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Feasibility and Effectiveness of Delivering CBT Through OPTT for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04478058
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : May 31, 2022
Sponsor:
Collaborator:
Online PsychoTherapy Clinic
Information provided by (Responsible Party):
Dr. Nazanin Alavi, Queen's University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Live CBT Behavioral: e-CBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be offered to take part in either live or online Cognitive Behavioural Therapy for a 12 week period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Effectiveness of Delivering Cognitive Behaviour Therapy Through Online Psychotherapy Tool (OPTT) for Depression
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: e-CBT
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
Weekly online Cognitive Behavioural Therapy

Active Comparator: Live CBT
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
Weekly in-person Cognitive Behavioural Therapy




Primary Outcome Measures :
  1. Change in symptoms - Patient Health Questionnaire - 9 Item [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]
    Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

  2. Change in symptoms (Quick Inventory of Depressive Symptomatology) [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]
    Clinical standardized symptom questionnaire. Scale of 0-3, 3 being the worst.

  3. Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire) [ Time Frame: Week 1, Week 6, Week 12, 6-Month Follow-Up ]
    Clinical standardized symptom questionnaire. Scale of 1-5, 1 being the worst.


Secondary Outcome Measures :
  1. Qualitative Analysis - Healthcare Provider Experience [ Time Frame: Week 12 (Post-Treatment) ]
    Focus groups for healthcare providers who will be asked about feasibility of providing the e-psychotherapy program, how it compares to in-person psychotherapy.

  2. Qualitative Analysis - Participant Experience [ Time Frame: Week 12 (Post-Treatment) ]
    Interviews with participants regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478058


Locations
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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 5G3
Sponsors and Collaborators
Queen's University
Online PsychoTherapy Clinic
Investigators
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Principal Investigator: Nazanin Alavi, MD FRCPC Queen's University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Nazanin Alavi, Principal Investigator, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT04478058    
Other Study ID Numbers: PSIY-563-17
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information from this study is confidential and patients' anonymity will be protected. e-CBT participants will have a password-protected encrypted file through the OPTT. Questionnaires and homework submitted via OPTT can only be accessed by psychiatrists involved in the study and clinicians involved in their care. Data from this research will be saved without mention of any patient names with all patients being identified with a unique identification number in all data from this study. A master file of participant ID numbers and participant names will be maintained in a password-protected encrypted file and destroyed once the study has been completed. Hard copies of patient study files will be stored in locked cabinets and offices and will be available only to clinicians providing treatment and Research Coordinator. Participants will not be identified in any publication or reports.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Nazanin Alavi, Queen's University:
Major Depressive Disorder
Depression
e-CBT
Online Psychotherapy
Cognitive Behavioural Therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders