Clinical trial NCT01984333: Online Response Inhibition Training for Trichotillomania
Official title: Developing Online Response Inhibition Training for Individuals With Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Keywords: trichotillomania
response inhibition
cognitive retraining
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change on the NIMH Trichotillomania Severity and Impairment Scales
timeFrame: Baseline, 4 weeks, and 1-month Follow-up
Secondary outcomes:
measure: Change on the Clinical Global Impression Scale
timeFrame: Baseline, 4 weeks, and 1-month Follow-up
Other outcomes:
measure: Change on the Trichotillomania Scale for Children
timeFrame: Baseline, 4 weeks, and 1-month Follow-up
Locations:
city: Milwaukee
country: United States
facility: UWM Anxiety Disorders Laboratory
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Hanjoo Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: