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IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk (KEY Trial)

Led By Tina R Goldstien, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A parent with a diagnosis of BP I or II
Age 12-18 years
Must not have
Evidence of developmental disorder or central nervous system disorder
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights


This trial is testing whether Interpersonal and Social Rhythm Therapy (IPSRT) can help prevent bipolar disorder in children of parents with bipolar disorder (OBP; age 12-18) who are at elevated risk for the disorder. The therapy will be delivered via telehealth (videoconference) and will include 8 sessions. The primary outcome domains over 18 months include subthreshold mania and affective lability.

Who is the study for?
This trial is for young people aged 12-18 who are at high risk of developing bipolar disorder because they have a parent with the condition. They must be able to understand and agree to the study's procedures. Those with severe psychiatric symptoms, a history of bipolar disorder, or developmental or central nervous system disorders cannot participate.Check my eligibility
What is being tested?
The study tests Interpersonal and Social Rhythm Therapy (IPSRT) against a Healthy Lifestyle Behaviors Program (HL), both delivered via videoconference over eight sessions. The goal is to see which intervention better prevents the onset of bipolar symptoms like mania in these high-risk youths over an 18-month period.See study design
What are the potential side effects?
Since IPSRT and HL are non-medical interventions focusing on therapy and lifestyle changes rather than drugs, side effects may include discomfort from discussing personal issues or changing daily routines but do not involve typical drug-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My parent has been diagnosed with Bipolar I or II.
I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have a developmental or brain disorder.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Subthreshold or Threshold Manic Symptoms
Risk for Subthreshold or Threshold Manic Episodes
Severity of Affective lability
Secondary outcome measures
Sleep variability (objective)
Sleep variability (subjective)
Total sleep time (Objective)
+1 more
Other outcome measures
Exploratory: Association between actigraphy and passive sensing-derived measures of sleep-wake

Trial Design

2Treatment groups
Active Control
Group I: Interpersonal and Social Rhythm Therapy (IPSRT)Active Control1 Intervention
Interpersonal and Social Rhythm Therapy (IPSRT) for at-risk offspring includes 8 sessions over 6 months delivered via secure telemedicine platform. The basis of the intervention is the treatment manual iteratively developed and tested in close consultation with content experts during our open pilot study and R34.The intervention focuses on education about BP risk, stabilizing sleep and daily routines and interpersonal relationships.
Group II: Healthy Lifestyle Intervention (HL)Active Control1 Intervention
HL is based on the treatment manual developed in a prior trial for adults and adolescents with BP. HL includes psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health. In HL, patients are taught to develop and maintain an individualized lifestyle plan and provided support and encouragement for making progress toward their goals. HL clinicians will deliver 8 sessions over 6 months via secure telehealth platform.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Bipolar Disorder often target the regulation of mood and stabilization of circadian rhythms. Interpersonal and Social Rhythm Therapy (IPSRT) specifically aims to stabilize daily routines and improve sleep patterns, which can mitigate mood swings by addressing circadian disruptions. This is crucial for Bipolar Disorder patients as irregular sleep and daily routines can exacerbate mood instability. Other treatments, such as mood stabilizers (e.g., lithium, valproate) and antipsychotics, work by modulating neurotransmitter activity to stabilize mood and prevent manic or depressive episodes. These treatments are essential for managing the chronic and episodic nature of Bipolar Disorder, helping patients maintain a more consistent and functional daily life.
Comorbid Premenstrual Dysphoric Disorder in Women with Bipolar Disorder: Management Challenges.[Treatment of manic phases of bipolar disorder: critical synthesis of international guidelines].Rapid cycling bipolar disorder: historical overview and focus on emerging treatments.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,339,137 Total Patients Enrolled
27 Trials studying Bipolar Disorder
5,629 Patients Enrolled for Bipolar Disorder
Tina R Goldstien, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Interpersonal and Social Rhythm Therapy (IPSRT) Clinical Trial Eligibility Overview. Trial Name: NCT04815239 — N/A
Bipolar Disorder Research Study Groups: Interpersonal and Social Rhythm Therapy (IPSRT), Healthy Lifestyle Intervention (HL)
Bipolar Disorder Clinical Trial 2023: Interpersonal and Social Rhythm Therapy (IPSRT) Highlights & Side Effects. Trial Name: NCT04815239 — N/A
Interpersonal and Social Rhythm Therapy (IPSRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815239 — N/A
~46 spots leftby Apr 2026