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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different therapies can improve the lives of people with Bipolar Disorder by reducing suicidal behavior. It includes a 6-week group-based program featuring treatments such as Cognitive Behavioral Therapy (CBT) tailored for bipolar disorder, Mindfulness-Based Stress Reduction (MBSR), Interpersonal and Social Rhythm Therapy (ISRT), and education about bipolar medications. The trial aims to understand the environmental and psychological factors influencing suicidality and to identify effective treatment methods. English-speaking individuals diagnosed with Bipolar Disorder, who are not experiencing other severe mental health issues, may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for Bipolar Disorder.

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.

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

Research has shown that Bipolar-Specific Cognitive Behavioral Therapy (CBT) is safe and well-tolerated for people with bipolar disorder. It helps manage symptoms without causing major side effects and is recommended as an additional therapy alongside regular treatment.

Studies have found that Interpersonal and Social Rhythm Therapy (ISRT) is also safe and practical for those with bipolar disorder. Participants have found it helpful in maintaining regular social routines, which can improve mood stability.

Mindfulness-Based Stress Reduction (MBSR) is a promising option for treating mood issues, including those related to bipolar disorder. Research suggests it can reduce symptoms of depression and anxiety without causing significant side effects.

Psycho-education and Understanding Bipolar Medications Therapy focuses on teaching patients about their condition and treatment options. This therapy is generally safe, as it involves sharing information rather than taking new medication or undergoing risky procedures.

Overall, these therapies have demonstrated good safety profiles in research, making them promising for individuals considering participation in a clinical trial to help manage bipolar disorder symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines several innovative therapeutic techniques specifically tailored for individuals with Bipolar Disorder. Unlike typical treatments that often focus solely on medication, this approach integrates Bipolar-Specific Cognitive Behavioral Therapy (CBT), Interpersonal and Social Rhythm Therapy (ISRT), Mindfulness-Based Stress Reduction (MBSR), and psycho-education, offering a comprehensive strategy that addresses both emotional regulation and lifestyle management. This holistic approach aims to improve patients' understanding and management of their condition by fostering stability in daily rhythms, enhancing mindfulness, and providing targeted psychological support. By combining these elements, researchers hope to offer more effective and personalized care, potentially leading to better outcomes for those with Bipolar Disorder.

What evidence suggests that this trial's treatments could be effective for Bipolar Disorder?

Research has shown that Bipolar-Specific Cognitive Behavioral Therapy (CBT) can lower depression and mania while improving daily life skills. However, its effectiveness without medication remains uncertain. Interpersonal and Social Rhythm Therapy (ISRT) has boosted mood and reduced symptoms in people with bipolar disorder. Mindfulness-Based Stress Reduction (MBSR) can ease depression and anxiety by helping patients manage their emotions better. Additionally, Psycho-education and Understanding Bipolar Medications Therapy can help individuals adhere to their medication plans and improve overall well-being. In this trial, participants will receive a combination of these therapies in a group intervention program. Each treatment has shown promise in enhancing the quality of life for those with bipolar disorder. ^{1 2 6 7 8}

Who Is on the Research Team?

Dorian Lamis, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8498810/

Cognitive Behavioral Therapy in Treatment of Bipolar Disorder The evidence level of CBT for BD is lower compared to unipolar depression and psychotic disorders. The preventive effect of CBT seems to fade away in patients ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2530312023000486

Efficacy of cognitive behavioural therapy for bipolar disorder Benefits include reduced levels of depression and mania, fewer relapses and recurrences, and higher levels of psychosocial functioning. More studies are needed.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0176849

Efficacy of cognitive-behavioral therapy in patients with bipolar ... CBT is effective in decreasing the relapse rate and improving depressive symptoms, mania severity, and psychosocial functioning, with a mild-to-moderate effect ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... There is little evidence that CBT as a stand-alone treatment (rather than as an adjunct to pharmacotherapy) is effective for the treatment of bipolar disorder.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06973-3

Cognitive behavioural therapy in comparison to treatment as ... A rigorous RCT is needed to evaluate the efficacy of CBT to reduce distressing mood swings and understand to what extent CBT reduces mechanisms ...

6. psychiatrist.com psychiatrist.com/jcp/efficacy-cognitive-behavioral-therapy-bipolar-disorder/

The Efficacy of Cognitive-Behavioral Therapy in Bipolar ... Data Synthesis: · Our analysis revealed a significant benefit of CBT for patients diagnosed with bipolar disorder.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032723011321

Online cognitive behavioral therapy (eCBT) for the ... The findings of this systematic review suggest that eCBT-Bipol has comparable effectiveness to eCBTg in managing depressive symptoms of unipolar and bipolar ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10238953/

Evaluating the Efficacy of Web-Based Cognitive Behavioral ... The proposed study aims to establish the first e-CBT program specific for the treatment of BD-II with residual depressive symptoms.