NCT01984333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

November 1, 2013

Last Update Submit

October 24, 2017

Conditions

Trichotillomania

Keywords

trichotillomaniaresponse inhibitioncognitive retraining

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change on the Clinical Global Impression Scale

    Baseline, 4 weeks, and 1-month Follow-up

Other Outcomes (1)

  • Change on the Trichotillomania Scale for Children

    Baseline, 4 weeks, and 1-month Follow-up

Study Arms (2)

Online cognitive training

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

This is a 1-month waitlist control to be compared with the active online cognitive training intervention. This is a no intervention control group.

Interventions

Online cognitive trainingBEHAVIORAL

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.

Online cognitive training

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Study Officials

  • Hanjoo Lee, Ph.D.

    University of Wisconsin, Milwaukee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 14, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)