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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
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
BEAM Trial 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.Check my eligibility
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).See study design
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.
BEAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 11 and 14 years old.
BEAM Trial 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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
PCC-FPCN rsFC: Seed-based
SART Accuracy
SART: Mind-wandering Awareness Probe
+1 moreBEAM 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.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,806 Total Patients Enrolled
7 Trials studying Mood Disorders
666 Patients Enrolled for Mood Disorders
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,559 Total Patients Enrolled
74 Trials studying Mood Disorders
45,445 Patients Enrolled for Mood Disorders
Danella Hafeman, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an IQ below 70 or a significant learning disability.My parent or sibling has major depression or bipolar disorder.I do not have metal implants or braces, nor plan to get them soon.I have not changed my medications or started new therapy in the last two months.I am between 11 and 14 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Intervention (MBI)
- Group 2: Health and Wellness Intervention (HWI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are members of the geriatric population being welcomed into this research study?
"According to the requirements of this research, potential participants must be aged between 11 and 13 years old."
Answered by AI
Is admittance into this trial currently available to participants?
"This experiment is actively enrolling patients, as indicated by clinicaltrials.gov. This information was first posted on September 23rd 2022 and modified on October 6th of the same year."
Answered by AI
Could I potentially join this clinical experiment?
"This trial is targeting 140 young people between the ages of 11 and 13 who are suffering from mood disorders. Essential conditions for consideration include a parent with either major depressive disorder or bipolar I/II, an elevated score on the Children's Affective Lability Scale (both child and parent averages must exceed 10) and gender neutrality."
Answered by AI
What is the current capacity of enrollees in this clinical trial?
"Affirmative. Clinicaltrials.gov reports that this medical experiment, initially published on September 23rd 2022, is currently seeking participants. 140 individuals are needed across a single clinical site."
Answered by AI
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