Depression / Major Depressive DisorderCAN-BIND-iCBTNCT07783633
Identifying Biomarkers of Response to Digital Interventions for Mood Disorders
A study testing Online Cognitive Behavioural Therapy in people with Depression / Major Depressive Disorder and Bipolar Disorder (BD), run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Depression / Major Depressive Disorder, Bipolar Disorder (BD)
- What is being tested?
- Online Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2026to 28 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- 16 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
Who cannot join
- 1. Exclusion criteria for the current study include not meeting inclusion criteria only
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H1
About this study
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.
Read the detailed description
A total of 200 participants from the Canadian Biomarker Integration Network in Depression (CAN-BIND) network research sites will receive access to the Wellbeing Course for 8 Weeks with a 6-month follow-up period.
- Being tested
- Online Cognitive Behavioural Therapy
- Keywords
- Cognitive behavioral therapy, Online treatment
- Medical subject headings
- Depression, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive Behavioural TherapyBehavioural
Also called Wellbeing Course
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Secondary outcomes (8)
Patient Health Questionnaire - 9 (PHQ-9)
A widely used and well-validated, 9-item measure of depression symptoms. Minimum score is 0 and Maximum score is 27, with higher scores indicating severe depression.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Generalized Anxiety Disorder - 7 (GAD-7)
A widely used and well-validated, 7-item measure of symptoms of anxiety. Minimum score is 0 and Maximum score is 21, with higher scores indicating severe anxiety.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Snaith-Hamilton Pleasure Scale (SHAPS)
A widely used and well-validated 14-item measure of the ability to experience pleasure. Minimum score is 0 and Maximum score is 14, with higher scores indicating greater pleasure.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Work and Social Adjustment Scale (WSAS)
A 5-item measure of the impact of mental health conditions on daily functioning. Minimum score is 0 and Maximum score is 40, with higher scores indicating greater impairment in overall functioning.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
The World Health Organization-Five Well-Being Index (WHO-5)
A 5-item short form of quality of life across multiple domains. Raw scores range from 0 to 25 and can be converted to a percentage score ranging from 0 to 100, with higher scores indicating better mental well-being.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Perseverative Thinking Questionnaire (PTQ)
A 15-item measure that assesses the underlying process of repetitive negative thinking, independent of specific thought content or diagnostic category. Minimum score is 0 and Maximum score is 60, with higher score indicating more frequent and intrusive negative thought patterns.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Ruminative Response Scale (RRS) - Brooding Subscale
A 5-item measure of maladaptive rumination. Minimum score is 5 and Maximum score is 20, with higher scores indicating greater brooding.
Measured: Baseline, Week 8, Week 16, Week 24, Week 32
Childhood Experience of Care and Abuse Questionnaire (CECA.Q)
A self-report measure assessing negative childhood experiences before age 17, including Neglect and Abuse. Sub-scale scores are derived by summing relevant items, with established cut-offs for severity of Neglect, Antipathy, Physical and Sexual abuse.
Minimum score for Antipathy or Neglect is 8 and Maximum score is 40. A cutoff of >=25 for severity of Antipathy mother/father while cutoff for severity of Neglect is >=22 for mother and >=24 for father.
Minimum score for severity of Physical abuse is 0 and Maximum score is 4. Minimum score for severity of Sexual abuse is 0 and Maximum score is 7. The cutoff for severity of Physical and Sexual abuse is >=1.
Higher scores across all subscales (Antipathy, Neglect, Physical abuse, Sexual abuse) indicates greater severity.
Loss and Support are also reported in this measure and scored as present or absent. Loss reflects parental death before age 17 or separation of 1+ year while Support reflects presence of at least one support figure.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start28 Jul 2026
- Primary completion28 Jul 2029 (estimated)
- Study completion28 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression / Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute, McMaster University, Queen's University, University of Ottawa, University of British Columbia, University of Calgary, Dalhousie University, University of Michigan, Simon Fraser University, Ontario Shores Centre for Mental Health Sciences, University of Regina, University of Texas Southwestern Medical Center, University Health Network, Toronto, St. Joseph's Healthcare Hamilton, Nova Scotia Health Authority, The Canadian Biomarker Integration Network in Depression
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C. Lena, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783633
- Sponsor's protocol ID
- CAN-BIND-21
- Acronym
- CAN-BIND-iCBT
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers of Response to Digital Interventions for Mood Disorders
- ClinicalTrials.gov ID
- NCT07783633
- Acronym / sponsor ID
- CAN-BIND-iCBT / CAN-BIND-21
- Keywords
- Cognitive behavioral therapy, Online treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Brain Institute, McMaster University, Queen's University, University of Ottawa, University of British Columbia, University of Calgary, Dalhousie University, University of Michigan, Simon Fraser University, Ontario Shores Centre for Mental Health Sciences, University of Regina, University of Texas Southwestern Medical Center, University Health Network, Toronto, St. Joseph's Healthcare Hamilton, Nova Scotia Health Authority, The Canadian Biomarker Integration Network in Depression
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 28 Jul 2029 (estimated)
- Study completion
- 28 Jul 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 200 participants from the Canadian Biomarker Integration Network in Depression (CAN-BIND) network research sites will receive access to the Wellbeing Course for 8 Weeks with a 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Cognitive Behavioral Therapy | Experimental | Behavioral: Online Cognitive Behavioural TherapyThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 16 years of age or older;
- Fluency in English;
Key exclusion criteria (1 listed)
- 1. Exclusion criteria for the current study include not meeting inclusion criteria only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive Behavioural TherapyAlso: Wellbeing CourseThe 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. | Behavioural | Online Cognitive Behavioral Therapy |
Primary outcome
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
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.
8 secondary outcomes
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
The World Health Organization-Five Well-Being Index (WHO-5)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Perseverative Thinking Questionnaire (PTQ)
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Ruminative Response Scale (RRS) - Brooding Subscale
Time frame: Baseline, Week 8, Week 16, Week 24, Week 32
Childhood Experience of Care and Abuse Questionnaire (CECA.Q)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Information about programs, services and research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena C. Lena, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Behavioural Therapy in people with Depression / Major Depressive Disorder and Bipolar Disorder (BD), run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) (time frame: Baseline, Week 8, Week 16, Week 24, Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.