Multimodal Intervention for Bipolar Disorder

(BTBD Trial)

FA
DG
Overseen ByDaniela Giansante, MSc
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with bipolar disorder in transitioning smoothly from the hospital back to their community. It combines group learning sessions (Group-Based Psychoeducation), peer support, and guidance for local healthcare providers (Personalized Support for Community Healthcare Providers) to enhance understanding of the illness and improve symptom management. The trial is ideal for those diagnosed with bipolar disorder in the last two years who have faced challenges such as psychosis (a mental health condition affecting thoughts and perceptions) or difficulty understanding their illness. Participants should be comfortable communicating in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in managing 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 focuses on adding support like group education and peer support, so it's likely you can continue your current treatment.

What prior data suggests that this multimodal intervention is safe for individuals with bipolar disorder?

Research has shown that the components of the treatment in this study have been safe and well-received in the past. Group-based psychoeducation, where individuals learn together about managing bipolar disorder, has been found to reduce the likelihood of hospitalization. It also enhances feelings of support and understanding about the condition.

Peer support, where individuals with similar experiences assist each other, has demonstrated small positive effects on recovery. Some studies suggest it might not alter symptom severity, but it can enhance social connection.

Lastly, personalized support for healthcare providers has been linked to improved patient care. This involves guiding healthcare providers on better supporting individuals with bipolar disorder, leading to improved mental health outcomes.

Overall, these treatments have shown good results in other studies, indicating they are safe options.12345

Why are researchers excited about this trial?

Researchers are excited about this multimodal intervention for bipolar disorder because it combines several supportive strategies to enhance patient care. Unlike standard treatments, which often focus solely on medication, this approach includes group-based psychoeducation, encouraging patients to learn collaboratively about managing their condition. Additionally, the intervention offers biweekly peer support, providing individuals and families with a community to share experiences and insights. Finally, it includes personalized clinical guidance for community healthcare providers, aiming to tailor care more closely to each patient's needs. This comprehensive strategy could lead to more effective and holistic management of bipolar disorder.

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

This trial will evaluate a Multi-Modal Transitional Care Intervention for bipolar disorder, which includes group-based psychoeducation, peer support, and personalized support for community healthcare providers. Research has shown that group-based education sessions can significantly help people with bipolar disorder by reducing relapse rates and extending the time between episodes. Peer support aids recovery by helping individuals manage better and feel more in control. Personalized support from healthcare providers enhances mental health by improving quality of life. Together, these elements aim to prevent hospital readmissions and support smoother transitions from hospital to community care.23678

Are You a Good Fit for This Trial?

This trial is for individuals with bipolar disorder, specifically those who have recently been discharged from the hospital and are in the early stages of their condition. Participants should be seeking to improve treatment adherence and symptom management.

Inclusion Criteria

Language Proficiency: Must be able to understand and speak English
I am between 18 and 35 years old.
I was diagnosed with bipolar disorder in the last 2 years.
See 1 more

Exclusion Criteria

Severe Psychiatric Conditions: Individuals with a severe psychiatric condition that would prevent them from safely engaging in the intervention
Substance Use Disorder: Individuals with an active substance use disorder that may impact adherence to the intervention
Language Barriers: Participants who do not speak English and are unable to engage in study sessions without language support
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Psychoeducation

Participants attend 6 clinician-facilitated group psychoeducation sessions

8 weeks
6 visits (in-person)

Peer Support

Participants receive biweekly one-on-one peer support sessions

6 months
12 visits (in-person or virtual)

Provider Support

Personalized support for participants' primary healthcare providers with two collaborative sessions

6 months
2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Group-Based Psychoeducation
  • Peer Support
  • Personalized Support for Community Healthcare Provider
Trial Overview The study tests a structured care pathway that includes group-based psychoeducation, individual peer support, and personalized community healthcare provider support to help manage bipolar disorder after hospital discharge.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Multi-Modal Transitional Care InterventionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

St. Joseph's Healthcare Hamilton

Collaborator

Trials
203
Recruited
26,900+

Citations

Application of Psychoeducation-Based Model Group Work ...To explore the value of psychoeducation-based group work in the continuous treatment of patients with bipolar disorder in remission.
Effectiveness of structured group psychoeducation for ...Structured group psychoeducation for bipolar disorder in a low-resource setting has a protective effect against readmission despite limited access to first- ...
The Long-Term Effectiveness of Psychoeducation for ...The data confirm that psychoeducation can impact illness course, in terms of longer time free from hospitalizations.
A Randomized Trial on the Efficacy of Group ...Results Group psychoeducation significantly reduced the number of relapsed patients and the number of recurrences per patient, and increased the time to ...
Clinical effectiveness and acceptability of structured group ...These trials found that 38% of participants allocated to group psychoeducation and 60% of those allocated to group support experienced a bipolar ...
Patients' perspectives of the effects of a group-based ...This study provides support for the beneficial impact of group therapeutic education programs on the personal recovery of people with bipolar disorder.
Patients' perspectives of the feasibility, acceptability and ...Findings demonstrate that group psychoeducation may impact on participants' perceived social support, knowledge and acceptance of bipolar disorder.
'Thriving With Bipolar Disorder': Co-design and Evaluation ...Peer-facilitated group psychoeducation includes the benefits of evidence-based self-management information and tools, with the added advantage of providing ...
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