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Completed

NCT Number: NCT01984333

Online Response Inhibition Training for 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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Online Cognitive Training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Registry information

Official study title

Developing Online Response Inhibition Training for Individuals With Trichotillomania

Acronym: OTTM

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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