IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk

(KEY Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Tina R Goldstien, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Bipolar I/II, Unstabilized psychiatric, Developmental, CNS, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a telehealth therapy called IPSRT to help children at high risk of bipolar disorder due to having a bipolar parent. The therapy focuses on improving sleep and daily routines to prevent the disorder. The study will monitor outcomes over time. Interpersonal and Social Rhythm Therapy (IPSRT) was specifically developed to manage stressful life events, improve disruptions in social and circadian rhythms, and has shown efficacy in treating bipolar disorder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment IPSRT + Healthy Lifestyle Intervention for reducing the risk of bipolar disorder?

Research shows that Interpersonal and Social Rhythm Therapy (IPSRT) helps stabilize daily routines and improve social functioning in people with bipolar disorder, which can protect against future mood episodes. Additionally, IPSRT has been effective in managing stress, improving medication adherence, and preventing relapses when combined with medication. ^{1 2 3 4 5}

Is IPSRT safe for humans?

Interpersonal and Social Rhythm Therapy (IPSRT) has been studied primarily for bipolar disorder and is generally considered safe as it focuses on stabilizing daily routines and social rhythms, which are non-invasive and supportive strategies. ^{1 2 3 6 7}

How is the IPSRT + Healthy Lifestyle Intervention treatment unique for bipolar disorder?

The IPSRT + Healthy Lifestyle Intervention is unique because it combines Interpersonal and Social Rhythm Therapy (IPSRT), which focuses on stabilizing daily routines and managing social and circadian rhythms, with a Healthy Lifestyle Behavior Intervention to enhance overall lifestyle regularity. This approach not only addresses medication adherence and stressful life events but also aims to prevent mood episodes by promoting regular social rhythms, making it distinct from standard medication-only treatments. ^{1 2 3 5 8}

Research Team

Tina R Goldstien, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

Able/willing to give informed consent/assent

Baseline Risk Calculator score>0.05;

My parent has been diagnosed with Bipolar I or II.

Exclusion Criteria

You have a lifelong blood pressure disorder.

I have a developmental or brain disorder.

You have ongoing and unstable mental health issues.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance, followed by a feedback session

1 week

1 visit (virtual)

Treatment

Participants are randomized to receive 8 sessions of IPSRT or Healthy Lifestyle Behaviors Program over 6 months via telehealth

24 weeks

8 visits (virtual)

Follow-up

Participants are monitored for primary outcome domains including mania and affective lability over 18 months

18 months

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Interpersonal and Social Rhythm Therapy (IPSRT) Active Control 1 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 Control 1 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.

Interpersonal and Social Rhythm Therapy (IPSRT) is already approved in Canada for the following indications:

Approved in Canada as IPSRT for:

• Bipolar disorder
• Bipolar depression

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

References

1. United States pubmed.ncbi.nlm.nih.gov

Inducing lifestyle regularity in recovering bipolar disorder patients: results from the maintenance therapies in bipolar disorder protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adapting interpersonal and social rhythm therapy to the developmental needs of adolescents with bipolar disorder. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of the interpersonal and social rhythm therapy (IPSRT) in patients with bipolar disorder: results from a real-world, controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Interpersonal and social rhythm therapy: a means of improving depression and preventing relapse in bipolar disorder. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Psychoeducation and interpersonal and social rhythm therapy for bipolar disorder]. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Group Interpersonal and Social Rhythm Therapy for Recurrent Mood Disorders: A Pilot Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Interpersonal and social rhythm therapy: an intervention addressing rhythm dysregulation in bipolar disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Interpersonal and social rhythm group therapy for patients with bipolar disorder. [2014]