Feasibility and Effectiveness of Delivering CBT Through OPTT for Depression

NCT04478058 | Completed

• 1 other identifier: PSIY-563-17
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Major Depressive Disorder (MDD) is a prevalent and debilitating mental health disorder. Among different therapeutic approaches (e.g., medication, psychotherapy), psychotherapy in the form of cognitive behavioural therapy (CBT) is considered the gold standard treatment for MDD. However, while efficacious, CBT is not readily accessible to many patients in need due to hurdles like stigma, long wait times, high cost, the large time commitment for health care providers, and cultural/geographic barriers. Online delivery of CBT (e-CBT) can effectively address many of these accessibility barriers. Objective: This study aims to investigate the efficacy and feasibility of implementing a digital online psychotherapy clinic for the treatment of MDD. This non-randomized control 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. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared to a group receiving in-person CBT. Questionnaires will be completed at baseline, week 6, week 12, and at a 6-month follow-up. Inclusion criteria include diagnosis of MDD, competence to consent to participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include active psychosis, acute mania, severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. The results from this study can provide valuable information used to develop more accessible and scalable mental health interventions with increased care capacity for MDD, without sacrificing the quality of care.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression; e-CBT; Online Psychotherapy; Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (3)

• Change in symptoms - Patient Health Questionnaire - 9 Item

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

  Week 1, Week 6, Week 12, 6-Month Follow-Up

• Change in symptoms (Quick Inventory of Depressive Symptomatology)

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

  Week 1, Week 6, Week 12, 6-Month Follow-Up

• 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, Week 6, Week 12, 6-Month Follow-Up

Secondary Outcomes (2)

• Qualitative Analysis - Healthcare Provider Experience

  Week 12 (Post-Treatment)

• Qualitative Analysis - Participant Experience

  Week 12 (Post-Treatment)

Study Arms (2)

e-CBT

EXPERIMENTAL

Weekly e-CBT sessions will occur through Online Psychotherapy Tool (OPTT) and consist of slides and interactive therapist videos. Content and format mirrors live CBT. Slides will highlight a different topic each week and include general information, overview of skills, and homework. Homework will be submitted through OPTT and reviewed by administrators with personalized feedback within three days. Weekly homework submission will be mandatory before beginning the next session. DASS 21 and Q-LES-Q-SF questionnaires will be completed at the beginning and end of treatment. After each cycle of e-CBT, patients and healthcare providers involved in e-CBT will be recruited for focus groups once they have completed their 12-week program. Qualitative data will be gathered through 10 focus groups. The focus group prompts will pertain to experience and expectations of service. Patients will be contacted six months after treatment to complete DASS 21 and Q-LES-Q-SF questionnaires.

Behavioral: e-CBT

Live CBT

ACTIVE COMPARATOR

The content and format of live CBT will be mirrored by the e-CBT group over the course of 12 weeks. The sessions will highlight a different topic each week and include general information, an overview of skills, and homework on that topic. Live CBT homework will be reviewed by the CBT group organizer and provided at the beginning of the next CBT session. Weekly homework submission for feedback will be mandatory before being eligible for the next session. DASS 21 and Q-LES-Q-SF questionnaires will be completed at the beginning and end of treatment for both live and e-CBT. All live and e-CBT patients will be contacted six months after the completion of their CBT to complete final DASS 21 and Q-LES-Q-SF questionnaires. This will allow for the examination of the longevity of e-CBT compared to live CBT.

Behavioral: Live CBT

Interventions

Live CBT BEHAVIORAL

Weekly in-person Cognitive Behavioural Therapy

Live CBT

e-CBT BEHAVIORAL

Weekly online Cognitive Behavioural Therapy

e-CBT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 16 years old at the start of the study
• Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) by a clinician
• Competence to consent to participate
• Ability to speak and read English
• Consistent and reliable access to the internet

You may not qualify if:

• High current suicide risk (score of over 17 points on section C, Suicidality, of MINI)

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (2)

• Alavi N, Moghimi E, Stephenson C, Gutierrez G, Jagayat J, Kumar A, Shao Y, Miller S, Yee CS, Stefatos A, Gholamzadehmir M, Abbaspour Z, Shirazi A, Gizzarelli T, Khan F, Patel C, Patel A, Yang M, Omrani M. Comparison of online and in-person cognitive behavioral therapy in individuals diagnosed with major depressive disorder: a non-randomized controlled trial. Front Psychiatry. 2023 Apr 28;14:1113956. doi: 10.3389/fpsyt.2023.1113956. eCollection 2023.

  PMID: 37187863 DERIVED

• Alavi N, Stephenson C, Yang M, Kumar A, Shao Y, Miller S, Yee CS, Stefatos A, Gholamzadehmir M, Abbaspour Z, Jagayat J, Shirazi A, Omrani M, Patel A, Patel C, Groll D. Feasibility and Efficacy of Delivering Cognitive Behavioral Therapy Through an Online Psychotherapy Tool for Depression: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jun 16;10(6):e27489. doi: 10.2196/27489.

  PMID: 33990076 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Nazanin Alavi, MD FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Participants will be offered to take part in either live or online Cognitive Behavioural Therapy for a 12 week period.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: June 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)