What side effects are associated with this type of intervention?

Common treatments for depression include electronic cognitive behavioral therapy (e-CBT) and pharmacotherapy. e-CBT, a digital form of CBT, generally has fewer side effects, but some patients may experience temporary increases in anxiety or emotional distress as they confront challenging thoughts and behaviors. Pharmacotherapy, particularly with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), can cause side effects such as nausea, weight gain, sexual dysfunction, insomnia, and increased risk of suicidal thoughts, especially in young adults. Combining e-CBT with pharmacotherapy may mitigate some side effects by allowing lower doses of medication.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, including pharmacotherapy and psychotherapy. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and citalopram are commonly prescribed antidepressants. Cognitive-behavioral therapy (CBT) is a widely recognized psychotherapy approach. The combination of pharmacotherapy and psychotherapy, such as CBT with antidepressants, has also been validated for treating depression. These treatments align with the modalities being studied in the trial, which includes e-CBT, e-CBT with therapist interaction, and e-CBT with pharmacotherapy.

What other types of research exist?

Promising, novel alternatives to AI technology for care allocation in depression treatment include: 1) Multi-professional care teams that use comprehensive assessments to determine the appropriate intensity of e-CBT. 2) Telemedicine, which allows for remote delivery of CBT with varying levels of therapist interaction. 3) Group CBT sessions, which can provide peer support and reduce feelings of isolation. 4) Internet-based CBT programs that offer flexibility and accessibility. These methods can be tailored to individual patient needs and preferences, potentially improving treatment adherence and outcomes.

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Artificial Intelligence

eCBT Plus vs Multi-professional Care Team for Depression

N/A

Recruiting

Led By Nazanin Alavi, MD FRCPC

Research Sponsored by Dr. Nazanin Alavi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up.

Awards & highlights

Summary

This trial tests an online therapy called e-CBT for people with depression. It compares the effectiveness of AI versus a healthcare team in deciding the level of care needed. The goal is to find a cost-effective way to reduce depression symptoms and improve treatment adherence. Internet-based cognitive behavioral therapy (ICBT) has been shown to be effective in treating depression in several studies.

Who is the study for?

This trial is for individuals diagnosed with Major Depressive Disorder (MDD) as per DSM-5, who can consent, speak and read English, and have reliable internet access. It excludes those currently in psychotherapy, experiencing psychosis or acute mania, having thoughts of suicide or homicide, or severe substance abuse issues.

What is being tested?

The study compares AI decision-making to a multi-professional team's approach in assigning care levels for e-CBT treatment of depression. Participants will be randomly placed into groups receiving different intensities of e-CBT: alone; with calls; or with medication.

What are the potential side effects?

While the trial primarily involves non-invasive e-CBT therapy which may not have direct side effects like medications do, potential indirect side effects could include discomfort from discussing personal issues online and possible privacy concerns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 4, 7, 10, 13, and 3, 6, and 12-month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Assessment of Quality of Life (AQoL-8D) Score

Change in Patient Health Questionnaire (PHQ-9) Score

Change in Quick Inventory of Depressive Symptoms (QIDS) Score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Artificial Intelligence AllocationExperimental Treatment3 Interventions

Allocation of treatment intensity by the proposed AI algorithm will be based on the machine learning and natural language processing (NLP) of textual data provided by participants and their PHQ-9 score collected through a pre-treatment screening module called the Triage Module. This module, developed by the research team, (1) provides psychoeducation on the effects of psychotherapy, (2) collects PHQ-9 scores, and (3) asks participants six open-ended questions regarding their mental health history, their experiences with mental health disorders, and what mental health difficulties they are currently facing. Based on the participant's answers to the open-ended questions, a variable called "Symptomatic Score" will be calculated using the NLP algorithm.

Group II: Healthcare Team AllocationActive Control3 Interventions

Allocation of treatment intensity by the multi-professional healthcare team will be based on the following criteria: 1. The severity of MDD symptoms (using DSM-5 criteria). 2. Mental health factors (prior treatments and responses, current and past psychotic/manic episodes, current and past suicidal/homicidal ideation/attempts, family mental health history, past psychiatric history, and hospital admissions). 3. Medical factors (current medical conditions and medications, personal and family medical history). 4. Social factors (support system and living situation, and occupational, social, and personal functional impairment).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-CBT

2021

N/A

~200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for depression include cognitive-behavioral therapy (CBT), electronic cognitive-behavioral therapy (e-CBT), pharmacotherapy, and electroconvulsive therapy (ECT). CBT and e-CBT work by addressing distorted cognitions and improving social and emotional functioning through structured, goal-oriented therapy sessions, which can be delivered in-person or online. Pharmacotherapy, involving antidepressants like SSRIs, works by altering neurotransmitter levels in the brain to improve mood and emotional state. ECT involves inducing controlled seizures to cause changes in brain chemistry that can rapidly alleviate severe depressive symptoms. Understanding these mechanisms is crucial for depression patients as it helps tailor treatment plans to individual needs, potentially improving adherence and outcomes.

Toward the Design of Evidence-Based Mental Health Information Systems for People With Depression: A Systematic Literature Review and Meta-Analysis.

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Who is running the clinical trial?

Dr. Nazanin AlaviLead Sponsor

12 Previous Clinical Trials

930 Total Patients Enrolled

5 Trials studying Depression

388 Patients Enrolled for Depression

Queen's UniversityLead Sponsor

371 Previous Clinical Trials

123,752 Total Patients Enrolled

32 Trials studying Depression

6,967 Patients Enrolled for Depression

Nazanin Alavi, MD FRCPCPrincipal Investigatornazanin.alavitabari@kingstonhsc.ca

2 Previous Clinical Trials

170 Total Patients Enrolled

1 Trials studying Depression

110 Patients Enrolled for Depression

Media Library

AI Technology (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT05648175 — N/A

Depression Research Study Groups: Artificial Intelligence Allocation, Healthcare Team Allocation

Depression Clinical Trial 2023: AI Technology Highlights & Side Effects. Trial Name: NCT05648175 — N/A

AI Technology (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05648175 — N/A

~15 spots leftby Dec 2024

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