NCT01638975

Brief Summary

This study tests a computerized cognitive training program designed for young individuals with compulsive hair pulling (also known as trichotillomania;TTM). Research suggests that individuals with TTM are characterized by poor cognitive abilities to suppress irrelevant response. This ability is called response inhibition. The current study tests a cognitive training program designed to improve individuals' cognitive abilities of response inhibition through a 8-session computerized training program. The investigators hypothesize that those who complete the response inhibition training program will show a greater reduction in hair pulling symptoms, compared to those assigned to a waitlist group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

June 16, 2012

Last Update Submit

January 17, 2014

Conditions

Trichotillomania

Outcome Measures

Primary Outcomes (3)

  • NIMH Trichotillomania Severity and Impairment Rating Scale

    This is one of the most widely clinician-interview based measure designed to assess the severity of hair pulling symptoms during the previous week. We administer this outcome measure at the baseline prior to the intervention.

    Baseline

  • NIMH Trichotillomania Severity and Impairment Rating Scale

    This primary outcome measure will be administered again at 4 week after completing the intervention or after completing the 1-month waiting period.

    4 week

  • NIMH Trichotillomania Severity and Impairment Rating Scale

    This primary outcome measure will be administered again at 8 week, which is designed for a 1-month follow-up assessment after completing the intervention.

    8 week

Secondary Outcomes (3)

  • Clinical Global Impression (CGI)

    Baseline

  • Clinical Global Impression (CGI)

    4 week

  • Clinical Global Impression (CGI)

    8 week

Study Arms (2)

Computerized response inhibition training

EXPERIMENTAL

Participants in this condition receive 8 computerized training sessions over a 4 week period.

Behavioral: Response Inhibition Training Program

Waitlist Control

NO INTERVENTION

Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment).

Interventions

Response Inhibition Training ProgramBEHAVIORAL

This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.

Computerized response inhibition training

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 9 and 17
  • A primary diagnosis of Trichotillomania based on DSM-IV criteria (using Trichotillomania Diagnostic Interview)

You may not qualify if:

  • those who are actively psychotic
  • those who have visual impairments that prevent them from performing computer tasks
  • those who present developmental disabilities and/or low overall IQ estimated to be below low average (\< 79)
  • those whose medication status has not been stable
  • those who present with past/current substance abuse/dependence problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (1)

  • Lee HJ, Espil FM, Bauer CC, Siwiec SG, Woods DW. Computerized response inhibition training for children with trichotillomania. Psychiatry Res. 2018 Apr;262:20-27. doi: 10.1016/j.psychres.2017.12.070. Epub 2018 Jan 5.

    PMID: 29407564DERIVED

MeSH Terms

Conditions

Trichotillomania

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 16, 2012

First Posted

July 12, 2012

Study Start

October 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)