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

NCT02435225 | Terminated DMC

• 1 other identifier: MH10126001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder, NOS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Degree of Mindfulness

  12 weeks

Study Arms (1)

Mindfulness group

EXPERIMENTAL

Participation in a 12 week mindfulness therapy group.

Behavioral: Mindfulness Based Stress Reduction for Teens Group

Interventions

Mindfulness Based Stress Reduction for Teens Group BEHAVIORAL

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

Mindfulness group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Not English speaking

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kiki D Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: May 6, 2015
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

US (1)