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

NCT04664257 | Recruiting

• 1 other identifier: PHRY-057-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  Clinically validated symptom questionnaire. Scale of 1-6, 6 is worse.

  Baseline, week 6, week 12

• Change in symptoms (Young Mania Rating Scale - YMRS)

  Clinically validated symptom questionnaire. Scale of 1-4 and 1-8, higher is worse.

  Baseline, week 6, week 12

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

  Clinically validated symptom questionnaire. Scale of 1-7 and 1-8, higher is worse.

  Baseline, week 6, week 12

Secondary Outcomes (1)

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

  Week 12 (Post-Treatment)

Study Arms (2)

e-CBT

EXPERIMENTAL

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.

Behavioral: e-CBT

Treatment as Usual

NO INTERVENTION

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

Interventions

e-CBT BEHAVIORAL

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

e-CBT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

RECRUITING

Related Publications (1)

• Gutierrez G, Stephenson C, Eadie J, Moghimi E, Omrani M, Groll D, Soares CN, Milev R, Vazquez G, Yang M, Alavi N. Evaluating the Efficacy of Web-Based Cognitive Behavioral Therapy for the Treatment of Patients With Bipolar II Disorder and Residual Depressive Symptoms: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 May 19;12:e46157. doi: 10.2196/46157.

  PMID: 37140460 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Nazanin Alavi

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazanin Alavi

CONTACT

613 544 4900; nazanin.alavitabari@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Randomly assigned to intervention or control

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CA (1)