Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04476667 |
| Other study ID # |
PSIY-683-20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
April 2024 |
| Source |
Queen's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The recent COVID-19 pandemic has affected many aspects of individuals social life and its
negative consequences on Canadian public health go far beyond the direct overload of the
hospital care system. Self-isolation and financial uncertainty can significantly deteriorate
individuals' mental health, which is only going to aggravate with prolonged physical
distancing strategies. Adding to this is the personal and public trauma of lost lives and
soon there will be an unprecedented epidemic of mental health problems with crushing effects
on the public health sector and economy. To meet this huge new demand for an already strained
health system, there is a need for innovative new approaches that significantly expand the
capacity of care delivery. While it may not be possible in the short term to increase the
number of mental healthcare providers or the number of hours they work, improving their time
spent efficiently might be the solution. Virtual care and online delivery of psychotherapy,
shown to be clinically effective, efficient and cost-effective, might be the perfect solution
to address the high demand faced now. The investigators aim to establish the first academic
online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal
is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues
in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The
investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital
mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care
delivery could increase care capacity by four-folds. The findings from this project have the
potential to influence clinical practice and policy and increase accessibility to care during
COVID-19 pandemic, without sacrificing the quality of care.
Description:
Participants: Participants (n=80) aged 18-65 years will be recruited from referrals within
the outpatient clinics of HDH and PCH. Participants who consent to take part in the study
will be evaluated by one of the psychiatrists on the team through a video appointment.
Diagnosis of MDD and/or GAD will be confirmed using the DSM-5 and approved through the
M.I.N.I. The inclusion criteria for the study will include the capacity to consent; a
diagnosis of MDD and/or GAD, the ability to speak and read English, and having 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. If a
participant is receiving another form of psychotherapy, they will also be excluded from the
study. If eligible for the study, participants will be randomly assigned to either the
electronic psychotherapy (e-psychotherapy) or control (i.e. Treatment as usual (TAU)) group,
stratified by sex, age group, and gender.
Participants selected for the e-psychotherapy group will receive a 9-week program that
includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU.
The content of the e-psychotherapy program will be customized to reflect the challenges that
individuals face through the COVID-19 pandemic and will be developed into interactive and
engaging therapy modules. All online sessions and interactions will occur through Online
Psychotherapy Tool (OPTT), a secure online platform.
Through OPTT, all participants will be assigned to a team of psychiatrists and social workers
(SWs). The SW working with each patient will assign a pre-designed therapy module to that
patient on a specific day of the week through OPTT. Participants will then be able to access
the therapy content at any time throughout the week. Each weekly module will highlight a
different topic and include general information, an overview of skills, and homework that is
to be completed by a specific day that week. Completing each weekly module requires an
average time commitment of 40-minutes, which can be completed at once or in blocks of time.
This homework will be directly submitted through OPTT to the clinician who will then provide
personalized feedback to the patient. To ensure a consistent high-quality outcome, SWs will
use pre-designed session-specific feedback templates to respond to each weekly patient
submission. Each patient's care team will be able to securely communicate through OPTT to
make decisions regarding each patient's care path. The control group will receive treatment
as usual during the first 9 weeks; if they still present significant symptoms (less than 50%
response to treatment from baseline), they will be offered the e-psychotherapy program.
Module Content: The first 3 sessions will be designed to address the symptoms caused by fear
of illness or concerns about personal safety in the context of a pandemic. Electronic-CBT
(e-CBT) modules will focus on problem-solving techniques, with mindfulness practices
included, to help build healthy coping skills to address the uncertainties surrounding the
COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive
and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep
hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the
connection between thoughts, behaviours, emotions, physical reaction and one's environment.
Training: Through training, all SWs will learn the standard care pathway, the aim, and the
content of each therapeutic session. Moreover, they will be provided sample homework from a
patient and asked to provide feedback. Feedback templates will vary from session to session
and SWs will personalize each template for each patients' homework. Training will occur
through webinars and exercises with feedback.
Outcome Evaluation: Primary outcomes measured will be stress level changes based on the
DASS-21, resilience based on RS-14, and quality of life-based on Q-LES-Q. Additional
measurements will be made based on participant diagnosis (PHQ9, MADRS, GAD7). All
questionnaires will be collected directly through OPTT at baseline, session 6, after the
final session, and at a 6-month follow up. Healthcare providers will be asked about the
feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with
respect to time commitment, feelings of 'connectedness' to the participant, and any perceived
benefits/drawbacks to e-psychotherapy. From focus groups, factors related to personal,
social, and cultural factors (gender, sexuality, background, supportive resources,
structural/social barriers, etc.) will be extracted using an Interpretive Phenomenological
Analysis (IPA) approach.
Ethics and Data Privacy: All procedures have been submitted for approval of ethical
compliance to the Queen's University Health Sciences and Affiliated Teaching Hospitals
Research Ethics Board. Only the care providers involved in the care of the participant will
have access to their chart. Patients will only be identifiable by an ID number on the OPTT
platform and their real identity and consent forms will be stored locally in a locked file
cabinet and destroyed 5 years after the study completion date. Only anonymized data will be
provided to the analysis team members.
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS
Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal
privacy and security regulations are met. OPTT will not collect any identifiable personal
information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata
to improve its service quality and provide advanced analytics to the clinician team. All data
is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups
are kept in the S3 storage that is dedicated to Queen's University.
Data Analysis: Repeated MANOVA will be used to evaluate treatment efficacy in changes in
scores on the DASS-21, RS-14 & Q-LES-Q between the participant groups (TAU, anxiety, and
depression), and changes within each specific diagnosis at four different time points.
Thematic analysis will be applied to analyze survey questions in order to better capture
experiences, acceptability and patient-centeredness of e-psychotherapy. Descriptive analysis
of time spent by each care team member for individual participants to evaluate the cost
efficiency of care delivery will occur.
