Using Online Delivered Therapy and Brain Imaging to Better Understand OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): e-CBT
Intervention type(s): Behavioral
Intervention description(s): The description is provided in the treatment arm description.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Psychotherapy; MRI; fMRI; Cognitive Behavioural Therapy; Mental Health Care; Virtual; Online; Internet; Electronic