e-CBT for Bipolar Disorder

Overseen By Nazanin Alavi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Nazanin Alavi

Disqualifiers: Acute hypomania, Psychosis, Substance use, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electronic cognitive behavioral therapy (e-CBT) effectively helps individuals with Bipolar II Disorder experiencing depressive symptoms. Conducted online, e-CBT offers easier access to therapy compared to traditional in-person sessions. The study will compare two groups: one receiving e-CBT alongside their usual treatment and another continuing with only their usual treatment. Individuals diagnosed with Bipolar II Disorder, currently in a depressive phase, and with reliable internet access may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to access innovative therapy methods that could enhance mental health.

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 prior data suggests that e-CBT is safe for treating Bipolar Disorder?

Research has shown that electronic Cognitive Behavioral Therapy (e-CBT) is generally easy for patients to manage. Studies have found that e-CBT is as effective as face-to-face CBT in treating depression and anxiety, including for those with bipolar disorder. A review of multiple studies found that e-CBT manages depressive symptoms in bipolar disorder as effectively as other online therapies.

No major reports of serious side effects have emerged from using e-CBT. As a form of talk therapy conducted online, it does not involve medication or physical procedures, reducing the risk of physical side effects. Overall, e-CBT is considered a safe option for mental health treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about e-CBT for Bipolar Disorder because it offers a new, more accessible way to deliver cognitive-behavioral therapy. Unlike traditional in-person CBT, e-CBT is administered online through OPTT, allowing for flexible scheduling and broader reach to patients who might not have easy access to mental health services. The program features engaging multimedia modules and weekly personalized feedback from clinicians, which could streamline the therapy process and make it more efficient. This method not only saves time for healthcare providers but also ensures that patients receive tailored feedback, potentially enhancing the overall effectiveness of the treatment.

What evidence suggests that e-CBT is effective for treating Bipolar Disorder II with depressive symptoms?

Research has shown that electronic cognitive behavioral therapy (e-CBT), which participants in this trial may receive, can effectively manage depression in individuals with Bipolar II Disorder. Studies indicate that e-CBT works as well as face-to-face CBT for treating depression and anxiety, effectively reducing depressive episodes. One study found that e-CBT helps more people adhere to their therapy, which is crucial for those who struggle to attend regular sessions. Overall, e-CBT offers an easier way to access effective mental health care. ^{1 2 3 6 7}

Who Is on the Research Team?

Nazanin Alavi

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• e-CBT

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as e-CBT for:

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

Approved in United States as e-CBT for:

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

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+

Online PsychoTherapy Clinic

Collaborator

Trials

9

Recruited

710+

Published Research Related to This Trial

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-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]

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]

Cognitive behavior therapy (CBT) shows promise as a beneficial adjunct to medication for patients with bipolar disorder, emphasizing a collaborative and educational approach that empowers patients to take an active role in their treatment.

Preliminary studies suggest that CBT may improve outcomes for bipolar disorder, but further randomized controlled trials are necessary to confirm its effectiveness compared to standard treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy as an adjunct to medication in bipolar disorder. Scott, J.[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]

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]

In a study involving 345 participants, including 106 with bipolar disorder, it was found that while emotional imagery quality was similar across groups, the appraisals of imagery significantly differed, particularly between those with and without mood disorders.

Imagery was reported to amplify emotions in all groups, but only individuals with bipolar disorder experienced this amplification as influencing their behavior, especially during manic or depressed states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. van den Berg, KC., Voncken, M., Hendrickson, AT., et al.[2023]

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