Online Response Inhibition Training for Trichotillomania (OTTM)

October 24, 2017 updated by: Han Joo Lee, University of Wisconsin, Milwaukee

Developing Online Response Inhibition Training for Individuals With Trichotillomania

Trichotillomania (TTM) remains one of the most poorly-understood and inadequately-treated conditions. Research has shown poor response inhibition (RI; the ability to inhibit inappropriate but potent response) as an important cognitive feature of TTM. Investigators have developed a computerized training program that aims to improve RI. Fifty children with TTM will be randomly assigned to (a) online 8-session RI training (n=25), or (b) 1-month waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month follow-up. Investigators hypothesize that the online RIT will show greater improvement in TTM symptoms and RI capabilities at post-treatment and 1-month follow-up assessments, compared to the waitlist condition. This study will help develop an effective cognitive intervention program for TTM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although trichotillomania (TTM), an impulse control disorder characterized by compulsive hair pulling, typically results in serious consequences including impaired individual functioning, medical problems (e.g., skin infections), and elevated comorbidity with other psychiatric disorders, it remains one of the most poorly-understood and inadequately-treated psychiatric conditions. There is an urgent need for effective and accessible clinical interventions for TTM, especially for young individuals who suffer from a marked lack of adequate treatment resources despite the early onset of the condition. One promising therapeutic approach is to improve cognitive problems believed to contribute to TTM, using a computerized cognitive retraining method. Research has indicated impaired response inhibition (RI; the ability to inhibit inappropriate but potent response) as an important cognitive feature underlying TTM. Therefore, RI is considered to be an important target of cognitive retraining. Investigators have developed a computerized training program that aims to improve RI capabilities in the format of an online video game. Fifty children with TTM will be randomly assigned to (a) online 8-session RIT (n=25), or (b) 1-month waitlist condition (n = 25), and will be assessed at baseline, post-treatment, and 1-month follow-up. The waitlisted participants will also be invited to undergo the training program after the 1-month follow-up assessment is completed. Investigators hypothesize that the online RIT will show greater improvement in TTM symptoms and RI capabilities at post-treatment and 1-month follow-up assessments, compared to the waitlist condition. This study is expected to generate important data that will guide the development of an accessible, cost-efficient, and effective cognitive intervention for individuals suffering from TTM.

Study Type

Interventional

Enrollment (Actual)

54

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

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • UWM Anxiety Disorders Laboratory

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

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 8 and 17
  • a diagnosis of trichotillomania
  • a computer with high speed internet

Exclusion Criteria:

  • current substance use problems
  • current or past psychotic disorder, bipolar disorder, or schizophrenia
  • current behavioral treatments for trichotillomania
  • significant suicidality
  • severe conditions known for poor response inhibition(ADHD, OCD, and tic disorders)
  • recent or planned change in medication
  • low intellectual functioning (below 80)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online cognitive training
Online cognitive training will provides eight sessions of a computerized training game. Each session will last about 30-40 minutes, and participants will undergo 2 sessions each week over a 4-week period.
Behavioral: Online cognitive training
Online cognitive training is a web-based video game that offers systematic training of response inhibition capabilities. Participants will be guided to make progress in an individually-tailored fashion to master increasingly difficult game levels.
No Intervention: Waitlist control
This is a 1-month waitlist control to be compared with the active online cognitive training intervention. This is a no intervention control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the NIMH Trichotillomania Severity and Impairment Scales
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
These are clinician-rated measures for assessing the severity of trichotillomania and the impairment caused by hair pulling. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.
Baseline, 4 weeks, and 1-month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Clinical Global Impression Scale
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
This is a widely used brief assessment tool for evaluating illness severity, global improvement or change, and therapeutic response. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.
Baseline, 4 weeks, and 1-month Follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the Trichotillomania Scale for Children
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
This is a widely used self-report measure of hair pulling symptoms. Both the participant and parent will fill out this questionnaire at baseline, at 4 weeks, and at 1-month follow-up.
Baseline, 4 weeks, and 1-month Follow-up

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Milwaukee

Investigators

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

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

November 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWMRF-133

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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