IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder Risk

(KEY Trial)

Recruiting at 1 trial location

Overseen By Nicole Arnold, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Interpersonal and Social Rhythm Therapy (IPSRT) or a Healthy Lifestyle Intervention can assist young people at risk of developing bipolar disorder. It focuses on enhancing sleep, daily routines, and overall mental health through telehealth sessions. Participants are youth aged 12-18 with a parent who has bipolar disorder. The study seeks to understand how these treatments might affect mood swings and stress related to sleep issues over 18 months. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could shape future mental health interventions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Interpersonal and Social Rhythm Therapy (IPSRT) is generally safe for people with bipolar disorder. This therapy stabilizes daily routines and relationships, reducing mood swings. Reports have not indicated major negative effects, making IPSRT a well-tolerated option.

For the Healthy Lifestyle Behavior Intervention (HL), studies suggest it is practical and acceptable for those with bipolar disorder. This approach improves habits like diet and exercise, with no known side effects. It promotes a balanced lifestyle to enhance overall health.

Both treatments are safe and available through telehealth, making them easy to access and use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for reducing the risk of bipolar disorder because they focus on lifestyle and interpersonal aspects rather than just medication. Interpersonal and Social Rhythm Therapy (IPSRT) is unique because it helps stabilize sleep and daily routines while improving interpersonal relationships, all delivered via telemedicine, making it accessible and practical. The Healthy Lifestyle Intervention (HL) stands out by providing psychoeducation to create a balanced lifestyle, offering tailored support to optimize both physical and mental health. These approaches aim to address underlying lifestyle factors that can influence bipolar disorder risk, which is a fresh perspective compared to traditional medication-focused treatments.

What evidence suggests that this trial's treatments could be effective for bipolar disorder risk?

This trial will compare Interpersonal and Social Rhythm Therapy (IPSRT) with the Healthy Lifestyle Intervention (HL) for individuals at risk for bipolar disorder. Research has shown that IPSRT can improve mood and reduce the number of bipolar episodes. It also helps individuals adhere to medication schedules and enhances social and daily life skills. Evidence suggests that the HL intervention effectively addresses diet, exercise, and sleep, which are crucial for managing bipolar disorder. This approach focuses on creating a balanced lifestyle and boosting both mental and physical health. Both treatments show promise in helping those at risk for bipolar disorder manage their symptoms and improve overall well-being. ^{2 3 6 7 8}

Who Is on the Research Team?

Tina R Goldstien, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 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

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+

Published Research Related to This Trial

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]

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) 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 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]

A preliminary study of group Interpersonal and Social Rhythm Therapy (IPSRT) for patients with bipolar disorder showed significant reductions in depressive symptoms over one year, indicating its efficacy as a treatment option.

Group IPSRT also improved the stability of social rhythms, which may help prevent future manic and depressive episodes, suggesting it could be beneficial for patients not fully responding to medication and psychoeducation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal and social rhythm group therapy for patients with bipolar disorder. Bouwkamp, CG., de Kruiff, ME., van Troost, TM., et al.[2014]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061484/

Efficacy of the interpersonal and social rhythm therapy ... IPSRT has been confirmed to be effective in improving the clinical symptomology of BD patients and in improving the affective morbidity index.

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/1108410

Two-Year Outcomes for Interpersonal and Social Rhythm ... Lam et al found a reduction in rate of relapse, improved medication adherence, improved psychosocial functioning, fewer days in a bipolar episode, and fewer ...

3. jag.journalagent.com jag.journalagent.com/phd/pdfs/PHD_15_1_81_92.pdf

Effectiveness of interpersonal social rhythm therapy ... Two-year outcomes for interpersonal and social rhythm therapy in individuals with bipolar I disorder. Arch Gen. Psychiatry 2005;62:996–1004 ...

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.psychotherapy.20190035

Clinical Effectiveness Trial of Adjunctive Interpersonal and ... This pragmatic clinical effectiveness trial found that a combination of IPSRT and medication management over 18 months did not significantly improve mood ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05420792

Study Details | NCT05420792 | The Effect of Interpersonal ... Using this versatile approach, IPSRT aims to improve current mood and teach patients skills to protect themselves against the development of new bipolar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3202498/

Interpersonal and social rhythm therapy: an 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 ...

7. withpower.com withpower.com/trial/phase-bipolar-disorder-8-2021-80ada

IPSRT + Healthy Lifestyle Intervention for Bipolar Disorder ... Interpersonal and Social Rhythm Therapy (IPSRT) has been studied primarily for bipolar disorder and is generally considered safe as it focuses on stabilizing ...

8. psychiatrist.com psychiatrist.com/jcp/interpersonal-social-rhythm-therapy-suicidal-ideation-adults-bipolar-ii-depression/

Effects of Interpersonal and Social Rhythm Therapy on ... Results: The results demonstrate a decrease in odds of SI over time (OR=0.8719, 95% CI, 0.8166–0.9309, P≤.001), with a 13% decrease in the odds ...