Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04478058 |
| Other study ID # |
PSIY-563-17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
September 30, 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
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.
Description:
Study Design For this study, a non-randomized, controlled trial study design will be
employed. Qualitative focus groups will be conducted to gather personal demographic
information as well as information regarding the feasibility of implementing an online
psychotherapy clinic. Additionally, quantitative analyses of e-CBT treatment efficacy will be
conducted using standardized and clinically validated symptomology questionnaires. All study
procedures have been approved by the Queen's University Health Sciences and Affiliated
Teaching Hospitals Research Ethics Board.
Participants Patients (n = 110; 55 e-CBT participants, 55 in-person CBT participants) aged
18-65 years will be recruited at Queen's University from outpatient psychiatry clinic at both
Kingston Health Sciences Centre sites (Hotel Dieu Hospital and Kingston General Hospital) as
well as Providence Care hospital, family doctors, physicians, clinicians, and self-referrals
in Kingston, Ontario, Canada. Once informed consent is provided, participants will be
evaluated by a psychiatrist on the research team through secure video appointment to make or
confirm a diagnosis of Major Depressive Disorder (MDD) using the Diagnostic and Statistical
Manual of Mental Disorders, 5th Edition (DSM-5).
The inclusion criteria for the study include the following: at least 18 years of age at the
start of the study, diagnosed with major depressive disorder according to DSM-5 by an
attending psychiatrist on the research team, 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. If a participant is receiving another form of
psychotherapy, they will also be excluded from the study, to avoid any confounding effect on
the efficacy of this e-CBT program. If eligible for the study, participants will choose
between the e-CBT program (n = 55) or the in-person CBT offered individually through this
program at Hotel Dieu Hospital (n = 55).
During the informed consent process, it is explained to all participants that this program is
not a crisis resource and that they will not have access to their therapist at all times. In
the case of an emergency, participants are directed to the proper resources (e.g., emergency
department, crisis lines, etc.) and this event will be reported to the principal investigator
of the study.
Procedures The e-CBT care plan consists of 12 weekly sessions of approximately 30 slides and
interactive content, delivered through OPTT. The e-CBT module content mirrors in-person group
CBT content, including different weekly topics, general information, skill overviews, and
homework. The efficacy of the therapeutic content has previously been tested through email
administration and shown to significantly reduce depressive symptoms Participants are
instructed to go through the content and complete homework at the end of the session which
helps them practice skills they learned through that 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. At the same time, by using a structured format
in responding to patients, more standardized quality of care can be assured. The general
structure of the feedback template is as follows: -validating the participant's time and
effort, -reviewing the event they have used in their homework, -summarizing the previous
module's content, and -discussing the participant's homework submission and how they could
improve it. In addition to these points, the feedback will have an emphasis on specific
content from the participant's submission, reassuring them that their therapist is reading
and understanding their challenges. All feedback submissions are finished with a personalized
signature from the therapist, helping to develop a rapport between the therapist and the
participant. 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. All technical issues are handled directly through OPTT's technical support team.
Participants in the in-person CBT group will attend weekly sessions at Hotel Dieu Hospital
(12 weeks) where they will receive standardized individual (one-on-one) CBT for MDD from a
trained therapist. All content covered and skills taught will mirror the e-CBT program.
Similar to the e-CBT group, participants will be assigned weekly homework assignments that
they will complete during the week and hand-in at the start of their next session. At this
time, participants will receive personalized feedback for their previous week's homework from
their therapist.
At the end of the study, a few participants and healthcare providers (i.e., 8 participants, 2
providers) are recruited for focus groups. The focus group prompts will pertain to experience
and expectations of service during the study and how they think the service could be
improved.
Online Module Content Both e-CBT modules and in-person CBT sessions are designed to instill
constructive and balanced coping strategies in participants. During the program, we focus on
essential thinking and behavioural skills to help the patients become more engaged in
day-to-day activities. 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.
Training All therapists are research assistants hired by the principal investigator. They all
undergo training in psychotherapy and additional training from a psychiatrist on the research
team before any interaction with participants. During this training, therapists complete
feedback on practice homework, which is reviewed by a psychiatrist on the research team to
ensure adequate quality of work. All therapists are supervised by the lead psychiatrist, who
is an expert in the area of electronically delivered psychotherapy. Feedback is always
reviewed by the lead psychiatrist, before submission to the participants.
