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

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

KEY Trial Summary

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.

KEY Trial Eligibility Criteria

Inclusion Criteria

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

KEY Trial Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

KEY 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.

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Who is running the clinical trial?

University of PittsburghLead Sponsor
1,705 Previous Clinical Trials
16,344,977 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this experiment?

"Eligibility into this investigation is based on a diagnosis of manic disorder and age, which should be between 12 to 18 years old. Currently, the research team seeks approximately 120 participants for their trial."

Answered by AI

Is the minimum age for inclusion in this experiment 18 years or older?

"This clinical trial is exclusively for adolescents aged 12 to 18. For those under the age of consent, there are 21 studies available and 114 for octogenarians or older."

Answered by AI

How many individuals have been accepted to participate in this medical study?

"Indeed, the data hosted on clinicaltrials.gov reveals that this medical study is actively searching for participants. This trial was first made available to the public on September 1st 2021 and has been recently updated on March 24th 2022. The goal of this research is to recruit 120 patients from one site."

Answered by AI

What are the expected results of this experiment?

"This clinical trial evaluates the Rate of Subthreshold Manic Symptoms over an 18-month period. As secondary objectives, Actigraphy-derived mean total sleep time, Actigraphy-derived sleep variability and Daily diary-derived mean total sleep time are evaluated."

Answered by AI

Is this experiment presently seeking participants?

"Indeed, the information hosted on clinicaltrials.gov affirms that this research project is presently recruiting. This trial was posted on September 1st 2021 and lastly updated on March 24th 2022; they are looking for 120 participants from one medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Western Psychiatric Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~57 spots leftby Apr 2026