Response Inhibition Training for Individuals With Trichotillomania

January 17, 2014 updated by: Han Joo Lee, University of Wisconsin, Milwaukee

Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania

This study tests a computerized cognitive training program designed for young individuals with compulsive hair pulling (also known as trichotillomania;TTM). Research suggests that individuals with TTM are characterized by poor cognitive abilities to suppress irrelevant response. This ability is called response inhibition. The current study tests a cognitive training program designed to improve individuals' cognitive abilities of response inhibition through a 8-session computerized training program. The investigators hypothesize that those who complete the response inhibition training program will show a greater reduction in hair pulling symptoms, compared to those assigned to a waitlist group.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Psychology Clinic, University of Wisconsin-Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

June 16, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (ESTIMATE)

July 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

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.

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