NCT07783633

Brief Summary

The proposed study will be a single-arm pragmatic clinical trial examining the feasibility of online CBT within the CAN-BIND sites and the biomarkers of treatment response to online CBT for mood disorders.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jul 2029

Study Start

First participant enrolled

July 28, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2029

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 21, 2026

Last Update Submit

August 25, 2026

Conditions

Depression / Major Depressive DisorderBipolar Disorder (BD)

Keywords

Cognitive behavioral therapyOnline treatment

Outcome Measures

Primary Outcomes (1)

  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    A widely used and well-validated, 16-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.

    Baseline, Week 8, Week 16, Week 24, Week 32

Secondary Outcomes (8)

  • Patient Health Questionnaire - 9 (PHQ-9)

    Baseline, Week 8, Week 16, Week 24, Week 32

  • Generalized Anxiety Disorder - 7 (GAD-7)

    Baseline, Week 8, Week 16, Week 24, Week 32

  • Snaith-Hamilton Pleasure Scale (SHAPS)

    Baseline, Week 8, Week 16, Week 24, Week 32

  • Work and Social Adjustment Scale (WSAS)

    Baseline, Week 8, Week 16, Week 24, Week 32

  • The World Health Organization-Five Well-Being Index (WHO-5)

    Baseline, Week 8, Week 16, Week 24, Week 32

  • +3 more secondary outcomes

Study Arms (1)

Online Cognitive Behavioral Therapy

EXPERIMENTAL

The Wellbeing Course is an online intervention offered through the Online Therapy Unit to support people dealing with mood disorders. The course consists of 5 core lessons that provides psychoeducation on effective cognitive behavioural techniques for managing symptoms of depression and/or anxiety with short video overviews, client stories and interactive exercises. Participants will engage with the course for 8-weeks during the intervention period but will receive access for 1-year. Participants will also complete study assessments after the intervention period and then bimonthly assessments during the follow-up phase.

Behavioral: Online Cognitive Behavioural Therapy

Interventions

Online Cognitive Behavioural TherapyBEHAVIORAL

The Wellbeing course is an online program that educates and guides users in cognitive behavioural therapy techniques with downloadable guides, client stories and interactive exercises to help manage symptoms of mood concerns.

Also known as: Wellbeing Course
Online Cognitive Behavioral Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be deemed to have capacity to provide informed consent;
  • Must sign and date the informed consent form;
  • Stated willingness to comply with all study procedures;
  • years of age or older;
  • Fluency in English;
  • Meet lifetime criteria for a bipolar or depressive disorder as defined by the DSM-5 and assessed in a previous CAN-BIND study;
  • Consent to the linkage of data to the previous CAN-BIND study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H1, Canada

Location

Related Links

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Lena C. Lena, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

July 28, 2029

Study Completion (Estimated)

July 28, 2029

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

This study is funded by Ontario Brain Institue (OBI). Data collected during the duration of the study will be entered into a database known as "Brain-CODE", which is an open-access database with high level security protocols that allows for the sharing of coded data with other researchers in Canada or around the world.

Shared Documents
STUDY PROTOCOL
Time Frame
Within 12 months of study completion
Access Criteria
Access to IPD and supporting information is through submission of a detailed research analysis proposal that will be reviewed by Ontario Brain Institute (OBI) and the executive committees of Canadian Biomarker Integration Network in Depression (CAN-BIND). For researchers outside Canada or not affiliated with CAN-BIND, they will need to establish a Data Use Agreement with OBI before they can access any data from CAN-BIND.
More information

Locations

CA(1)