Using Online Delivered Therapy and Brain Imaging to Better Understand OCD

NCT04630197 | Completed

• 1 other identifier: 48144
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Psychotherapy; MRI; fMRI; Cognitive Behavioural Therapy; Mental Health Care; Virtual; Online; Internet; Electronic

Outcome Measures

Primary Outcomes (5)

• Changes in Brain Structure and Activation: Functional Magnetic Resonance Imaging (fMRI)

  fMRI will be administered to observe any changes in structure.

  Week 1, Week 16

• Changes in symptoms: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  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

  Week 1, Week 8, Week 16, 6 Months

• Changes in symptoms: Obsessive-Compulsive Inventory - Revised (OCI-R)

  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.

  Week 1, Week 8, Week 16, 6 months

• Changes in Quality of Life: Quality of Life and Enjoyment Questionnaire (Q-LES-Q)

  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

  Week 1, Week 8, Week 16, 6 months

• Changes in level of functioning: Sheehan Disability Scale (SDS0

  SDS will be administered to analyze changes in levels of functioning. Scale of 0-10, 10 being the worst.

  Week 1, Week 8, Week 16, 6 Months

Study Arms (1)

e-CBT

EXPERIMENTAL

16 weekly sessions will be conducted through OPTT and consist of approximately 30 slides and interactive therapist videos. The content and format 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, thought records, and ERP will be incorporated. Slides will highlight different topics each week and include general information, an overview of skills, and homework on that topic. The homework 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.

Behavioral: e-CBT

Interventions

e-CBT BEHAVIORAL

The description is provided in the treatment arm description.

e-CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Metal implants
• Active psychosis
• Acute mania
• Severe alcohol or substance use disorder
• Active suicidal or homicidal ideation
• Receiving any additional form of psychotherapy

Sponsors & Collaborators

• Callum Stephenson: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• Stephenson C, Malakouti N, Nashed JY, Salomons T, Cook DJ, Milev R, Alavi N. Using Electronically Delivered Therapy and Brain Imaging to Understand Obsessive-Compulsive Disorder Pathophysiology: Protocol for a Pilot Study. JMIR Res Protoc. 2021 Sep 14;10(9):e30726. doi: 10.2196/30726.

  PMID: 34348889 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Callum Stephenson, BScH

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator, MSc Candidate

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 28, 2022
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)