search
Back to results

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

Primary Purpose

Bipolar Disorder, Bipolar Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
e-CBT
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Bipolar Depression, Cognitive Behavioural Therapy, Virtual Mental Health Care, Psychotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

e-CBT

Treatment as Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)
Clinically validated symptom questionnaire. Scale of 1-6, 6 is worse.
Change in symptoms (Young Mania Rating Scale - YMRS)
Clinically validated symptom questionnaire. Scale of 1-4 and 1-8, higher is worse.
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.

Secondary Outcome Measures

Differences in personal, social, and cultural factors impacting accessibility to treatment
Focus groups for providers and patients using Interpretive Phenomenological Analysis

Full Information

First Posted
December 5, 2020
Last Updated
October 14, 2022
Sponsor
Queen's University
Collaborators
Online PsychoTherapy Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04664257
Brief Title
Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
Official Title
Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Online PsychoTherapy Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Population: Individuals (n = 80) diagnosed with BAD-II who are experiencing an acute depressive episode will be recruited from the Mood and Anxiety Clinic at Providence Care Hospital (PCH) in Kingston, Ontario, Canada. Inclusion criteria include being between 18 and 55 years of age at the start of the study, a confirmed diagnosis of BAD-II according to Diagnostic and Statistical Manual of Mental Health Disorders, 5th Edition (DSM-5), a Montgomery Åsberg Depression Rating Scale (MADRS) score between 7 and 34, competence to consent and participate, the ability to speak and read English, and having consistent and reliable access to the internet. Exclusion criteria include experiencing a current acute hypomanic/manic episode, acute psychosis, severe alcohol or substance use disorder, and active suicidal and/or homicidal ideation. Additionally, if an individual is currently receiving or has received CBT in the past year they will be excluded from the study. To confirm eligibility, participants will undergo a complete assessment from a clinician where the diagnosis will be confirmed using the DSM-5 and a Mini-International National Interview (MINI) version 7.0.2. Eligible participants will be randomly allocated into either the e-CBT plus treatment as usual (TAU) (n = 40) or the control group (TAU exclusively) (n = 40). Participants in the control group will be offered the e-CBT program after the first 12 weeks of the study if they are interested. Procedure: Upon completion of the initial assessment, if eligible for the study, participants from the e-CBT group will be enrolled in the e-CBT program. 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. To ensure the quality and consistency of care, care pathways will be fully assigned beforehand, and a clinician will be trained to follow the standard care pathways. Through the training, the clinician will learn the aim and content of each therapeutic session and will be provided with sample homework submissions and modules to better understand how to structure feedback.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Bipolar Depression
Keywords
Bipolar Disorder, Bipolar Depression, Cognitive Behavioural Therapy, Virtual Mental Health Care, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomly assigned to intervention or control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
e-CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.)
Intervention Type
Behavioral
Intervention Name(s)
e-CBT
Intervention Description
e-CBT will be administered with weekly modules. See arm/group descriptions for more information.
Primary Outcome Measure Information:
Title
Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)
Description
Clinically validated symptom questionnaire. Scale of 1-6, 6 is worse.
Time Frame
Baseline, week 6, week 12
Title
Change in symptoms (Young Mania Rating Scale - YMRS)
Description
Clinically validated symptom questionnaire. Scale of 1-4 and 1-8, higher is worse.
Time Frame
Baseline, week 6, week 12
Title
Change in symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M)
Description
Clinically validated symptom questionnaire. Scale of 1-7 and 1-8, higher is worse.
Time Frame
Baseline, week 6, week 12
Secondary Outcome Measure Information:
Title
Differences in personal, social, and cultural factors impacting accessibility to treatment
Description
Focus groups for providers and patients using Interpretive Phenomenological Analysis
Time Frame
Week 12 (Post-Treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazanin Alavi
Phone
613 544 4900
Ext
73002
Email
nazanin.alavitabari@kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazanin Alavi
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazanin Alavi
Phone
6479672079
Email
nazanin.alavitabari@kingstonhsc.ca

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs