NCT05648175 Comparing Clinical Decision-making of AI Technology to a Multi-professional Care Team in ECBT for Depression

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Diagnosed with MDD by a trained research assistant according to the criteria outlined in the DSM-5 * Ability to provide informed consent * Ability to speak and read English * Having consistent and reliable access to the internet Exclusion Criteria: * Active psychosis * Acute mania * Severe alcohol, or substance use disorder * Active suicidal or homicidal ideation * Currently receiving psychotherapy

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