Recruiting

Electronic CBT

Sponsor:

Dr. Nazanin Alavi

Code:

NCT04664257

Conditions

Bipolar Disorder

Bipolar Depression

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

e-CBT

Study Details

Brief 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.

Conditions

Bipolar Disorder

Bipolar Depression

Study ID

NCT04664257

Start date

Mar 1, 2020

Status verified date

Apr, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Acute hypomanic/manic episodes
  • Acute psychosis
  • Severe alcohol or substance use disorder
  • Active suicidal and/or homicidal ideation
  • Currently receiving/has received CBT in the past year

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.)

Interventions

e-CBT

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

Primary outcome measure

  • Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS) [ Time Frame: Baseline, week 6, week 12 ]
  • Change in symptoms (Young Mania Rating Scale - YMRS) [ Time Frame: Baseline, week 6, week 12 ]
  • Change in symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M) [ Time Frame: Baseline, week 6, week 12 ]

Central Contacts and Locations

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G3

Contacts

More Information

Sponsor

Dr. Nazanin Alavi

Last update posted

Apr 10, 2024

Last verified

Apr, 2024

Keywords

  • Bipolar Disorder
  • Bipolar Depression
  • Cognitive Behavioural Therapy
  • Virtual Mental Health Care
  • Psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Nazanin Alavi on 2024-04-10.