Using Electronically Delivered Cognitive Behavioural Therapy and Functional Magnetic Resonance Imaging to Understand the Pathophysiology of Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in Quality of Life: Quality of Life and Enjoyment Questionnaire (Q-LES-Q)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of OCD made by a psychiatrist on the research team
- •Competence to consent to participate
- •Ability to speak and read English
- •Consistent and reliable access to the internet
排除标准
- •Metal implants
- •Active psychosis
- •Acute mania
- •Severe alcohol or substance use disorder
- •Active suicidal or homicidal ideation
- •Receiving any additional form of psychotherapy
结局指标
主要结局
Changes in Quality of Life: Quality of Life and Enjoyment Questionnaire (Q-LES-Q)
时间窗: Week 1, Week 8, Week 16, 6 months
Q-LES-Q will be administered to analyze changes in quality of life from treatment. Scale of 0-5 for each question with 0 being not at all and 5 being frequently
Changes in level of functioning: Sheehan Disability Scale (SDS0
时间窗: Week 1, Week 8, Week 16, 6 Months
SDS will be administered to analyze changes in levels of functioning. Scale of 0-10, 10 being the worst.
Changes in symptoms: Obsessive-Compulsive Inventory - Revised (OCI-R)
时间窗: Week 1, Week 8, Week 16, 6 months
OCI-R will be administered to analyze changes in symptoms from treatment. Scale of 0-4 with 0 being not at all and 4 being extreme severity.
Changes in Brain Structure and Activation: Functional Magnetic Resonance Imaging (fMRI)
时间窗: Week 1, Week 16
fMRI will be administered to observe any changes in structure.
Changes in symptoms: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
时间窗: Week 1, Week 8, Week 16, 6 Months
Y-BOCS will be administered to analyze changes in symptoms from treatment. Scale of 0-4 for each question with 0 being no symptom severity and 4 being high symptom severity
次要结局
未报告次要终点
研究者
Callum Stephenson
Principle Investigator, MSc Candidate
Queen's University
