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e-CBT for Bipolar Disorder

Kingston, Canada

N/A

Recruiting

Led By Nazanin Alavi

Research Sponsored by Dr. Nazanin Alavi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6, week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the feasibility and effectiveness of e-CBT for treating patients with bipolar II disorder who have residual depressive symptoms.

See full description

Who is the study for?

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.

What is being tested?

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.See study design

What are the potential side effects?

Since e-CBT is a non-medical therapy focusing on mental health exercises and communication with therapists online, it does not have traditional side effects like medications do; however, participants may experience emotional discomfort addressing psychological issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M)

Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)

Change in symptoms (Young Mania Rating Scale - YMRS)

Secondary study objectives

Differences in personal, social, and cultural factors impacting accessibility to treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: e-CBTExperimental Treatment1 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 UsualActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-CBT

2021

N/A

~300

Do I qualify?Apply below to find out