Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630197
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-11-05
Brief Title:
Using Online Delivered Therapy and Brain Imaging to Better Understand OCD
Sponsor:
Callum Stephenson
Organization:
Queens University
Study Overview
Official Title:
Using Electronically Delivered Cognitive Behavioural Therapy and Functional Magnetic Resonance Imaging to Understand the Pathophysiology of Obsessive-compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 ClinicalTrialsGov Protocol Registration and Results System NCT04630197 Additionally ethics approval has been obtained from the Queens 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 Queens 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 andor 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 Queens University MRI Facility in Kingston Ontario Canada using a Siemens 30 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 ie 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 05 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 ie 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 05 blood oxygen level-dependent BOLD signal difference between conditions p 10-6 will be considered a detectable change eff 0005
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 15 x 15 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 25 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
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 ClinicalTrialsGov Protocol Registration and Results System NCT04630197 Additionally ethics approval has been obtained from the Queens 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 Queens 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 andor 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 Queens University MRI Facility in Kingston Ontario Canada using a Siemens 30 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 ie 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 05 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 ie 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 05 blood oxygen level-dependent BOLD signal difference between conditions p 10-6 will be considered a detectable change eff 0005
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 15 x 15 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None