nature of these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Based Intervention (MBI) for mood disorders because it offers a fresh approach, emphasizing mindfulness rather than medication or traditional psychotherapy. Unlike standard treatments like antidepressants or cognitive-behavioral therapy, MBI focuses on teaching young people mindfulness practices to help them manage their thoughts and emotions in real-time. This method encourages participants to become more aware of their present experiences, which can lead to improved emotional regulation and reduced stress. Moreover, involving parents in the process and integrating weekly home practices make this intervention a holistic experience that could foster better communication and understanding within families, potentially enhancing its effectiveness.

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

Research has shown that mindfulness-based interventions (MBI), which participants in this trial may receive, can effectively improve mood disorders. Studies have found that MBI significantly enhances mood, with a strong impact measured at about 0.95. These interventions help reduce symptoms of anxiety and depression, similar to cognitive behavioral therapy (CBT). In contrast, the Health and Wellness Intervention (HWI), another treatment option in this trial, is somewhat effective in managing stress and anxiety but generally has a smaller effect on depression. Overall, stronger evidence supports MBI for improving mood-related issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Danella Hafeman, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for early adolescents aged 11-13 with high mood swings and a family history of major depression or bipolar disorder. They must not have metal in their body, recent suicidal thoughts, medication changes within two months, an IQ below 70, significant learning disabilities, or certain psychiatric diagnoses.

Inclusion Criteria

My parent or sibling has major depression or bipolar disorder.

Elevated mood lability, defined as >10 on the Children's Affective Lability Scale (averaging the child and parent score)

I am between 11 and 14 years old.

Exclusion Criteria

I have an IQ below 70 or a significant learning disability.

Suicidal or homicidal ideation within the past month

I do not have metal implants or braces, nor plan to get them soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intake Assessment

Intake assessment to confirm diagnosis and obtain necessary data for eligibility

1 week

1 visit (in-person)

Treatment

Participants receive an 8-week mindfulness-based intervention (MBI) or health and wellness program (HWI)

8 weeks

8 weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 months

4 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Health and Wellness Intervention
• Health-Enhancement Program
• MBI

Trial Overview The study tests whether mindfulness-based interventions can help young teens at risk for mood disorders control their emotions better. Participants will be randomly assigned to either the Mindfulness-Based Intervention (MBI) or a Health and Wellness Intervention (HWI).

How Is the Trial Designed?

Group I: Mindfulness-Based Intervention (MBI) Active Control 1 Intervention

The MBI is based on mindfulness-based stress reduction and mindfulness-based cognitive therapy, borrowing publicly available materials from the Mindfulness in Schools Program and Acceptance and Commitment Therapy. The MBI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth. Group content will consist of brief, age-appropriate mindfulness practices, videos, and discussions to engage participants. Parents will be involved at the beginning of each session and will receive a handout detailing session content. Each week will focus on a different aspect of mindfulness: introduction to mindfulness, attention, being with internal experiences, the stories minds tell, watching thought traffic, waking up to now, flow, and wrap-up/mindfulness in daily life. A home practice given each week will be discussed at the next group. Groups will be taught by two trained instructors with an ongoing mindfulness practice, who have training and experience teaching mindfulness to youth.

Group II: Health and Wellness Intervention (HWI) Active Control 1 Intervention

The control intervention, Health and Wellness Intervention (HWI), is a manualized intervention that's inspired by the Health Enhancement Program that has been adapted for youth 11-14 years old, using brief, engaging, and age-appropriate activities to address topics related to physical and mental health. HWI consists of 8 weekly groups, 45-60 minutes in length, and include 3-8 youth. Parents will be involved at the beginning of each session and will receive a handout detailing session content. HWI will include the following modules: stress management, social support, strengths and values, sleep health, nutrition, and exercise. As with the MBI, a home practice given each week will be discussed at the next group. Groups will be taught by two trained instructors without extensive mindfulness practice or training. The intervention will be matched on time and social interaction, but the HWI will not contain any mindfulness or cognitive behavioral therapy (CBT) components.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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]

Mindfulness-based interventions (MBI), particularly Mindfulness-Based Cognitive Therapy, show promising results in reducing suicidal thoughts and behaviors, especially in patients with Major Depressive Disorder (MDD), based on a systematic review of 14 studies.

Different MBI protocols, including Mindfulness-Based Stress Reduction and Daily Mindfulness Meditation Practice, have also been effective in lowering factors associated with suicide risk, suggesting that these interventions can be beneficial in mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness on suicidal behavior: a systematic review. de Aguiar, KR., Bilhalva, JB., Cabelleira, MD., et al.[2023]

A systematic review of 11 randomized controlled trials involving mindfulness-based interventions (MBIs) and cognitive behavioral therapy (CBT) found no significant difference in their effectiveness for reducing anxiety, depression, and improving sleep quality.

However, MBIs showed a slight advantage for general anxiety symptoms, while CBT had a small edge in specific anxiety measures like the Liebowitz Social Anxiety Scale and Social Phobia Inventory, suggesting both therapies can be effective alternatives for treating anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy versus cognitive behavioral therapy for people with anxiety symptoms: a systematic review and meta-analysis of random controlled trials. Li, J., Cai, Z., Li, X., et al.[2021]

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction and mindfulness-based cognitive therapy, have been shown to effectively reduce symptoms of anxiety and depression across various populations.

MBIs consistently outperform non-evidence-based treatments and are comparable in efficacy to cognitive behavior therapy (CBT), indicating their strong potential as a therapeutic option for mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Anxiety and Depression. Hofmann, SG., Gómez, AF.[2018]

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]

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 interventions (MBIs) showed significant effectiveness compared to no treatment and treatment-as-usual for common mental disorders, with effect sizes of 1.07 and 0.40, respectively, based on a systematic review of 19 randomized controlled trials involving various CMDs.

However, MBIs did not demonstrate significant advantages over placebo or other active treatments, and the overall evidence base for their efficacy in the acute phase of CMDs is considered weak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The empirical support for mindfulness-based interventions for common psychiatric disorders: a systematic review and meta-analysis. Hedman-Lagerlöf, M., Hedman-Lagerlöf, E., Öst, LG.[2019]

Mindfulness-Based Interventions (MBIs) have been shown to be effective for patients with both psychiatric issues and chronic physical health conditions, highlighting their versatility in healthcare.

Despite their proven benefits, the adoption of MBIs in clinical settings is slow, necessitating better integration into medical education, more qualified instructors, and further research on their effectiveness and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How can mindfulness contribute to health care?] Speckens, AEM., Cillessen, L.[2021]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

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) have been shown to effectively improve a wide range of biopsychosocial conditions, such as depression, anxiety, and stress, and are considered relatively safe for use in various settings like healthcare, schools, and workplaces.

Despite their effectiveness, there is a need for more high-quality research to confirm the benefits of MBIs for certain conditions, such as PTSD and ADHD, and to explore their cost-effectiveness across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions: an overall review. Zhang, D., Lee, EKP., Mak, ECW., et al.[2021]

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