IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk

(KEY Trial)

Recruiting at 1 trial 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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Interpersonal and social rhythm therapy (IPSRT) for patients with bipolar 1 disorder led to significantly greater stability in daily routines over a treatment period of up to 52 weeks compared to a conventional medication clinic approach, with 18 participants in the IPSRT group and 20 in the medication group.

While both treatment groups showed similar improvements in symptoms, the IPSRT group demonstrated a measurable impact on lifestyle regularity, which may help protect against future mood episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inducing lifestyle regularity in recovering bipolar disorder patients: results from the maintenance therapies in bipolar disorder protocol. Frank, E., Hlastala, S., Ritenour, A., et al.[2022]

Interpersonal and social rhythm therapy (IPSRT) is an effective adjunctive psychotherapy for adults with bipolar I disorder when used alongside medication, enhancing treatment outcomes.

The therapy is being adapted for adolescents with bipolar disorder, indicating a commitment to making IPSRT relevant and beneficial for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting interpersonal and social rhythm therapy to the developmental needs of adolescents with bipolar disorder. Hlastala, SA., Frank, E.[2014]

Interpersonal and Social Rhythm Therapy (IPSRT) significantly improved symptoms of anxiety and depression, as well as overall functioning in patients with bipolar disorder, compared to standard treatment after 3 and 6 months.

Patients receiving IPSRT also showed a reduction in the affective morbidity index, indicating better management of their condition, suggesting that IPSRT is an effective intervention for bipolar disorder.

NCBI (Pubmed)

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. Steardo, L., Luciano, M., Sampogna, G., et al.[2022]

Interpersonal and social rhythm therapy (IPSRT) effectively addresses key factors that lead to recurrence in bipolar disorder, such as medication nonadherence and disruptions in social rhythms, making it a valuable treatment option.

IPSRT has been validated in two large studies when used alongside pharmacotherapy, demonstrating its efficacy as both an acute intervention and a preventive treatment for bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Interpersonal and social rhythm therapy (IPSRT) is an effective adjunct to medication for preventing new episodes and treating depressive episodes in patients with bipolar I and II disorders, enhancing overall functioning and life satisfaction.

IPSRT specifically targets key factors that contribute to recurrence in bipolar disorder, such as medication nonadherence and disruptions in social rhythms, making it a promising intervention for managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Group interpersonal and social rhythm therapy (IPSRT) was found to be feasible and acceptable for older outpatients with mood disorders, showing a low dropout rate of 24% and high satisfaction scores (32.3 out of 44).

While participants experienced a significant improvement in quality of life three months after treatment, there were no significant changes in depressive symptom scores, indicating that further research is needed to assess the long-term efficacy of group IPSRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Group Interpersonal and Social Rhythm Therapy for Recurrent Mood Disorders: A Pilot Study. Orhan, M., Korten, N., Mans, N., et al.[2023]

Interpersonal and social rhythm therapy (IPSRT) is an effective treatment for bipolar disorder, focusing on stabilizing daily routines to help maintain a stable mood and prevent recurrences.

Two large controlled trials support the efficacy of IPSRT as both an acute intervention and a preventive treatment for bipolar I and II disorders, highlighting its importance in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal and social rhythm therapy: an intervention addressing rhythm dysregulation in bipolar disorder. Frank, E., Swartz, HA., Boland, E.[2021]

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]