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

Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02435225

Enrollment

Registered

2015-05-06

Start date

2014-05-31

Completion date

2017-09-30

Last updated

2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, NOS

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.

Interventions

BEHAVIORALMindfulness Based Stress Reduction for Teens Group

A 12-Week weekly group intervention to train adolescents in mindfulness practice

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026