- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01638975
Response Inhibition Training for Individuals With Trichotillomania
Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite ongoing research into causes and treatments for trichotillomania, it remains poorly understood, underdiagnosed and inadequately treated. Further, treatment of TTM in children has received little attention, and only recently have the investigators begun to see research in pediatric trich. One possible way of progressing treatment development for pediatric trich is to clarify the nature of inhibitory control processes implicated in TTM and to develop a treatment that specifically targets these implicated cognitive processes. Examples of this strategy are found in the increasing availability of translational research that has demonstrated the therapeutic benefits of computerized cognitive training programs (CTPs) in modifying problematic cognitive processes in numerous psychiatric conditions. The objective of this study is to examine the feasibility of CTP for enhancing response inhibition capabilities among individuals with trich, thereby reducing TTM symptoms.
To this end, young individuals aged between 12 and 18 with TTM will be randomly assigned to the CTP condition vs. a wait-list condition. Participants in the CTP condition will receive eight 30-min training sessions over a 4-week period and will be assessed at three time points. Participants in the wait-list will be evaluated at baseline and post-training assessments, and will be allowed to receive the CTP after completing the post-training assessment. Wait-list controls who choose to cross over to the CTP condition will also provide a small replication sample to test the effect of our response inhibition training.
There are three primary implications from this work. First, demonstrating successful enhancement in response inhibition by our proposed CTP is expected to create ample opportunities for clinical research not only on TTM, but also for numerous other psychiatric problems in which poor response inhibition is implicated (e.g., Chronic Skin Picking, Tourette Syndrome, OCD, and ADHD).
This research has the potential to produce a highly cost-efficient self-administered intervention for TTM. Upon establishing efficacy, CTPs may be easily integrated into various contexts, examples include CTPs as an adjunctive intervention to existing behavioral and/or pharmacological treatments, an instrument to identify and help at-risk individuals for preventative training, a stand-alone short-term intervention, and a remote web-based self-help intervention for individuals who have no easy access to treatment resources or are reluctant to seek treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Psychology Clinic, University of Wisconsin-Milwaukee
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 9 and 17
- A primary diagnosis of Trichotillomania based on DSM-IV criteria (using Trichotillomania Diagnostic Interview)
Exclusion Criteria:
- those who are actively psychotic
- those who have visual impairments that prevent them from performing computer tasks
- those who present developmental disabilities and/or low overall IQ estimated to be below low average (< 79)
- those whose medication status has not been stable
- those who present with past/current substance abuse/dependence problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Computerized response inhibition training
Participants in this condition receive 8 computerized training sessions over a 4 week period.
|
This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.
|
NO_INTERVENTION: Waitlist Control
Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIMH Trichotillomania Severity and Impairment Rating Scale
Time Frame: Baseline
|
This is one of the most widely clinician-interview based measure designed to assess the severity of hair pulling symptoms during the previous week.
We administer this outcome measure at the baseline prior to the intervention.
|
Baseline
|
NIMH Trichotillomania Severity and Impairment Rating Scale
Time Frame: 4 week
|
This primary outcome measure will be administered again at 4 week after completing the intervention or after completing the 1-month waiting period.
|
4 week
|
NIMH Trichotillomania Severity and Impairment Rating Scale
Time Frame: 8 week
|
This primary outcome measure will be administered again at 8 week, which is designed for a 1-month follow-up assessment after completing the intervention.
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression (CGI)
Time Frame: Baseline
|
This is a clinician-administered rating scale that is widely used in clinical outcome research to evaluate treatment outcomes with respect to overall levels of severity and improvement.
|
Baseline
|
Clinical Global Impression (CGI)
Time Frame: 4 week
|
This measure will be administered at 4 week (after completing the training or 1-month waiting period).
|
4 week
|
Clinical Global Impression (CGI)
Time Frame: 8 week
|
This measure will be administered at 8 week for a 1-month follow-up assessment to examine the longterm effect of the intervention.
|
8 week
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLC 2010 Lee
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trichotillomania
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Johns Hopkins UniversityRecruitingTrichotillomania | Trichotillomania (Hair-Pulling Disorder) | Hair PullingUnited States
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University of ChicagoNot yet recruitingTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
-
University of ChicagoCompletedTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
-
University of ChicagoRecruitingTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
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American UniversityCompletedTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
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Yale UniversityNeurocrine BiosciencesRecruitingTrichotillomania (Hair-Pulling Disorder)United States
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HabitAware Inc.National Institute of Mental Health (NIMH); Marquette UniversityCompletedTrichotillomaniaUnited States
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University of Wisconsin, MilwaukeeCompleted
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University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedTrichotillomaniaUnited States
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University of Sao PauloCompleted
Clinical Trials on Response Inhibition Training Program
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Babes-Bolyai UniversityCompleted
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-
North Dakota State UniversityUnknown
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Karolinska InstitutetCompleted
-
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Massachusetts General HospitalUnknownStress | Burnout, ProfessionalUnited States
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