Trial Outcomes & Findings for Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania (NCT NCT02059980)
NCT ID: NCT02059980
Last Updated: 2018-09-26
Results Overview
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.
COMPLETED
NA
45 participants
Baseline, Week 4, and Week 8
2018-09-26
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania
Baseline characteristics by cohort
| Measure |
Response Inhibition Training
n=18 Participants
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
|
Placebo Control Training
n=15 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.17 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
24.47 years
STANDARD_DEVIATION 5.48 • n=7 Participants
|
28.67 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Depression Anxiety and Stress - 21
|
27.56 units on a scale
STANDARD_DEVIATION 24.08 • n=5 Participants
|
29.73 units on a scale
STANDARD_DEVIATION 17.00 • n=7 Participants
|
28.55 units on a scale
STANDARD_DEVIATION 20.88 • n=5 Participants
|
|
Obsessive-Compulsive Inventory-Revised
|
20.61 units on a scale
STANDARD_DEVIATION 16.96 • n=5 Participants
|
19.60 units on a scale
STANDARD_DEVIATION 12.57 • n=7 Participants
|
20.15 units on a scale
STANDARD_DEVIATION 14.91 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 8Population: 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.
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.
Outcome measures
| Measure |
Response Inhibition Training
n=18 Participants
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
|
Placebo Control Training
n=15 Participants
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.
|
|---|---|---|
|
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Baseline
|
-.38 z scores
Standard Deviation 1.13
|
.46 z scores
Standard Deviation .51
|
|
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Week 4
|
-.89 z scores
Standard Deviation 1.83
|
-.52 z scores
Standard Deviation 1.20
|
|
Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Week 8
|
-1.20 z scores
Standard Deviation 2.03
|
-.71 z scores
Standard Deviation 1.68
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 8Stop 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%.
Outcome measures
| Measure |
Response Inhibition Training
n=18 Participants
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
|
Placebo Control Training
n=15 Participants
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.
|
|---|---|---|
|
Stop Signal Reaction Time
Baseline
|
225.47 milliseconds
Standard Deviation 29.10
|
225.83 milliseconds
Standard Deviation 18.96
|
|
Stop Signal Reaction Time
Week 4
|
215.68 milliseconds
Standard Deviation 21.74
|
212.92 milliseconds
Standard Deviation 18.82
|
|
Stop Signal Reaction Time
Week 8
|
211.46 milliseconds
Standard Deviation 21.99
|
208.69 milliseconds
Standard Deviation 42.77
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8The 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.
Outcome measures
| Measure |
Response Inhibition Training
n=18 Participants
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
|
Placebo Control Training
n=15 Participants
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.
|
|---|---|---|
|
Clinical Global Impression Severity and Improvement
Baseline
|
3.67 score on a scale
Standard Deviation .69
|
4.00 score on a scale
Standard Deviation .54
|
|
Clinical Global Impression Severity and Improvement
Week 4
|
3.63 score on a scale
Standard Deviation .89
|
3.57 score on a scale
Standard Deviation .65
|
|
Clinical Global Impression Severity and Improvement
Week 8
|
3.20 score on a scale
Standard Deviation 1.01
|
3.69 score on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8The 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.
Outcome measures
| Measure |
Response Inhibition Training
n=18 Participants
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
|
Placebo Control Training
n=15 Participants
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.
|
|---|---|---|
|
Commission Errors on the Go/No-go Task.
Baseline
|
10.41 The number of commission errors
Standard Deviation 6.76
|
9.40 The number of commission errors
Standard Deviation 5.78
|
|
Commission Errors on the Go/No-go Task.
Week 4
|
10.69 The number of commission errors
Standard Deviation 5.75
|
15.64 The number of commission errors
Standard Deviation 8.90
|
|
Commission Errors on the Go/No-go Task.
Week 8
|
9.38 The number of commission errors
Standard Deviation 4.32
|
11.77 The number of commission errors
Standard Deviation 7.24
|
Adverse Events
Response Inhibition Training
Placebo Control Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place