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Mindfulness-Based Intervention

Mindfulness Training for Mood Disorders (BEAM Trial)

N/A

Recruiting

Led By Danella Hafeman, MD, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females between the ages of 11-14 years

Be younger than 18 years old

Must not have

IQ<70 or significant learning disability

Contraindications to scanning, including metal in the body (e.g. has braces or planning to get braces within the next 8 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the investigators will test specifically for early differences (prior to the mbi/hwi group to immediately following the mbi/hwi group) and assess whether these differences are sustained (immediately following the mbi/hwi group to 3 month follow-up).

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a mindfulness-based intervention to improve mood regulation in early adolescents at high risk for developing mood disorders, in order to better understand how and for whom mindfulness interventions work.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since this trial involves non-medical interventions like mindfulness training and wellness education, side effects are minimal but may include temporary increases in emotional discomfort as participants engage with their feelings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 11 and 14 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the investigators will test specifically for early differences (prior to the mbi/hwi group to immediately following the mbi/hwi group) and assess whether these differences are sustained (immediately following the mbi/hwi group to 3 month follow-up).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the investigators will test specifically for early differences (prior to the mbi/hwi group to immediately following the mbi/hwi group) and assess whether these differences are sustained (immediately following the mbi/hwi group to 3 month follow-up).

This trial's timeline: 3 weeks for screening, Varies for treatment, and the investigators will test specifically for early differences (prior to the mbi/hwi group to immediately following the mbi/hwi group) and assess whether these differences are sustained (immediately following the mbi/hwi group to 3 month follow-up). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

PCC-FPCN rsFC: Seed-based

SART Accuracy

SART: Mind-wandering Awareness Probe

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Mindfulness-Based Intervention (MBI)Active Control1 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 Control1 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.

0 / 3Eligibility criteria met