RecruitingNot ApplicableNCT04664257

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


Sponsor

Dr. Nazanin Alavi

Enrollment

80 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online Cognitive Behavioural Therapy (CBT) program for people with Bipolar II Disorder who still have mild to moderate depression symptoms. Researchers want to see if digital therapy delivered over the internet can help reduce those lingering depressive feelings. **You may be eligible if you:** - Have been diagnosed with Bipolar II Disorder - Have mild to moderate depression symptoms (as measured by a standard depression scale) - Can read and speak English - Have reliable internet access - Are able to give informed consent to participate **You may NOT be eligible if you:** - Are currently experiencing a manic or hypomanic episode - Are experiencing active psychosis - Have a severe alcohol or substance use disorder - Have active thoughts of suicide or harming others - Are currently receiving CBT or have received it in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALe-CBT

e-CBT will be administered with weekly modules. See arm/group descriptions for more information.


Locations(1)

Hotel Dieu Hospital

Kingston, Ontario, Canada

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NCT04664257


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