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

July 17, 2018 updated by: Stanford University

Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness group
Participation in a 12 week mindfulness therapy group.
Behavioral: Mindfulness Based Stress Reduction for Teens Group
A 12-Week weekly group intervention to train adolescents in mindfulness practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dorsal Medial Network functional connectivity
Time Frame: 12 weeks
(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
12 weeks
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Mindfulness
Time Frame: 12 weeks
Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Kiki D Chang, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH10126001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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