Incorporating Stepped Care Approach Into e-CBT for Depression

NCT04747873 | Completed

• 1 other identifier: PSYC-247-21
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Major Depressive Disorder; Depressive Symptoms

Keywords

Mental Health; Psychotherapy; Depression; Cognitive Behavioural Therapy; Electronic; Internet

Outcome Measures

Primary Outcomes (3)

• Change in symptoms (Participant Health Questionnaire - 9 Item)

  Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

  Week 3, 6, 9, 12

• Change in symptoms (Quick Inventory of Depressive Symptoms)

  Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

  Week 1

• Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)

  Clinical standardized symptom questionnaire. Scale of 1-5, 1 being the worst.

  Week 1, 6, 12

Study Arms (2)

e-CBT

EXPERIMENTAL

12 weekly sessions with approximately 30 slides and interactive content, delivered through OPTT designed to mirror in-person standard CBT. Participants go through the content and complete homework at the end of the session. Homework is submitted through OPTT and reviewed by the therapist assigned to the participant, who will provide personalized feedback within three days of submission. Therapists have access to pre-designed session-specific feedback templates to use as a basic structure to write their feedback. By doing so, the time needed to respond to each patient is reduced and therefore the number of patients each therapist can handle increases. On average, developing this feedback takes a therapist 15-20 minutes per patient. In addition to the weekly feedback, participants have the option to message their therapist through the platform throughout the week regarding any questions or concerns they may have.

Behavioral: e-CBT

e-CBT + Stepped Care

EXPERIMENTAL

1 - Participant will receive message from assigned care provider on OPTT who check-in with them about strategies and techniques they have discussed and remind them of weekly homework due date. 2.- Participant will receive phone call from therapist who will check-in on them, remind them of therapy strategies, and verbally remind them of weekly homework due date. 3 - Participant will receive phone call from assigned care provider who will check-in on them, remind them of some therapy strategies and techniques and weekly session due date, and provide CBT summary of previously reviewed CBT concepts. 4 - articipant will receive video call (Microsoft Teams) from their therapist who will check-in on them, remind them of weekly session due date, and provide CBT content support to participant. 5 - Participant will receive CBT sessions in live video call (Microsoft Teams) with research psychiatrist involved in care.

Behavioral: e-CBT; Behavioral: Stepped Care

Interventions

e-CBT BEHAVIORAL

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.

e-CBT; e-CBT + Stepped Care

Stepped Care BEHAVIORAL

Stepped care procedure (see arm/group descriptions).

e-CBT + Stepped Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years at the start of the study
• Diagnosis of major depressive disorder according to DSM-5 criteria
• Competence to consent and participate
• Ability to speak and read English
• Consistent and reliable access to the internet

You may not qualify if:

• Active psychosis
• Acute mania
• Severe alcohol or substance use disorder
• Active suicidal or homicidal ideation
• Currently receiving another form of psychotherapy

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (2)

• Stephenson C, Jagayat J, Kumar A, Khamooshi P, Eadie J, Pannu A, Meartsi D, Danaee E, Gutierrez G, Khan F, Gizzarelli T, Patel C, Moghimi E, Yang M, Shirazi A, Omrani M, Patel A, Alavi N. Comparing clinical decision-making of AI technology to a multi-professional care team in an electronic cognitive behavioural therapy program for depression: protocol. Front Psychiatry. 2023 Dec 21;14:1220607. doi: 10.3389/fpsyt.2023.1220607. eCollection 2023.

  PMID: 38188047 DERIVED

• Jagayat JK, Kumar A, Shao Y, Pannu A, Patel C, Shirazi A, Omrani M, Alavi N. Incorporating a Stepped Care Approach Into Internet-Based Cognitive Behavioral Therapy for Depression: Randomized Controlled Trial. JMIR Ment Health. 2024 Feb 9;11:e51704. doi: 10.2196/51704.

  PMID: 38173167 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction

Study Officials

• Nazanin Alavi, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told if they are in a stepped care approach or not. They will all be participating in the same e-CBT modules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Participants will be randomized into 2 groups. One group will be given 12 weeks of e-CBT for depression. The other group will be given the same 12 weeks of e-CBT modules along with the possibility of additional attention if deemed necessary by the therapist.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: April 7, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We plan to publish our protocol and statistical analysis plan during the course of the study.
• Access Criteria: Participant identification information will always be kept confidential and only anonymized data will be used for the publication of results.

Locations

CA (1)