Psycho-education & Understanding Bipolar Medications Therapy + MBSR + ISRT + Bipolar-Specific CBT for Bipolar Disorder

Overseen By Dorian Lamis, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cognitive impairments, Psychotic, Schizophrenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of this treatment for bipolar disorder?

Research shows that Interpersonal and Social Rhythm Therapy (IPSRT), when used alongside medication, is effective in preventing new episodes and treating depression in people with bipolar disorder. It also improves overall functioning and life satisfaction, and group IPSRT has been found to reduce depressive symptoms and stabilize social rhythms, which can help prevent mood episodes. ^{1 2 3 4 5}

Is Interpersonal and Social Rhythm Therapy (IPSRT) safe for humans?

Interpersonal and Social Rhythm Therapy (IPSRT) has been studied in combination with medication for bipolar disorder and is generally considered safe. It has been shown to improve social functioning and life satisfaction without significant safety concerns. ^{2 3 4 5 6}

How is this treatment for bipolar disorder different from other treatments?

This treatment is unique because it combines several therapies, including Bipolar-Specific Cognitive Behavioral Therapy, Interpersonal and Social Rhythm Therapy (IPSRT), and Mindfulness-Based Stress Reduction (MBSR), to address both the emotional and social rhythm disruptions in bipolar disorder. IPSRT, in particular, focuses on stabilizing daily routines and improving medication adherence, which can help prevent mood episodes and improve overall functioning. ^{2 3 4 5 6}

Research Team

Dorian Lamis, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for English-speaking individuals with Bipolar Disorder who can consent to participate. It's not suitable for those with cognitive impairments, organic diseases, dementia, severe substance disorders, acute psychosis, or schizophrenia spectrum disorders.

Inclusion Criteria

I have been diagnosed with Bipolar Disorder.

Able to provide written informed consent

English speaking

Exclusion Criteria

You have problems with thinking or memory.

You have a medical condition that is not stable.

You have a history of experiencing unrealistic thoughts or beliefs that don't match your mood or emotions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week group-based intervention program focusing on interpersonal/social rhythm, mindfulness, and cognitive interventions to cope with Bipolar Depression

6 weeks

Weekly group sessions

Follow-up

Participants are monitored for changes in depressive symptoms, mania, quality of life, aggression, interpersonal needs, and suicide ideation

4 weeks

Treatment Details

Interventions

• Bipolar-Specific Cognitive Behavioral Therapy (CBT)
• Interpersonal and Social Rhythm Therapy (ISRT)
• Mindfulness-Based Stress Reduction (MBSR)
• Psycho-education & Understanding Bipolar Medications Therapy

Trial Overview The study tests a 6-week group intervention program that includes Psycho-education & Understanding Bipolar Medications Therapy, Mindfulness-Based Stress Reduction (MBSR), Interpersonal and Social Rhythm Therapy (ISRT), and Bipolar-Specific Cognitive Behavioral Therapy (CBT).

Participant Groups

Group I: Group Intervention Program Experimental Treatment 4 Interventions

Patients diagnosed with Bipolar Disorder will receive therapy in a group setting of 4 to 12 male and female participants.

Bipolar-Specific Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Bipolar Disorder for:

• Bipolar Disorder
• Suicidal Behavior in Bipolar Disorder

Approved in European Union as Cognitive Behavioural Therapy for Bipolar Disorder for:

• Bipolar Disorder
• Mood Stabilization

Approved in Canada as CBT for Bipolar Disorder for:

• Bipolar Disorder
• Suicidal Behavior

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Findings from Research

Cognitive behavior therapy (CBT) is an effective treatment approach for patients with bipolar disorder, focusing on modifying negative thought patterns and behaviors.

The therapy aims to help patients manage their symptoms, improve mood stability, and enhance overall functioning, although specific techniques and outcomes were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for bipolar disorders]. Lotufo Neto, F.[2019]

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) 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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for bipolar disorders]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

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

6. 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]