e-CBT for Bipolar Disorder

Overseen by Nazanin Alavi

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Nazanin Alavi

Disqualifiers: Acute hypomania, Psychosis, Substance use, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The lifetime prevalence of Bipolar II is 0.4% with the time spent with depressive symptoms outnumbering the time spent with hypomanic symptoms by 35 to 1. Regarding current treatment options, psychotherapy is effective for managing depressive symptoms, with CBT being particularly efficacious. Unfortunately, CBT is often not a feasible treatment option. Electronic CBT (e-CBT) is more accessible for treating various mental illnesses with evidence suggesting it can increase treatment adherence and patient satisfaction. Moreover, e-CBT is suggested to have comparable outcomes to in-person CBT in the treatment of depression and anxiety. Typically, patient-clinician interactions of e-CBT are administered through email however, this is an insecure, unsustainable, and non-scalable treatment delivery method. The proposed study will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for the delivery of e-CBT. The aim is to evaluate the feasibility and effectiveness of using OPTT for the treatment of BAD-II with depressive symptoms, while also analyzing social, cultural, and personal factors affecting patients' experience. Participants (n = 80) diagnosed with BAD-II in a depressive episode will be recruited from the Mood and Anxiety Clinic at Providence Care Hospital in Kingston, Ontario, Canada. Eligible participants will then be randomly assigned to either the treatment group (e-CBT plus treatment as usual (TAU)) (n = 40) or the control group (TAU) (n = 40) where they will complete the 12-week program. Participants in the TAU group will be offered the e-CBT program after the first 12 weeks if they wish to take part. Participants in the e-CBT group will complete weekly modules mirroring in-person CBT content and complete homework assignments that will be evaluated by a clinician who will provide personalized feedback through OPTT. Progression/regression of participants will be analyzed using the MADRS, YMRS, and CGI-BP-M questionnaires administered at baseline, after week 6, and after week 12. Personal, social, and cultural factors impacting participant experience will be investigated through an in-depth interview utilizing focus groups. The findings from this study will be the first on the effectiveness of delivering e-CBT to patients with BAD-II with residual depressive symptoms. This approach can provide an innovative method to address the barriers associated with in-person psychotherapy.

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

The trial does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the study involves adding e-CBT to your existing care.

What data supports the effectiveness of the treatment e-CBT for Bipolar Disorder?

Research shows that internet-delivered cognitive behavioral therapy (iCBT) can significantly reduce symptoms of anxiety and depression in people with bipolar disorder, with large improvements reported in psychological distress and patient satisfaction. This suggests that e-CBT could be a promising treatment option for managing bipolar disorder. ^{1 2 3 4 5}

How is e-CBT different from other treatments for bipolar disorder?

e-CBT (Electronic Cognitive Behavioral Therapy) is unique because it is delivered online, allowing patients to access therapy from home, which can increase accessibility and convenience. It focuses on helping patients identify and change unhelpful thoughts and behaviors, and has shown effectiveness in reducing symptoms of depression and anxiety in people with bipolar disorder, especially when used alongside medication like Lithium. ^{5 6 7 8 9}

Research Team

Nazanin Alavi

Principal Investigator

Kingston Health Sciences Centre

Eligibility Criteria

This trial is for individuals with Bipolar Disorder II (BAD-II) currently experiencing depressive symptoms. They must have reliable internet access, understand and speak English, and be able to consent to participate. People are excluded if they've had CBT in the last year, show active suicidal or homicidal thoughts, are in a hypomanic/manic phase, have acute psychosis or severe substance abuse issues.

Inclusion Criteria

You can easily and consistently connect to the internet.

Your depression severity score falls between 7 and 34 on the MADRS scale.

You have been diagnosed with Bipolar Disorder - 2.

Exclusion Criteria

You are currently undergoing or have undergone cognitive-behavioral therapy (CBT) within the past year.

You are currently thinking about hurting yourself or someone else.

You are currently experiencing a sudden and intense change in mood that makes you feel overly excited or energized.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive e-CBT through OPTT for 12 weeks, completing weekly modules and homework assignments

12 weeks

Weekly online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment using MADRS, YMRS, and CGI-BP-M questionnaires

4 weeks

2 visits (in-person)

Open-label extension (optional)

Participants in the control group are offered the e-CBT program after the first 12 weeks

12 weeks

Treatment Details

Interventions

• e-CBT (Behavioral Intervention)

Trial Overview The study tests electronic Cognitive Behavioural Therapy (e-CBT) using a secure platform called OPTT versus usual treatment for managing depression in BAD-II patients. It involves weekly modules and homework reviewed by clinicians over 12 weeks. The effectiveness will be measured through questionnaires and interviews.

Participant Groups

Group I: e-CBT Experimental Treatment 1 Intervention

All e-CBT sessions will be administered through OPTT and will consist of approximately 30 slides per week. The content and format of each weekly online session will be designed to mirror in-person CBT for the treatment of BAD-II. Participants will complete the module and submit the assigned homework to their clinician through OPTT where the clinician will be able to provide personalized feedback. These pre-designed engaging and multimedia modules will be able to streamline the therapy process, helping care providers save time on repeating similar materials to all patients and focusing on delivering personalized feedback to each patient. The slides will highlight a different topic each week and include general information, an overview of skills, and homework that is to be completed within that week. All weekly sessions have an estimated completion time of 50 minutes. During the 12 weeks, both groups will continue with their TAU.

Group II: Treatment as Usual Active Control 1 Intervention

Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.)

e-CBT is already approved in Canada for the following indications:

Approved in Canada as e-CBT for:

• Depression
• Anxiety disorders
• Phobias
• PTSD
• Sleep disorders
• Eating disorders

Who Is Running the Clinical Trial?

Dr. Nazanin Alavi

Lead Sponsor

Trials

14

Recruited

1,100+

Dr. Nazanin Alavi

Lead Sponsor

Trials

14

Recruited

1,100+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Marie Evangelista

Queen's University

Chief Executive Officer

PhD in Cell and Molecular Biology from Queen's University, Ontario, Canada

Constantine Kreatsoulas

Queen's University

Chief Medical Officer since 2021

PhD in Chemistry from Princeton University

Online PsychoTherapy Clinic

Collaborator

Trials

9

Recruited

710+

Findings from Research

A web-based self-management intervention called 'Living with Bipolar' (LWB) was tested in a randomized controlled trial with 122 participants, showing promising improvements in quality of life and wellbeing compared to a waiting list control group.

The study demonstrated that online interventions for Bipolar Disorder are feasible and could enhance access to psychological therapies, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based self-management intervention for Bipolar Disorder 'living with bipolar': a feasibility randomised controlled trial. Todd, NJ., Jones, SH., Hart, A., et al.[2022]

An internet-delivered, clinician-supported self-management intervention for bipolar disorder was found to be feasible and acceptable, with 15 patients participating over a 10-week period and showing significant improvements in personal recovery.

The study highlighted the potential of digital interventions to enhance treatment accessibility for bipolar disorder, although barriers to implementation need to be addressed for broader adoption in public mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internet-delivered self-management programme for bipolar disorder in mental health services in Ireland: Results and learnings from a feasibility trial. Enrique, A., Duffy, D., Lawler, K., et al.[2022]

A systematic review identified 29 studies focused on Internet-based psychological interventions for bipolar disorder, highlighting the growing interest in using technology to support these patients.

While the evidence on the efficacy of these interventions remains inconclusive, high retention and compliance rates suggest that they could be a feasible and acceptable option for delivering psychological support to bipolar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based psychological interventions for bipolar disorder: Review of the present and insights into the future. Hidalgo-Mazzei, D., Mateu, A., Reinares, M., et al.[2022]

A study involving 83 patients with bipolar disorder who were taking Lithium showed that internet-delivered cognitive behavior therapy (iCBT) significantly reduced symptoms of depression and anxiety, with effect sizes greater than 1.0 and percentage changes between 32.4% and 40%.

High completion rates and patient satisfaction indicate that iCBT could be an effective and accessible treatment option for managing the depressed phase of bipolar disorder, addressing the gap in the use of evidence-based psychological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet delivered cognitive behaviour therapy provided as routine care for people in the depressed phase of bipolar disorder treated with Lithium. Nielssen, O., Staples, L., Karin, E., et al.[2023]

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]

Cognitive behavior therapy (CBT) has been shown to be effective as an adjunctive treatment for bipolar disorders, improving both symptomatic and functional outcomes compared to standard medical treatment, based on a review of four controlled trials.

Despite the positive findings, further research is needed to understand the long-term stability of CBT's effects and its differential impact on manic versus depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy as supplement to pharmacotherapy of manic depressive disorders. What is the empirical basis?]. Meyer, TD., Hautzinger, M.[2019]

Cognitive-behavioral therapy (CBT) shows promise as an effective adjunctive treatment for bipolar disorder (BD), potentially improving patient compliance with medication, quality of life, and early symptom recognition.

Preliminary results suggest that CBT may help reduce relapse rates and depressive symptoms in BD, but more rigorous randomized clinical trials are necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy: applications for the management of bipolar disorder. Patelis-Siotis, I.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A web-based self-management intervention for Bipolar Disorder 'living with bipolar': a feasibility randomised controlled trial. [2022]

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

An internet-delivered self-management programme for bipolar disorder in mental health services in Ireland: Results and learnings from a feasibility trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-based psychological interventions for bipolar disorder: Review of the present and insights into the future. [2022]

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

Effectiveness of internet delivered cognitive behaviour therapy provided as routine care for people in the depressed phase of bipolar disorder treated with Lithium. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy as supplement to pharmacotherapy of manic depressive disorders. What is the empirical basis?]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Cognitive therapy as an adjunct to medication in bipolar disorder. [2019]

9. Denmark pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy: applications for the management of bipolar disorder. [2019]