Obsessive-Compulsive DisorderCTOCDNCT02818088
Cognitive Training in Obsessive Compulsive Disorder
A study testing n-Back (Cognitive Training) in people with Obsessive-Compulsive Disorder, run by University of Stellenbosch at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- n-Back (Cognitive Training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Training in Patients With Obsessive Compulsive Disorder
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- n-Back (Cognitive Training)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-Back (Cognitive Training)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Cognitive Training - n Back. Receives: Behavioral: n-Back (Cognitive Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Measured: Immediately after intervention
Cambridge neuropsychological test automated battery (CANTAB)
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: The app platform was cancelled and key personnel withdrew from the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Christine Lochner, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818088
- Sponsor's protocol ID
- S14/05/113
- Acronym
- CTOCD
- Status last verified
- May 2021
- First submitted
- 27 Jun 2016
- Last updated
- 6 May 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Patients With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02818088
- Acronym / sponsor ID
- CTOCD / S14/05/113
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The app platform was cancelled and key personnel withdrew from the project
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: n-Back (Cognitive Training)Cognitive Training - n Back. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-Back (Cognitive Training) | Behavioural | Cognitive Training |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Immediately after intervention
Cambridge neuropsychological test automated battery (CANTAB)
Time frame: Immediately after intervention
Results and safety
The study was stopped early (reason given: The app platform was cancelled and key personnel withdrew from the project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
Related trials for Obsessive-Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-Back (Cognitive Training) in people with Obsessive-Compulsive Disorder, run by University of Stellenbosch at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The app platform was cancelled and key personnel withdrew from the project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: Immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.