RecruitingNot ApplicableNCT04815239

Early Intervention for Youth at High Risk for Bipolar Disorder


Sponsor

University of Pittsburgh

Enrollment

120 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria3

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

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Interventions

BEHAVIORALInterpersonal 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.

BEHAVIORALThe 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.


Locations(1)

Nicole Arnold

Pittsburgh, Pennsylvania, United States

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NCT04815239


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