Comparing e-CBT with e-CBT + Phone Call for depression
Official title: Comparing Clinical Decision-making of AI Technology to a Multi-professional Care Team in ECBT for Depression
Comparing Clinical Decision-making of AI Technology to a Multi-professional Care Team in an Electronic Cognitive Behavioural Therapy Program for Depression
Interventions
e-CBT
The participant will submit their weekly homework and receive personalized feedback from their assigned therapist on OPTT. The feedback adds customization by acknowledging the participant's experiences in the past week and ensures the participant has understood the CBT concepts.
e-CBT + Phone Call
In addition to the e-CBT program (see 1 above), the participant will receive a weekly phone/video call from their assigned therapist. The goal is to build on the therapeutic relationship and to add personalization with direct verbal encouragement. This phone/video call is limited to a one-time, 15-20 minutes call each intervention week.44 The purpose is to check with the patient on their treatment progress. The secure call will either be a phone or video (via Microsoft Teams) call, depending on the preference of the patient.
e-CBT + Phone Call + Pharmacotherapy
In addition to the e-CBT program (see 1 above), the participant will receive standard pharmacotherapy following DSM-5 guidelines. A pharmacotherapy allocation system has been developed (Figure 1; Figure 2) that follows clinical guidelines. All medications will be prescribed by a psychiatrist on the research team. All medications are a part of the clinical standard of care. The medications will be provided to the participant through the normal process of receiving medication (i.e., pharmacy). Participants allocated to the e-CBT + Phone Call + Pharmacotherapy arm will begin the pharmacotherapy optimization process at the same time as they begin the e-CBT program. Oversight of medication in the e-CBT + Pharmacotherapy arm will be conducted by a psychiatrist on the team who will make a judgement regarding whether to alter the medications. This will not require any additional study visits/time commitment for the participants in this arm.
Canadian Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Diagnosed with MDD by a trained research assistant according to the criteria outlined in the DSM-5
- +Ability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Ability to speak and read English
- +Having consistent and reliable access to the internet
Exclusion
- −Active psychosis
- −Acute mania
- −Severe alcohol, or substance use disorder
- −Active suicidal or homicidal ideation
- −Currently receiving psychotherapy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: e-CBT, e-CBT + Phone Call, e-CBT + Phone Call + Pharmacotherapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 186 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Patient Health Questionnaire (PHQ-9) Score — measured over week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Change in Quick Inventory of Depressive Symptoms (QIDS) Score — measured over week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up.
Change in Assessment of Quality of Life (AQoL-8D) Score — measured over week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05648175 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About e-CBTBehavioural
The participant will submit their weekly homework and receive personalized feedback from their assigned therapist on OPTT. The feedback adds customization by acknowledging the participant's experiences in the past week and ensures the participant has understood the CBT concepts.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About e-CBT + Phone CallBehavioural
In addition to the e-CBT program (see 1 above), the participant will receive a weekly phone/video call from their assigned therapist. The goal is to build on the therapeutic relationship and to add personalization with direct verbal encouragement. This phone/video call is limited to a one-time, 15-20 minutes call each intervention week.44 The purpose is to check with the patient on their treatment progress. The secure call will either be a phone or video (via Microsoft Teams) call, depending on the preference of the patient.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About e-CBT + Phone Call + PharmacotherapyBehavioural
In addition to the e-CBT program (see 1 above), the participant will receive standard pharmacotherapy following DSM-5 guidelines. A pharmacotherapy allocation system has been developed (Figure 1; Figure 2) that follows clinical guidelines. All medications will be prescribed by a psychiatrist on the research team. All medications are a part of the clinical standard of care. The medications will be provided to the participant through the normal process of receiving medication (i.e., pharmacy). Participants allocated to the e-CBT + Phone Call + Pharmacotherapy arm will begin the pharmacotherapy optimization process at the same time as they begin the e-CBT program. Oversight of medication in the e-CBT + Pharmacotherapy arm will be conducted by a psychiatrist on the team who will make a judgement regarding whether to alter the medications. This will not require any additional study visits/time commitment for the participants in this arm.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →..
The study as a whole is currently expected to finish around 2025-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 186 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Kingston, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Depression is a leading cause of disability worldwide, affecting up to 300 million people globally. Despite its high prevalence and debilitating effects, only one-third of patients newly diagnosed with depression initiate treatment. Electronic cognitive behavioural therapy (e-CBT) is an effective treatment for depression and is a feasible solution to make mental health care more accessible. Due to its online format, e-CBT can be combined with variable therapist engagement to address different care needs. Typically, a multi-professional care team determines which combination therapy is the most beneficial to the patient. However, this process can add to the costs of these programs. Artificial intelligence (AI) technology has been proposed to offset these costs. Therefore, this study aims to determine a cost-effective method to decrease depressive symptoms and increase treatment adherence to e-CBT. This will be done by comparing AI technology to a multi-professional care team when allocating the correct intensity of care for individuals diagnosed with depression. This study is a double-blinded randomized controlled trial recruiting individuals (n = 186) experiencing depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The degree of care intensity a participant will receive will be randomly decided by either: (1) a machine learning algorithm (n = 93), or (2) an assessment made by a group of healthcare professionals (n = 93). Subsequently, participants will receive depression-specific e-CBT treatment through the secure online platform, OPTT. There will be three available intensities of therapist interaction: (1) e-CBT; (2) e-CBT with a 15-20-minute phone/video call; and (3) e-CBT with pharmacotherapy. This approach aims to accurately allocate care tailored to each patient's needs, allowing for more efficient use of resources.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.