Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania

• Sponsor: University of Wisconsin, Milwaukee (Other)
• Overall Status: Completed
• CT.gov ID: NCT02059980
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder; Trichotillomania	Behavioral: Response inhibition training; Behavioral: Placebo Control Training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Developing Effective Response Inhibition Training for Symptom Relief in Obsessive-Compulsive and Related Disorders and Trichotillomania
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Response inhibition training Eight 45-minute sessions of computerized training on response inhibition over a 4 week period	Behavioral: 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 Comparator: Placebo Control Training Eight 45-minute sessions of computerized placebo control training over a 4 week period	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH) [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.

2. Stop Signal Reaction Time [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%.

Secondary Outcome Measures

1. Clinical Global Impression Severity and Improvement [Baseline, Week 4, and Week 8]

   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.

2. Commission Errors on the Go/No-go Task. [Baseline, Week 4, and Week 8]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Principal diagnosis of obsessive-compulsive disorder or trichotillomania

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychology Clinic, University of Wisconsin-Milwaukee	Milwaukee	Wisconsin	United States	53211

Sponsors and Collaborators

• University of Wisconsin, Milwaukee
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Han Joo Lee, Ph.D., University of Wisconsin, Milwaukee

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2018

More Information

Publications

None provided.

• Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
• ClinicalTrials.gov Identifier: NCT02059980
• Other Study ID Numbers: R21-RIT_OC-LEE; R21MH094537
• First Posted: Feb 11, 2014
• Last Update Posted: Sep 26, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee: OCD; Trichotillomania; Response inhibition; Cognitive training
• Additional relevant MeSH terms: Obsessive-Compulsive Disorder; Trichotillomania

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Response Inhibition Training	Placebo Control Training
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	18	15
COMPLETED	16	14
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Response Inhibition Training	Placebo Control Training	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	18	15	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.17 (12.01)	24.47 (5.48)	28.67 (10.24)
Sex: Female, Male (Count of Participants)
Female	13 72.2%	13 86.7%	26 78.8%
Male	5 27.8%	2 13.3%	7 21.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 6.7%	1 3%
Not Hispanic or Latino	18 100%	14 93.3%	32 97%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5.6%	0 0%	1 3%
White	17 94.4%	14 93.3%	31 93.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 6.7%	1 3%
Region of Enrollment (Count of Participants)
United States	18 100%	15 100%	33 100%
Depression Anxiety and Stress - 21 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	27.56 (24.08)	29.73 (17.00)	28.55 (20.88)
Obsessive-Compulsive Inventory-Revised (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.61 (16.96)	19.60 (12.57)	20.15 (14.91)

Outcome Measures

1. Primary Outcome

Title	Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)
Description	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.
Time Frame	Baseline, Week 4, and Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Response Inhibition Training	Placebo Control Training
Arm/Group Description	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	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.
Measure Participants	18	15
Baseline	-.38 (1.13)	.46 (.51)
Week 4	-.89 (1.83)	-.52 (1.20)
Week 8	-1.20 (2.03)	-.71 (1.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Response Inhibition Training, Placebo Control Training
	Comments	It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	= 0.56
	Comments
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Stop Signal Reaction Time
Description	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%.
Time Frame	Baseline, Week 4, and Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Response Inhibition Training	Placebo Control Training
Arm/Group Description	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	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.
Measure Participants	18	15
Baseline	225.47 (29.10)	225.83 (18.96)
Week 4	215.68 (21.74)	212.92 (18.82)
Week 8	211.46 (21.99)	208.69 (42.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Response Inhibition Training, Placebo Control Training
	Comments	It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=.98
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Clinical Global Impression Severity and Improvement
Description	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.
Time Frame	Baseline, Week 4, and Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Response Inhibition Training	Placebo Control Training
Arm/Group Description	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	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.
Measure Participants	18	15
Baseline	3.67 (.69)	4.00 (.54)
Week 4	3.63 (.89)	3.57 (.65)
Week 8	3.20 (1.01)	3.69 (.75)

4. Secondary Outcome

Title	Commission Errors on the Go/No-go Task.
Description	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.
Time Frame	Baseline, Week 4, and Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Response Inhibition Training	Placebo Control Training
Arm/Group Description	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	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.
Measure Participants	18	15
Baseline	10.41 (6.76)	9.40 (5.78)
Week 4	10.69 (5.75)	15.64 (8.90)
Week 8	9.38 (4.32)	11.77 (7.24)

Adverse Events

Time Frame	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.
Arm/Group Title	Response Inhibition Training		Placebo Control Training
Arm/Group Description	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		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.
All Cause Mortality
	Response Inhibition Training		Placebo Control Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/15 (0%)
Serious Adverse Events
	Response Inhibition Training		Placebo Control Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Response Inhibition Training		Placebo Control Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.