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NCT04815239 · ClinicalTrials.gov registry record · NA

Early Intervention for Youth at High Risk for Bipolar Disorder

A NA study of Bipolar Disorder, sponsored by University of Pittsburgh.

Recruiting
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT04815239 is a NA study of Bipolar Disorder that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 120 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04815239, a NA study of Bipolar Disorder, is actively recruiting participants, sponsored by University of Pittsburgh.

RECRUITING
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

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 Studied

Bipolar Disorder

Interventions

  • BEHAVIORAL Interpersonal and Social Rhythm Therapy (IPSRT)
  • BEHAVIORAL The Healthy Lifestyle Behavior Intervention (HL)

Study Locations (1)

Pennsylvania

  • Nicole Arnold - Pittsburgh

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2021-09-01
Est. Completion 2027-04-30
Phase NA

Sponsor

University of Pittsburgh

1,238 total trials

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What the Registry Record Tells You About NCT04815239

The ClinicalTrials.gov registry entry for NCT04815239 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (64% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Interpersonal and Social Rhythm Therapy (IPSRT) is the first listed.

NCT04815239 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04815239 about?

NCT04815239 is a clinical study titled "Early Intervention for Youth at High Risk for Bipolar Disorder". 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 assessme...

What is the current status of trial NCT04815239?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2021-09-01. Estimated completion is 2027-04-30.

What conditions does trial NCT04815239 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT04815239?

The interventions under investigation include: Interpersonal and Social Rhythm Therapy (IPSRT) (BEHAVIORAL), The Healthy Lifestyle Behavior Intervention (HL) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04815239?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04815239 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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