Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04630197 |
| Other study ID # |
48144 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
July 28, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Queen's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will implement an e-CBT program for OCD and observe its effects on brain
activation levels using functional magnetic resonance imaging (fMRI). It is hypothesized that
brain activation levels in the basal ganglia and frontal cortex will decrease following
treatment. Individuals with OCD will be offered a 16-week e-CBT program with ERP mirroring
in-person CBT content that will be administered through a secure online platform. Efficacy of
treatment will be evaluated using clinically validated symptomology questionnaires at
baseline, week 8, week 16, and at a 6-month follow-up. Using fMRI at baseline and
post-treatment, brain activation levels will be assessed at resting state, and while exposed
to anxiety-inducing images (i.e., dirty dishes if cleanliness is an obsession). The effects
of treatment on brain activation levels and the correlation between symptom changes and
activation levels will be analyzed.
Description:
Study Design:
A non-randomized pilot study design will be employed. Functional magnetic resonance imaging
(fMRI) will be conducted at baseline and post-treatment to evaluate activation level changes
in the basal ganglia and frontal cortex. Clinically validated symptomology questionnaires
will be used to evaluate treatment efficacy. Additionally, qualitative interviews will be
conducted to gather personal demographic information as well as information regarding
participant experience while using the online psychotherapy clinic. This study has been
registered on the ClinicalTrials.Gov Protocol Registration and Results System (NCT04630197).
Additionally, ethics approval has been obtained from the Queen's University Health Sciences
and Affiliated Teaching Hospitals Research Ethics Board (HSREB).
Participants:
Participants (n = 10) will be recruited from family medicine and psychiatric clinics at
Queen's University and Kingston Health Sciences Centre sites (Hotel Dieu Hospital and
Kingston General Hospital) in Kingston, Ontario, Canada. Additionally, local and social media
advertisements will be utilized. Participants will be enrolled in the study based on
referrals from outpatient clinics, family doctors, as well as self-referrals. Those invited
and interested in participating will have the study protocol explained along with an
evaluation by a psychiatrist on the research team through a secured video appointment.
Participants will be evaluated for a diagnosis of OCD based on the Diagnostic and Statistical
Manual of Mental Disorders, 5th Edition (DSM-5) [48]. Once a diagnosis of OCD is confirmed
and the participant is given written and verbal instructions on how to participate in the
online therapy, informed consent will be obtained. Inclusion criteria include the following:
between the ages of 18 and 65 years at the start of the study, a diagnosis of OCD according
to DSM-5, competence to consent to participate, ability to speak and read English, and
consistent and reliable access to the internet. Exclusion criteria include having any metal
implants or additional factors deemed not safe to undergo an MRI scan, active psychosis,
acute mania, severe alcohol or substance use disorder, and/or active suicidal or homicidal
ideation. Additionally, if a participant is receiving another form of psychotherapy, they
will be excluded from the study.
e-CBT Protocol: Weekly sessions of e-CBT will be conducted through the Online Psychotherapy
Tool (OPTT), a secure, online, cloud-based mental health care delivery platform. These online
sessions will consist of approximately 30 slides and interactive therapist videos, with 16
modules in total (1 module per week). The content and format of these online sessions will
mirror in-person CBT for OCD. The connection between thoughts, behaviours, emotions, physical
reactions, and the environment will be a focus. Moreover, mindfulness, body scanning,
self-care, goal setting, thinking errors, the 5-part model, and thought records will be
employed as techniques for participants. ERP will be incorporated into the e-CBT program as
this is the first-line route of treatment. Slides will highlight different topics each week
and include general information, an overview of skills, and homework on that topic. The
homework included in each session will be submitted through OPTT and reviewed by therapists
with personalized feedback provided within 3 days of submission. Weekly homework submission
for feedback will be mandatory before being eligible for the next session. After each
completion of the e-CBT program, participants will be interviewed to investigate their
experience using OPTT and their perception of how the treatment went. Participants can access
their therapy sessions from any device with internet access (desktop computer, laptop,
cellphone, tablet) and can be run on a variety of internet browsers.
fMRI Protocol: All imaging procedures will occur at the Queen's University MRI Facility in
Kingston, Ontario, Canada using a Siemens 3.0 Tesla whole-body MRI scanner with a standard
coil. Scans will occur at baseline (pre-treatment), after week 16 (post-treatment, and at a
6-month follow-up. During scanning, participants will lay on the scanning table on their
back, with their head resting on a foam pad to reduce movement. Appointments will be 1 hour.
Anatomical reference images will be captured initially. Following this, fMRI scans will occur
while participants are shown neutral images and anxiety-inducing images (i.e., dirty dishes
if cleanliness is an anxiety-inducing concept for a specific participant). The frontal cortex
and basal ganglia will be the focuses of the imaging procedures as we are interested in the
activation level changes during neural anxiety processing. These images will be standardized
pictures from the International Affective Picture System (IAPS) that will be selected
specifically for each patient by members of our research team.
Participants will be shown a total of 40 images (20 neutral, 20 anxiety-inducing; R = 0.5)
during the fMRI scans. There will be 4 fMRI runs that occur in the following sequence:
- 5 neutral images (30s per image, 5s break between), 1-minute break, 5 anxiety-inducing
images (30s per image, 5s break between), 1-minute break.
- 5 new anxiety-inducing images (30s per image, 5s break between), 1-minute break, 5 new
neutral images (30s per image, 5s break between), 1-minute break.
- 5 new anxiety-inducing images (30s per image, 5s break between), 1-minute break, 5 new
neutral images (30s per image, 5s break between), 1-minute break.
- 5 neutral images (30s per image, 5s break between), 1-minute break, 5 anxiety-inducing
images (30s per image, 5s break between).
The images will be shown in sets (groups of 5) as opposed to intermingled as we hope this
will produce a more sustained emotional state and allow for more distinct readings. The
reasoning of the sets being repeated in the middle (back-to-back of the anxiety-inducing
images in the example above) is for participants to not become as accustomed to the ordering.
Moreover, we will change this ordering for every participant (i.e, The next participant would
receive back-to-back sets of the neutral imaging in runs 2 and 3). This is done to
counterbalance the imaging sets. Participants will be prompted to imagine themselves in the
situations described in the images. The images will appear on a screen and then be reflected
into the scanner for participants to view. 0.5% blood oxygen level-dependent (BOLD) signal
difference between conditions (p < 10-6) will be considered a detectable change (eff =
0.005).
Anatomical reference images will be captured with the phase encoding direction collected
sagitaly from anterior to posterior. These images will be captured with T1-weighted
high-resolution magnetization prepared rapid acquisition gradient echo (MPRAGE) images with 1
x 1 x 1 mm3 isotropic voxels. For the stimuli-exposed image acquisitions, T2*-weighted
gradient-echo echo-planar imaging (GE-EPI) with 1.5 x 1.5 x 2 mm3 voxels will be used. A flip
angle of 90 degrees and a bandwidth of 1500 Hz will be used. The field of view will be 192 x
192 mm with a 64 x 64 mm matrix resolution. With this phase encoding, the spatial resolution
will be 3 mm, with an echo time (TE) of 25 ms, a repetition time (TR) of 2.5 s, and a
multi-slice imaging factor of 2 being employed. With these parameters, 170 volumes will be
captured. To un-distort images, the GE-EPI fMRI data will be mapped to a non-distorted set of
GE images from the same participant. Next, the non-distorted GE images will be mapped to the
T1-weighted MPRAGE image. Finally, the T1-weighted MPRAGE will be mapped to the Montreal
Neurological Institute (MNI) standardized brain template. In doing this, the GE-EPI fMRI data
will be mapped to the MNI template with maximum accuracy.
