Major Depressive DisorderNCT04825535
Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
A study testing Standard psychiatry and cognitive behavioral online intervention and Standard psychiatry and cognitive behavioural in-person intervention in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Standard psychiatry and cognitive behavioral online intervention and Standard psychiatry and cognitive behavioural in-person intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2020to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
- Psychiatrist diagnosis of Major Depression Disorder;
- Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;
- fluent in English.
Who cannot join
- individuals currently receiving weekly structured psychotherapy;
- individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;
- individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);
- individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder
In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.
Read the detailed description
Depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. Cognitive Behavioural Therapy (CBT) is the best-evidenced treatment for depression, but despite demonstrated efficacy, many individuals cannot access adequate psychotherapeutic treatment due to the limitations of face-to-face delivery. In recent years, CBT has been integrated with mindfulness meditation (CBT-M) following strong evidence for increased efficacy when the two modalities are combined. Previous RCTs have demonstrated that online CBT-M is effective in depressive symptom reduction, but direct comparisons to in-office CBT delivery assessing cost and treatment outcomes are required to facilitate innovation and clinical policy change.
Objectives: To assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults diagnosed with major depressive disorder (MDD). The study will assess whether digitally recorded adherence data (i.e. online workbooks completed, Fitbit tracked step count, online text-messages exchanged, phone sessions completed) predict outcome benefits in the online-group participants as measured by changes in depressive symptoms.
Methods: This single-centre, 2-arm non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.
The research site is the Centre for Addiction and Mental Health (CAMH), a large research-based psychiatry institution located in Toronto, Canada. Participants will be identified from wait-lists for CAMH services and through contacts with other Toronto outpatient clinics.
Interventions: All participants will receive standard psychiatric care (1 pharmacotherapy focused visit/month with a psychiatrist of 15-30 minute duration). Experimental participants additionally receive online CBT-M while control participants receive standard care in-office group CBT-M. The online group CBT-M program (in collaboration with NexJ Health, Inc.) combines exposure to smartphone and computer accessed workbooks with phone-based mental health counselling (16 hours in 16 weeks) that coordinates with ongoing software interactions (e.g. secure text messaging, Fitbit tracked walking). Each participant is loaned a Fitbit-HR Charge 3 to assess physical activity as measured by daily step count.
- Conditions
- Major Depressive Disorder
- Being tested
- Standard psychiatry and cognitive behavioral online intervention, Standard psychiatry and cognitive behavioural in-person intervention
- Keywords
- internet-based intervention, major depressive disorder, health coaching
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard psychiatry and cognitive behavioral online interventionBehavioural
The cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380
Standard psychiatry and cognitive behavioural in-person interventionBehavioural
The effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% [3,18 ]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) [41]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration.
| Study group | Role | What they receive |
|---|---|---|
| Standard psychiatry and cognitive behavioural online intervention | Experimental | The online group CBT-M program combines software-based workbooks with phone-based Navigator-Coaching that coordinates software interactions (e.g., secure text messaging, Fitbit tracked walking, food monitoring via photography). Navigation coaching is supplied by students who were pursuing graduate degrees (MSc, MA, PhD) in kinesiology and health science, education, and psychology. Receives: Behavioral: Standard psychiatry and cognitive behavioral online intervention |
| Standard psychiatry and cognitive behavioural in-person intervention | Active comparator | The on-site, usual-care CBT group follows the structure of the Mind Over Mood workbook in reviewing CBT concepts and procedures. A series of work sheets assist participants in differentiating moods, and in differentiating moods from thoughts and situational influences, leading to modifications of thinking, behaviour, emotion and mood. Group leaders are standard leaders in the CAMH group-CBT program who have Masters-level degrees in psychology, social work and occupational therapists. Receives: Behavioral: Standard psychiatry and cognitive behavioural in-person intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)
Frequently used and validated self report measure
Measured: Baseline and 4 months
Secondary outcomes (6)
Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)
Frequently used and validated self report measure
Measured: Baseline and 4 months
Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)
Frequently used and validated self report measure
Measured: Baseline and 4 months
Change in Hamilton Depression Rating Scale - 24-item version (0 to 72) Hamilton Depression Rating Scale - 24 item (0 - 96 - higher score indicates worse outcome)
Frequently used and validated interview-based evaluation instrument
Measured: Baseline and 4 months
Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire
Frequently used and validated self report measure
Measured: Baseline and 4 months
Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)
Frequently used and validated self report measure
Measured: Baseline and 4 months
Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)
Frequently used and validated self report measure
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Dec 2020
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Why it stopped: Study closed prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Online CBT intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Gratzer, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825535
- Sponsor's protocol ID
- 08-2020
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. We may consider investigators who wish to use data in further analyses but we cannot guarantee access.
Publications
Ritvo P, Gratzer D, Knyahnytska Y, Ortiz A, Walters C, Katz J, Laposa J, Baldissera C, Wayne N, Pfefer-Litman D, Tomlinson G, Daskalakis Z. Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 8;11(4):e29726. doi: 10.2196/29726.
PubMed 35393942
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04825535
- Acronym / sponsor ID
- 08-2020
- Conditions
- Major Depressive Disorder
- Keywords
- internet-based intervention, major depressive disorder, health coaching
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed prematurely
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 1 Apr 2021 (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.
In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.
Detailed description
Depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. Cognitive Behavioural Therapy (CBT) is the best-evidenced treatment for depression, but despite demonstrated efficacy, many individuals cannot access adequate psychotherapeutic treatment due to the limitations of face-to-face delivery. In recent years, CBT has been integrated with mindfulness meditation (CBT-M) following strong evidence for increased efficacy when the two modalities are combined. Previous RCTs have demonstrated that online CBT-M is effective in depressive symptom reduction, but direct comparisons to in-office CBT delivery assessing cost and treatment outcomes are required to facilitate innovation and clinical policy change.
Objectives: To assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults diagnosed with major depressive disorder (MDD). The study will assess whether digitally recorded adherence data (i.e. online workbooks completed, Fitbit tracked step count, online text-messages exchanged, phone sessions completed) predict outcome benefits in the online-group participants as measured by changes in depressive symptoms.
Methods: This single-centre, 2-arm non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.
The research site is the Centre for Addiction and Mental Health (CAMH), a large research-based psychiatry institution located in Toronto, Canada. Participants will be identified from wait-lists for CAMH services and through contacts with other Toronto outpatient clinics.
Interventions: All participants will receive standard psychiatric care (1 pharmacotherapy focused visit/month with a psychiatrist of 15-30 minute duration). Experimental participants additionally receive online CBT-M while control participants receive standard care in-office group CBT-M. The online group CBT-M program (in collaboration with NexJ Health, Inc.) combines exposure to smartphone and computer accessed workbooks with phone-based mental health counselling (16 hours in 16 weeks) that coordinates with ongoing software interactions (e.g. secure text messaging, Fitbit tracked walking). Each participant is loaned a Fitbit-HR Charge 3 to assess physical activity as measured by daily step count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Online CBT intervention
| Arm | Type | Receives |
|---|---|---|
| Standard psychiatry and cognitive behavioural online intervention | Experimental | Behavioral: Standard psychiatry and cognitive behavioral online interventionThe online group CBT-M program combines software-based workbooks with phone-based Navigator-Coaching that coordinates software interactions (e.g., secure text messaging, Fitbit tracked walking, food monitoring via photography). Navigation coaching is supplied by students who were pursuing graduate degrees (MSc, MA, PhD) in kinesiology and health science, education, and psychology. |
| Standard psychiatry and cognitive behavioural in-person intervention | Active comparator | Behavioral: Standard psychiatry and cognitive behavioural in-person interventionThe on-site, usual-care CBT group follows the structure of the Mind Over Mood workbook in reviewing CBT concepts and procedures. A series of work sheets assist participants in differentiating moods, and in differentiating moods from thoughts and situational influences, leading to modifications of thinking, behaviour, emotion and mood. Group leaders are standard leaders in the CAMH group-CBT program who have Masters-level degrees in psychology, social work and occupational therapists. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
- Psychiatrist diagnosis of Major Depression Disorder;
- Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;
- fluent in English.
Key exclusion criteria (4 listed)
- individuals currently receiving weekly structured psychotherapy;
- individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;
- individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);
- individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode
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 |
|---|---|---|
| Standard psychiatry and cognitive behavioral online interventionThe cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380 | Behavioural | Standard psychiatry and cognitive behavioural online intervention |
| Standard psychiatry and cognitive behavioural in-person interventionThe effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% [3,18 ]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) [41]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration. | Behavioural | Standard psychiatry and cognitive behavioural in-person intervention |
Primary outcome
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)
Time frame: Baseline and 4 months
Frequently used and validated self report measure
6 secondary outcomes
Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)
Time frame: Baseline and 4 months
Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)
Time frame: Baseline and 4 months
Change in Hamilton Depression Rating Scale - 24-item version (0 to 72) Hamilton Depression Rating Scale - 24 item (0 - 96 - higher score indicates worse outcome)
Time frame: Baseline and 4 months
Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire
Time frame: Baseline and 4 months
Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)
Time frame: Baseline and 4 months
Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)
Time frame: Baseline and 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 35393942Ritvo P, Gratzer D, Knyahnytska Y, Ortiz A, Walters C, Katz J, Laposa J, Baldissera C, Wayne N, Pfefer-Litman D, Tomlinson G, Daskalakis Z. Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 8;11(4):e29726. doi: 10.2196/29726.
- Individual participant dataSharing planned: No. No. We may consider investigators who wish to use data in further analyses but we cannot guarantee access.
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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. This study is not recruiting at the moment.
David Gratzer, MD 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 Standard psychiatry and cognitive behavioral online intervention and Standard psychiatry and cognitive behavioural in-person intervention in people with Major Depressive Disorder, 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 Apr 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome) (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825535, which also lists 1 linked publication.
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 7 Apr 2026.