Early Intervention for Youth at High Risk for Bipolar Disorder

Running, not enrolling · Not applicable

Conditions studied: Bipolar Disorder

In brief

Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination.

Key facts

Study ID

NCT04815239

Run by

University of Pittsburgh

People needed

119

Starts

2021-09-01

Expected to finish

2027-04-30

Last updated by the study team

2026-06-11

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 12-18 years
• A parent with a diagnosis of BP I or II
• Baseline Risk Calculator score>0.05;
• Able/willing to give informed consent/assent

You may not qualify if…

• A lifetime diagnosis of BP I or II
• Current unstabilized psychiatric symptoms
• Evidence of developmental disorder or central nervous system disorder

Where it is running

• Nicole Arnold — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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