MedTrace Logo

Early Intervention for Youth at High Risk for Bipolar Disorder

NCT04815239 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Interpersonal and Social Rhythm Therapy (IPSRT)

Interpersonal and Social Rhythm Therapy (IPSRT) is an evidence-based treatment for BP adults that prevents or delays mood episodes by stabilizing sleep and daily routines.

BEHAVIORAL

The Healthy Lifestyle Behavior Intervention (HL)

HL includes structured psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Tina R Goldstien, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815239 on ClinicalTrials.gov