Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04754438 |
| Other study ID # |
6032033 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
September 2024 |
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 study will compare the efficacy of an electronically-delivered cognitive behavioural
therapy (e-CBT) program versus a mental health coaching program to treat generalized anxiety
disorder (GAD). This randomized trial intervention will provide the e-CBT and mental health
coaching for GAD through a secure, online platform. Participants will be between the ages of
18 and 65 years with a confirmed diagnosis of GAD according to the Diagnostic and Statistical
Manual of Mental Disorders - 5th Edition (DSM-5). Participants will either be offered an
e-CBT program tailored to GAD or an online mental health coaching program over 12 weeks to
address their anxiety symptoms. e-CBT participants will complete pre-designed modules and
homework assignments while receiving personalized feedback and asynchronous interaction with
a therapist through the platform. Participants in the coaching group will be contacted weekly
through the online platform's chat feature. Therapists will ask the participants a series of
pre-designed questions that revolve around a different theme each week to prompt
conversation. Using clinically validated symptomology questionnaires, the efficacy of the
e-CBT program will be compared to the coaching group. These questionnaires will be completed
at baseline, week 6, week 12, and at a 6-month follow-up. Questionnaires include the
State-Trait Anxiety Inventory (STAI), the Quality of Life Enjoyment and Satisfaction
Questionnaire - Short Form (Q-LES-Q-SF), the Generalized Anxiety Disorder - 7 Item (GAD-7),
and the Depression Anxiety Stress Scale - 42 Item (DASS-42).
Description:
This randomized trial intervention will provide e-CBT for GAD through the Online
Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform.
Participants (age: 18-65 years) will be randomly assigned to either an e-CBT program tailored
to GAD or a mental health coaching program over 12 weeks to address their anxiety symptoms.
In the e-CBT group, 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 GAD. 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. In the mental health
coaching group, participants will have weekly interaction with a therapist through the chat
function in OPTT where the coach will check in on the participant and touch on a specific
subject each week.
Participants (n = 110; 50 e-CBT participants, 50 coaching) aged 18-65 years will be recruited
at Queen's University from outpatient psychiatry clinics at both Kingston Health Sciences
Centre sites (Hotel Dieu Hospital and Kingston General Hospital). Additional recruitment will
occur from 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 appointments to
make or confirm a diagnosis of a generalized anxiety disorder (GAD) using the Diagnostic and
Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
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.
Both e-CBT modules and in-person CBT sessions are designed to instill constructive and
balanced coping strategies in participants. During the program, the focus will be 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. The goal is to
change how patients evaluate 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.
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. 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.
Participants in the coaching treatment program will have weekly interactions with a therapist
through the chat feature in OPTT. The therapist will reach out weekly using the following
structured question prompts to initiate interaction with their patient:
Week 1 - Mood: Tell me about yourself. How have you been feeling lately? How has the pandemic
affected your mood? What differences have you noticed in your mood compared to the past? Week
2 - Sleep: How have you been? Tell me about your week. I want to ask about your sleep. How
many hours do you get? Do you feel rested? Do you think you need to make any changes to your
sleep hygiene? Week 3 - Activity: How was your week? How has your anxiety level been? What do
you usually do to stay active during the days? Are there any indoor activities you can do at
your place? Have you been using any online exercise programs? Week 4 - Hobbies: What did you
do in the past week? Do you have any hobbies? How long have you been doing them? Have you
found any new activities that you enjoy recently? Week 5 - Friendship: How was your week? How
has the pandemic affected your relationship with your friends? Have you stayed in touch with
your close friends during the pandemic? How often do you interact with your friends? Week 6 -
New Events: How have you been? Have there been any new events in the past weeks? Are you
planning to do anything new this week? Are you planning to do anything new this week? Are you
expecting to hear any news from your family/friends? Week 7 - Job/Study: How have you been?
Tell me about your week. How are you managing your day-to-day responsibilities (e.g., job,
school, personal, etc.)? Week 8 - Diet/Food: How was your week? Let's talk about your eating
habits. How does your anxiety affect your appetite? Are you satisfied with your diet? How
often do you cook? Do you prefer home-made food or take-out? Week 9 -
Books/Movies/Television: How was your week? Has your anxiety affected your concentration? Do
you like reading books? What is the last book you read? Are there any books you would
recommend to your friends? What shows do you enjoy watching? What are some shows you would
recommend to your friends? Week 10 - Phone/Apps/Games: Tell me about your week. How many
hours a day do you usually spend on your phone? What is your favourite app? Do you play any
games? What kinds of games do you like to play (e.g., board games, cards, video games, etc.)?
Week 11 - Habits: How have you been? How was your week? What do you think are some of your
healthy habits? What are some habits you would like to change? Week 12 - Accomplishments: How
was your week? How did you find this program? Were the weekly check-ins helpful? Overall, was
this program helpful for you? Why or why not Are you interested in 12 weeks of online
cognitive behavioural therapy? Why or why not?
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.
Participants will only be identifiable by an anonymous identification number and any hard
copies of consent forms will be stored securely in a locked filing cabinet and destroyed 5
years after study completion. Participant data will only be accessible by the care providers
directly assigned to the participant and only anonymized data will be provided to the
analysis team members. Participants will have the option to withdraw from the study at any
point and request for their data to be removed from the analysis.
OPTT is Health Insurance Portability and Accountability Act (HIPAA), Personal Information
Protection and Electronic Documents Act (PIPEDA), and Service Organization Control - 2
(SOC-2) compliant. Additionally, all servers and databases are hosted in Amazon Web Service
(AWS) Canada cloud infrastructure which is managed by Medstack to assure all provincial and
federal privacy and security regulations are met. OPTT does not collect any identifiable
personal information or Internet Protocol (IP) addresses for privacy purposes. OPTT only
collects anonymized metadata to improve its service quality and provide advanced analytics to
the clinician team. OPTT encrypts all data, and no employee has direct access to participant
data. All encrypted backups will be kept in the S3 storage that is dedicated to Queen's
University.
