Trial record 6 of 25 for:    "Trichotillomania"

Online Response Inhibition Training for Trichotillomania (OTTM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Wisconsin, Milwaukee
Sponsor:
Information provided by (Responsible Party):
Han Joo Lee, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier:
NCT01984333
First received: November 1, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Trichotillomania
Behavioral: Online cognitive training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Online Response Inhibition Training for Individuals With Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Milwaukee:

Primary Outcome Measures:
  • Change on the NIMH Trichotillomania Severity and Impairment Scales [ Time Frame: Baseline, 4 weeks, and 1-month Follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change on the Clinical Global Impression Scale [ Time Frame: Baseline, 4 weeks, and 1-month Follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change on the Trichotillomania Scale for Children [ Time Frame: Baseline, 4 weeks, and 1-month Follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Online cognitive training
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
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.
No Intervention: Waitlist control
This is a 1-month waitlist control to be compared with the active online cognitive training intervention. This is a no intervention control group.

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984333

Contacts
Contact: Hanjoo Lee, Ph.D. 414-229-5858 leehj@uwm.edu

Locations
United States, Wisconsin
UWM Anxiety Disorders Laboratory Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Hanjoo Lee, Ph.D.         
Principal Investigator: Hanjoo Lee, Ph.D.         
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Hanjoo Lee, Ph.D. University of Wisconsin, Milwaukee
  More Information

No publications provided

Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT01984333     History of Changes
Other Study ID Numbers: UWMRF-133
Study First Received: November 1, 2013
Last Updated: February 10, 2014
Health Authority: USA: Institutional Review Board, University of Wisconsin-Milwaukee

Keywords provided by University of Wisconsin, Milwaukee:
trichotillomania
response inhibition
cognitive retraining

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014