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

Study Overview
=================
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.

Official Title
-----------------
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS

Conditions
-----------------
Bipolar Disorder, NOS

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Stress Reduction for Teens Group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dorsal Medial Network functional connectivity | (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 | (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 | Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved | 12 weeks |