Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Diagnosis of Bipolar Disorder - 2

• MADRS score of 7-34

• Competence to consent and participate

• Ability to speak and read English

• Consistent and reliable access to the internet

Locations
Other Locations
Canada
Hotel Dieu Hospital
RECRUITING
Kingston
Contact Information
Primary
Nazanin Alavi
nazanin.alavitabari@kingstonhsc.ca
613 544 4900
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 80
Treatments
Experimental: e-CBT
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.
No_intervention: Treatment as Usual
Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.)
Related Therapeutic Areas
Sponsors
Collaborators: Online PsychoTherapy Clinic
Leads: Dr. Nazanin Alavi

This content was sourced from clinicaltrials.gov

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