Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05648175

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

Led by Dr. Nazanin Alavi · Updated on 2024-10-18

186

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Major Depressive Disorder by a trained research assistant using DSM-5 criteria
  • Ability to provide informed consent
  • Ability to speak and read English
  • Having consistent and reliable access to the internet
Not Eligible

You will not qualify if you...

  • Active psychosis
  • Acute mania
  • Severe alcohol or substance use disorder
  • Active suicidal or homicidal thoughts
  • Currently receiving psychotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hotel Dieu Hospital

Kingston, Ontario, Canada, K7L 5G3

Actively Recruiting

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Research Team

N

Nazanin Alavi, MD FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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