Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)

Not Applicable

Terminated

• Conditions: Bipolar Disorder, NOS
• Interventions: Behavioral: Mindfulness Based Stress Reduction for Teens Group

• Registration Number: NCT02435225
• Lead Sponsor: Stanford University

Brief Summary

The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-07
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Study Completion: 2017-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Ages 13-17
• Diagnosed with BD-NOS
• First or second degree relative diagnosed with bipolar I or II

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Exclusion Criteria

• Not English speaking
• For those who are to participate in the MRI scan, having any metal in the body or movement disorders will be an exclusionary factor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness group	Mindfulness Based Stress Reduction for Teens Group	Participation in a 12 week mindfulness therapy group.

Primary Outcome Measures

Name	Time	Method
Dorsal Medial Network functional connectivity	12 weeks	(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala	12 weeks	(2) Investigate level of FC of the sgACC with thalamus, VMPFC, amygdala, and FC of pCing with amygdala/hippocampus, comparing subjects to HC.

Secondary Outcome Measures

Name	Time	Method
Degree of Mindfulness	12 weeks	Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States