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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: Recruiting NA study of Bipolar Disorder, sponsored by University of Pittsburgh.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE) Psychiatric Status Ratings (PSR; Range 1-6)
Conditions Studied
Interventions
- BEHAVIORAL Interpersonal and Social Rhythm Therapy (IPSRT)
- BEHAVIORAL The Healthy Lifestyle Behavior Intervention (HL)
Study Locations (1)
Pennsylvania
- Nicole Arnold - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What NCT04815239 shows while recruiting
NCT04815239 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04815239's enrollment target sits among peer trials
120 53rd of 162 higher than 106 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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