Cognitive Training in Obsessive Compulsive Disorder (CTOCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Terminated
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
n-Back (Cognitive Training)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- A primary diagnosis of OCD, with a score > 16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (Goodman et al, 1989b, 1006-1011).
- Participants must be aged older than 18 and younger than 65 years.
- Right handed.
- If taking SSRI's the participant needs to be on a stable dose for at least 2 months.
Exclusion Criteria:
- Significant physical or neurological illnesses. An exception will be made for patients taking SSRI's (and not using any other drugs).
- Any significant current DSM disorder (in addition to OCD).
- Past history of significant substance or alcohol abuse.
- Pregnancy.
- Any metal pins/ prostheses or cardiac pacemakers.
- Sufferers of claustrophobia.
- Head injury
Sites / Locations
- Stellenbosch University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Training
Arm Description
Cognitive Training - n Back.
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Cambridge neuropsychological test automated battery (CANTAB)
Secondary Outcome Measures
Full Information
NCT ID
NCT02818088
First Posted
June 27, 2016
Last Updated
May 3, 2021
Sponsor
University of Stellenbosch
Collaborators
University of Cape Town
1. Study Identification
Unique Protocol Identification Number
NCT02818088
Brief Title
Cognitive Training in Obsessive Compulsive Disorder
Acronym
CTOCD
Official Title
Cognitive Training in Patients With Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
The app platform was cancelled and key personnel withdrew from the project
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch
Collaborators
University of Cape Town
4. Oversight
5. Study Description
Brief Summary
This unique study will allow us to observe the neural correlates associated with working memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing working memory in participants suffering with OCD will reduce the severity of their symptomology. This will allow a greater understanding into the functioning of these participants which in turn presents with treatment possibilities.
Detailed Description
It is currently unclear whether cognitive training using a working memory task, is effective in reducing obsessive-compulsive symptoms and neuropsychological deficits in patients with OCD. Two groups (OCD and control) will be recruited. Both groups will undergo an intervention consisting of 8 weeks of cognitive training. Working memory, neuropsychological functioning and OCD symptomatology will be assessed pre and post-treatment, in both groups. Furthermore neuroimaging using functional magnetic resonance imaging (fMRI) will be conducted at baseline as well as at the end of the 8 week period in both groups. The scan will serve to show any structural or functional changes in the frontostriatal area involved with working memory. To our knowledge, this is one of the first studies to date to examine whether cognitive training improves symptoms in OCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Cognitive Training - n Back.
Intervention Type
Behavioral
Intervention Name(s)
n-Back (Cognitive Training)
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame
Immediately after intervention
Title
Cambridge neuropsychological test automated battery (CANTAB)
Time Frame
Immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A primary diagnosis of OCD, with a score > 16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (Goodman et al, 1989b, 1006-1011).
Participants must be aged older than 18 and younger than 65 years.
Right handed.
If taking SSRI's the participant needs to be on a stable dose for at least 2 months.
Exclusion Criteria:
Significant physical or neurological illnesses. An exception will be made for patients taking SSRI's (and not using any other drugs).
Any significant current DSM disorder (in addition to OCD).
Past history of significant substance or alcohol abuse.
Pregnancy.
Any metal pins/ prostheses or cardiac pacemakers.
Sufferers of claustrophobia.
Head injury
Facility Information:
Facility Name
Stellenbosch University
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Training in Obsessive Compulsive Disorder
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