Obsessive Compulsive DisorderNCT02059980
Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania
A study testing Response inhibition training in people with Obsessive Compulsive Disorder and Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are characterized by the marked difficulty in inhibiting unwanted or inappropriate responses. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive Compulsive Disorder, Trichotillomania
- What is being tested?
- Response inhibition training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Principal diagnosis of obsessive-compulsive disorder or trichotillomania
Who cannot join
- Current substance use problems
- Current/Past Psychotic disorder, bipolar disorder, or schizophrenia
- Attention deficit/hyperactivity disorder or tic disorder
- Severe depressive symptoms
- Current psychotherapy
- Current suicidality
- Estimated intellectual functioning < 80
- Lack of response inhibition deficits on a stop-signal task
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
About this study
Official title: Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania
Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are characterized by the marked difficulty in inhibiting unwanted or inappropriate responses. There is compelling evidence that poor response inhibition is a core cognitive feature of OCD and its related disorders, but no effective intervention exists that directly attempts to address this problematic cognitive deficiency. This study will examine the feasibility and clinical utility of a computerized cognitive training program designed to improve response inhibition among individuals diagnosed with OCD or trichotillomania.This training program offers systematic practice of response inhibition in the form of a 40-level computer game. Individuals with these conditions will be randomized to either 8 sessions of (a) computerized response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize that RIT will outperform PLT in improving response inhibition capabilities and reducing relevant clinical symptoms. In sum, this project is expected to generate important knowledge to guide the development of effective computer-based treatment approaches that may help reduce critical problems of existing treatments such as suboptimal patient retention and treatment under-utilization, thereby improving overall treatment response rates among individuals suffering from OCD and related conditions.
- Conditions
- Obsessive Compulsive Disorder, Trichotillomania
- Being tested
- Response inhibition training, Placebo Control Training
- Keywords
- OCD, Trichotillomania, Response inhibition, Cognitive training
- Medical subject headings
- Obsessive-Compulsive Disorder, Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response inhibition trainingBehavioural
This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance
Placebo Control TrainingBehavioural
This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Response inhibition training | Experimental | Eight 45-minute sessions of computerized training on response inhibition over a 4 week period Receives: Behavioral: Response inhibition training |
| Placebo Control Training | Placebo comparator | Eight 45-minute sessions of computerized placebo control training over a 4 week period Receives: Behavioral: Placebo Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD, and a clinician-administered rating scale of hair pulling symptoms, widely used in clinical trial research for trichotillomania. Given the inclusion of two different diagnostic conditions, the primary outcome for the current study is the z score of the symptom rating severity obtained from the two rating scales, with higher values indicating greater symptom severity.
Measured: Baseline, Week 4, and Week 8
Stop Signal Reaction Time
Stop Signal Reaction Time (SSRT; time taken to complete the inhibitory process) is estimated using the tracking algorithm on the computerized stop-signal task, which adjusts the stop signal delay automatically (by 50ms) to maintain the rate of successful inhibition on stop-signal trials at 50%.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (2)
Clinical Global Impression Severity and Improvement
The Clinical Global Impression Severity and Improvement (CGI) is a clinician-administered rating scale widely used to assess the overall severity of the target condition in treatment outcome research. The CGI is assessed on a 7-point scale, with the severity scale from 1 (Normal, not at all ill) through to 7 (Among the most severely ill patients). Thus, the higher CGI severity rating score indicate a greater level of overall illness.
Measured: Baseline, Week 4, and Week 8
Commission Errors on the Go/No-go Task.
The number of commission errors on the go/no-go task is a commonly used measure of response inhibition. In this task, participants are asked to withhold their responses on no-go trials. If they fail to withhold their response in a no-go trial (i.e., pressing the response key to the no-go signal), this response counts toward the total number of commission errors. Therefore, a greater number of commission errors on this task reflects a greater level of inhibitory control deficit.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
- Investigators
- Han Joo Lee, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059980
- Sponsor's protocol ID
- R21-RIT_OC-LEE
- Other IDs
- R21MH094537
- Status last verified
- Aug 2018
- First submitted
- 7 Feb 2014
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania
- ClinicalTrials.gov ID
- NCT02059980
- Acronym / sponsor ID
- R21-RIT_OC-LEE
- Conditions
- Obsessive Compulsive Disorder, Trichotillomania
- Keywords
- OCD, Trichotillomania, Response inhibition, Cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are characterized by the marked difficulty in inhibiting unwanted or inappropriate responses. There is compelling evidence that poor response inhibition is a core cognitive feature of OCD and its related disorders, but no effective intervention exists that directly attempts to address this problematic cognitive deficiency. This study will examine the feasibility and clinical utility of a computerized cognitive training program designed to improve response inhibition among individuals diagnosed with OCD or trichotillomania.This training program offers systematic practice of response inhibition in the form of a 40-level computer game. Individuals with these conditions will be randomized to either 8 sessions of (a) computerized response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize that RIT will outperform PLT in improving response inhibition capabilities and reducing relevant clinical symptoms. In sum, this project is expected to generate important knowledge to guide the development of effective computer-based treatment approaches that may help reduce critical problems of existing treatments such as suboptimal patient retention and treatment under-utilization, thereby improving overall treatment response rates among individuals suffering from OCD and related conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Response inhibition training | Experimental | Behavioral: Response inhibition trainingEight 45-minute sessions of computerized training on response inhibition over a 4 week period |
| Placebo Control Training | Placebo comparator | Behavioral: Placebo Control TrainingEight 45-minute sessions of computerized placebo control training over a 4 week period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Principal diagnosis of obsessive-compulsive disorder or trichotillomania
Key exclusion criteria (8 listed)
- Current substance use problems
- Current/Past Psychotic disorder, bipolar disorder, or schizophrenia
- Attention deficit/hyperactivity disorder or tic disorder
- Severe depressive symptoms
- Current psychotherapy
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 |
|---|---|---|
| Response inhibition trainingThis is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance | Behavioural | Response inhibition training |
| Placebo Control TrainingThis placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities. | Behavioural | Placebo Control Training |
Primary outcome
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Time frame: Baseline, Week 4, and Week 8
This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD, and a clinician-administered rating scale of hair pulling symptoms, widely used in clinical trial research for trichotillomania. Given the inclusion of two different diagnostic conditions, the primary outcome for the current study is the z score of the symptom rating severity obtained from the two rating scales, with higher values indicating greater symptom severity.
Stop Signal Reaction Time
Time frame: Baseline, Week 4, and Week 8
Stop Signal Reaction Time (SSRT; time taken to complete the inhibitory process) is estimated using the tracking algorithm on the computerized stop-signal task, which adjusts the stop signal delay automatically (by 50ms) to maintain the rate of successful inhibition on stop-signal trials at 50%.
2 secondary outcomes
Clinical Global Impression Severity and Improvement
Time frame: Baseline, Week 4, and Week 8
Commission Errors on the Go/No-go Task.
Time frame: Baseline, Week 4, and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Han Joo Lee, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response inhibition training in people with Obsessive Compulsive Disorder and Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 26 Sep 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH) (time frame: Baseline, Week 4, and Week 8). 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 26 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.