Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04747873 |
| Other study ID # |
PSYC-247-21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2021 |
| Est. completion date |
July 19, 2023 |
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
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.
Description:
Participants Participants (n = 110; 55 e-CBT participants, 55 e-CBT + stepped care
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.
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.
e-CBT 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 standard CBT content, including different weekly topics, general information, skill
overviews, and homework. 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, a 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.
Stepped Care Procedure For the stepped care e-CBT group, the decision of whether to add in
the additional care will be made starting at the end of week 3. This decision will be made by
the principal investigator using the questionnaire and wearable tracker data (Fitbit). The
wearable will record heart rate, sleep patterns, and physical activity information. Five
possible interventions (see below) may be implemented on a step-by-step basis. If the
participant does not show signs of improvement, they will advance to the next step with a
total of five steps. Once the participant advances to the next step, they can revert to a
previous step if they show signs of improvement or once again advance to the next step if
they do not show signs of improvement.
Step 1 (Message from Therapist): The participant will receive a message from their assigned
care provider on OPTT who check in with them about some of the strategies and techniques they
will have discussed and remind them of their weekly homework due date.
Step 2 (Phone Call): The participant will receive a phone call from their therapist who will
check in on them, remind them of some therapy strategies and techniques, and verbally and
remind them of their weekly homework due date.
Step 3 (Enhanced Telephone Call): The participant will receive a telephone call from their
assigned care provider who will check in on them, remind them of some therapy strategies and
techniques and their weekly session due date, and provide a CBT summary of previously
reviewed CBT concepts.
Step 4 (Video Call): The participant will receive a video call (via Microsoft Teams) from
their therapist who will check in on them, remind them of their weekly session due to date,
and provide CBT content support to the participant.
Step 5 (Video Call Sessions): The final stage involves the participant receiving their CBT
sessions in a live video call format (via Microsoft Teams) with the research psychiatrist
involved in their care.
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.
