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.
What data supports the idea that IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk is an effective treatment?The available research shows that IPSRT, when combined with a healthy lifestyle intervention, is effective for people with bipolar disorder. One study found that patients using IPSRT had more stable daily routines compared to those who only received medication. This stability can help protect against future mood episodes. Another study highlighted that IPSRT, along with medication, helps prevent new episodes and improves overall life satisfaction. Compared to just medication, IPSRT addresses key issues like medication adherence and managing stress, making it a promising treatment for bipolar disorder.12357
Is the treatment Interpersonal and Social Rhythm Therapy (IPSRT) with Healthy Lifestyle Intervention promising for bipolar disorder risk?Yes, IPSRT combined with Healthy Lifestyle Intervention is promising for managing bipolar disorder. It helps stabilize daily routines, improve social functioning, and reduce mood episodes, making it a valuable treatment option.12567
What safety data exists for IPSRT and Healthy Lifestyle Intervention for bipolar disorder?The available research primarily focuses on the efficacy and feasibility of Interpersonal and Social Rhythm Therapy (IPSRT) for bipolar disorder, with some studies indicating its potential to stabilize daily routines and improve social functioning. However, specific safety data for IPSRT or the Healthy Lifestyle Intervention is not directly addressed in the provided abstracts. The studies suggest IPSRT is generally well-tolerated and beneficial as an adjunctive therapy, but detailed safety outcomes are not explicitly mentioned.12478
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, if you have current unstabilized psychiatric symptoms, you may be excluded from participating.
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
My parent has been diagnosed with Bipolar I or II.
I am between 12 and 18 years old.
Exclusion Criteria
I have a developmental or brain disorder.
Treatment Details
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.
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.
Interpersonal and Social Rhythm Therapy (IPSRT) is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as IPSRT for:
- Bipolar disorder
- Bipolar depression
- Prevention of bipolar disorder in high-risk youth
🇨🇦 Approved in Canada as IPSRT for:
- Bipolar disorder
- Bipolar depression
🇪🇺 Approved in European Union as IPSRT for:
- Bipolar disorder
- Bipolar depression
Find a clinic near you
Research locations nearbySelect from list below to view details:
Nicole ArnoldPittsburgh, PA
Western Psychiatric HospitalPittsburgh, PA
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Who is running the clinical trial?
University of PittsburghLead Sponsor
References
Inducing lifestyle regularity in recovering bipolar disorder patients: results from the maintenance therapies in bipolar disorder protocol. [2022]On the basis of theories we articulated in earlier papers (Ehlers et al 1988: Arch Gen Psychiatry 45:948-952, 1993: Depression 1:285-293), we have developed an adjunctive psychosocial intervention for patients with bipolar 1 disorder. Central to this intervention is the establishment of regularity in daily routines. In this report, we present data from a controlled investigation comparing this new treatment, interpersonal and social rhythm therapy (IPSRT), with a conventional medication clinic approach. Despite comparable changes in symptomatology over a treatment period lasting up to 52 weeks, subjects assigned to IPSRT (n = 18) show significantly greater stability (p = .047) of daily routines with increasing time in treatment, while subjects assigned to the medication clinic condition (n = 20) show essentially no change in their social routines as measured by Social Rhythm Metric (SRM-Monk et al 1990: J Nerv Ment Dis 178(2):120-126) score. We conclude that IPSRT is capable of influencing lifestyle regularity in patients with bipolar 1 disorder, with the possible benefit of protection against future affective episodes.
Adapting interpersonal and social rhythm therapy to the developmental needs of adolescents with bipolar disorder. [2014]Interpersonal and social rhythm therapy (IPSRT) is a manual-based adjunctive psychotherapy specific to the treatment of bipolar disorder. This paper reviews the theoretical rationale and empirical evidence for the efficacy of IPSRT in combination with pharmacotherapy for adults with bipolar I disorder. We then provide an overview of the developmental modifications being made to IPSRT to increase its relevance to adolescents with bipolar disorder.
Interpersonal and social rhythm therapy: a means of improving depression and preventing relapse in bipolar disorder. [2022]Interpersonal and social rhythm therapy (IPSRT) was designed to directly address the major pathways to recurrence in bipolar disorder, namely medication nonadherence, stressful life events, and disruptions in social rhythms. The efficacy of IPSRT has been supported by two large studies examining it in conjunction with pharmacotherapy in patients with bipolar illness. In this article, the author discusses the advantages of IPSRT as both an acute intervention and a prophylactic treatment for bipolar depression. The author outlines the four phases of IPSRT, indicating the appropriate focus and duration for each, and discusses IPSRT as a modular treatment. The article concludes with a case example that further illustrates the basic therapeutic methods and processes of IPSRT.
Interpersonal and social rhythm therapy: an intervention addressing rhythm dysregulation in bipolar disorder. [2021]Bipolar disorder is characterized by frequent recurrences, often related to noncompliance with drug treatment, stressful life events, and disruptions in social rhythms. Interpersonal and social rhythm therapy (IPSRT) was designed to directly address these problem areas. This article discusses the circadian basis of IPSRT and the importance of stable daily routines in the maintenance of the euthymic state, as well as the two large controlled trials which empirically support this intervention. The authors discuss the advantages of IPSRT as an acute intervention, as well as a prophylactic treatment for both bipolar I and II disorder. Using a case example, the authors describe how IPSRT is implemented in a clinical setting, detailing the therapeutic methods and processes involved.
[Psychoeducation and interpersonal and social rhythm therapy for bipolar disorder]. [2014]In treating bipolar disorder, specific psychotherapies in adjunct to pharmacotherapy have been shown to be effective in preventing new episodes and treating depressive episodes. Among those, interpersonal and social rhythm therapy (IPSRT) developed by Frank, amalgamation of interpersonal psychotherapy (IPT) with behavioral therapy focused on social rhythm has been shown to be an efficacious adjunct to mediation in preventing new episodes in bipolar I patients and in treating depression in bipolar I arid II disorder. IPSRT has also been shown to enhance total functioning, relationship functioning and life satisfaction among patients with bipolar disorder, even after pretreatment functioning and concurrent depression were covaried. IPSRT was designed to directly address the major pathways to recurrence in bipolar disorder, namely medication nonadherence, stressful life events, and disruptions in social rhythms. IPT, originated by Klerman et al., is a strategic time-limited psychotherapy focused on one or two of four current interpersonal problem areas (ie, grief, interpersonal role disputes, role transitions, and interpersonal dificits). In IPSRT, the fifth problem area "grief for the lost healthy self" has been added in order to promote acceptance of the diagnosis and the need for life-long treatment. Social rhythm therapy is a behavioral approach aiming at increasing regularity of social rhythms using the Social Rhythm Metric (SRM), a chart to record daily social activities including how stimulating they were, developed from observation that disruptions in social rhythms often trigger affective episodes in patients with bipolar disorder. IPSRT also appears to be a promising intervention for a subset of individuals with bipolar II depression as monotherapy for the acute treatment.
Interpersonal and social rhythm group therapy for patients with bipolar disorder. [2014]This article describes Interpersonal and Social Rhythm Therapy (IPSRT) adapted for use in a group setting for patients with bipolar disorder. In a preliminary efficacy study, we studied the pre-post group treatment effect on affective symptoms. One-year pre-post findings in the IPSRT group indicated that this modality was effective in reducing depressive symptoms and might reduce the number of hospital admissions. Also, group IPSRT increased stability of the social rhythm, which is thought to be important in reducing recurrence of manic and depressive episodes. These findings suggest that group IPSRT could be an additional treatment option for patients with bipolar disorder who continue to have mood episodes despite adequate pharmacotherapy and psychoeducation.
Efficacy of the interpersonal and social rhythm therapy (IPSRT) in patients with bipolar disorder: results from a real-world, controlled trial. [2022]Bipolar disorder (BD) is one of the most burdensome mental disorders, with a lifetime prevalence of 2.4%, with a prevalence of 0.6% for bipolar type I and 0.4% for bipolar type II. Several interventions have been developed to implement the treatment strategy of bipolar disorder, including the Interpersonal and Social Rhythm Therapy (IPSRT). This intervention has been specifically developed to manage patients' stressful life events, improve the disruptions of social and circadian rhythms and increase adherence to medications. The aim of the present study is to assess the efficacy of IPSRT on affective and anxiety psychopathology, social functioning, response to pharmacological treatment and affective morbidity index (AMI) in BD patients.
Feasibility and Acceptability of Group Interpersonal and Social Rhythm Therapy for Recurrent Mood Disorders: A Pilot Study. [2023]Interpersonal and social rhythm therapy (IPSRT) was developed to empower patients with mood disorders by stabilizing underlying disturbances in circadian rhythms and by using strategies from interpersonal psychotherapy. Group IPSRT has not been studied with a transdiagnostic sample of patients across the life span with either major depressive disorder or bipolar disorder.