Back to resultsBrain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
Primary Purpose
Bipolar Disorder, NOS
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction for Teens Group
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder, NOS
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness group
Arm Description
Participation in a 12 week mindfulness therapy group.
Outcomes
Primary Outcome Measures
Dorsal Medial Network functional connectivity
(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
(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
Degree of Mindfulness
Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02435225
Brief Title
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
Official Title
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Change in goals of PI
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, NOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness group
Arm Type
Experimental
Arm Description
Participation in a 12 week mindfulness therapy group.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction for Teens Group
Intervention Description
A 12-Week weekly group intervention to train adolescents in mindfulness practice
Primary Outcome Measure Information:
Title
Dorsal Medial Network functional connectivity
Description
(1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC)
Time Frame
12 weeks
Title
Functional connectivity of sgACC with thalamus, VMPFC, and amygdala
Description
(2) Investigate level of FC of the sgACC with thalamus, VMPFC, amygdala, and FC of pCing with amygdala/hippocampus, comparing subjects to HC.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Degree of Mindfulness
Description
Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiki D Chang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
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