Online Response Inhibition Training for Trichotillomania

Trichotillomania Clinical Trial

— OTTM  

Official title:

Developing Online Response Inhibition Training for Individuals With Trichotillomania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984333
• Other study ID #: UWMRF-133
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: October 24, 2017
• Start date: November 2013
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Trichotillomania

Intervention

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.

Locations

Country	Name	City	State
United States	UWM Anxiety Disorders Laboratory	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on the Trichotillomania Scale for Children	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
Primary	Change on the NIMH Trichotillomania Severity and Impairment Scales	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	Change on the Clinical Global Impression Scale	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