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Incorporating Stepped Care Approach Into e-CBT for Depression

NCT04747873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-04-10

No results posted yet for this study

Summary

This randomized trial intervention will provide e-CBT for MDD through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants (age: 18-65 years) will be offered an e-CBT program tailored to MDD over 12 weeks to address their depressive symptoms. Participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. The content of the e-CBT modules is designed to mirror in-person standard CBT for MDD. There will be 12 weekly sessions that include approximately 30 slides each along with interactive content, delivered through OPTT. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be evaluated. Both groups will receive the 12-week e-CBT program with one group receiving the standard program. In the second arm, a stepped care approach can be implemented if deemed necessary by the care provider. This decision will be made if the participant has not shown improvement. Questionnaire data along with physiological data will be used to determine the decision.

Conditions

Interventions

BEHAVIORAL

e-CBT

The focus of the sessions is placed on the connection between thoughts, behaviours, emotions, physical reactions, and the environment. We work on evaluating negative beliefs and thought processes and their relationship with depression. Our goal is to adjust the negative thinking so that participants can think about and adapt to the things that are happening to them. This allows them to adjust the way they behave and think about their problems in a way that is not as negative and replaces those thoughts and behaviours with potentially more realistic and productive ones. Participants will be offered e-CBT program over 12 weeks with approximately 30 slides in each module. Participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform.

BEHAVIORAL

Stepped Care

Stepped care procedure (see arm/group descriptions).

Sponsors & Collaborators

  • Dr. Nazanin Alavi

    lead OTHER

Principal Investigators

  • Nazanin Alavi, MD, FRCPC · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2023-07-19
Completion
2023-07-19

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747873 on ClinicalTrials.gov