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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH094537 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Response inhibition training | Experimental | Eight 45-minute sessions of computerized training on response inhibition over a 4 week period |
|
| Placebo Control Training | Placebo Comparator | Eight 45-minute sessions of computerized placebo control training over a 4 week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Response inhibition training | Behavioral | This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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%. | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Joo Lee, Ph.D. | University of Wisconsin, Milwaukee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychology Clinic, University of Wisconsin-Milwaukee | Milwaukee | Wisconsin | 53211 | United States |
For this study, 258 individuals underwent online pre-screenings, and 83 participated in onsite full eligibility assessments. A total of 45 individuals met the study entry criteria, and were invited to the main study. Of them, 33 participants completed pre-training assessment and randomized into one of the two training conditions.
This study enrolled individuals diagnosed with obsessive-compulsive disorder or trichotillomania at a mid-west university in the United States. The last participant completed in August 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Response Inhibition Training | Eight 45-minute sessions of computerized training on response inhibition over a 4 week period Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance |
| FG001 | Placebo Control Training | Eight 45-minute sessions of computerized placebo control training over a 4 week period Placebo Control Training: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Response Inhibition Training | Eight 45-minute sessions of computerized training on response inhibition over a 4 week period Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population (all participants who received at least one session of training with a pre-training assessment). Last observation carried forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | z scores | Baseline, Week 4, and Week 8 |
|
The occurrence of adverse events were collected throughout the main assessment time points, including baseline, post-training, and 1-month follow-up assessments. Thus, the time window has been about 2 months for participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Response Inhibition Training | Eight 45-minute sessions of computerized training on response inhibition over a 4 week period Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Han Joo Lee | University of Wisconsin-Milwaukee | 414-229-5858 | leehj@uwm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2018 | Jul 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D014256 | Trichotillomania |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
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| Placebo Control Training | Behavioral | 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. |
|
| 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. | Baseline, Week 4, and Week 8 |
| Placebo Control Training |
Eight 45-minute sessions of computerized placebo control training over a 4 week period Placebo Control Training: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Depression Anxiety and Stress - 21 | The Depression Anxiety and Stress - 21 (DASS21) is a widely used questionnaire for assessment general emotional distress, including depression, anxiety, and stress symptoms. We examined the total score on the measure (range: 0 ~ 63), with the higher scores indicating a greater level of emotional distress. | Mean | Standard Deviation | units on a scale |
|
| Obsessive-Compulsive Inventory-Revised | The Obsessive-Compulsive Inventory-Revised (OCI-R) is a widely used self-report measure for assessing symptoms of OCD. The possible range of the total scores is 0 ~ 72. The table reports the total scores on the OCI-R, with higher scores indicating a greater level of OCD symptom severity. | Mean | Standard Deviation | units on a scale |
|
Eight 45-minute sessions of computerized training on response inhibition over a 4 week period
Response inhibition training: This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance
| OG001 | Placebo Control Training | Eight 45-minute sessions of computerized placebo control training over a 4 week period Placebo Control Training: 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. |
|
|
|
| Primary | 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%. | Posted | Mean | Standard Deviation | milliseconds | Baseline, Week 4, and Week 8 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, and Week 8 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | The number of commission errors | Baseline, Week 4, and Week 8 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo Control Training | Eight 45-minute sessions of computerized placebo control training over a 4 week period Placebo Control Training: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Week 8 |
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| Week 8 |
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| Week 8 |
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