Response Inhibition Training for Individuals With Trichotillomania

This study has been completed.
Sponsor:
Collaborator:
Trichotillomania Learning Center
Information provided by (Responsible Party):
Han Joo Lee, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier:
NCT01638975
First received: June 16, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Trichotillomania
Behavioral: Response Inhibition Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania

Resource links provided by NLM:


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

Primary Outcome Measures:
  • NIMH Trichotillomania Severity and Impairment Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • NIMH Trichotillomania Severity and Impairment Rating Scale [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    This primary outcome measure will be administered again at 4 week after completing the intervention or after completing the 1-month waiting period.

  • NIMH Trichotillomania Severity and Impairment Rating Scale [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This is a clinician-administered rating scale that is widely used in clinical outcome research to evaluate treatment outcomes with respect to overall levels of severity and improvement.

  • Clinical Global Impression (CGI) [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    This measure will be administered at 4 week (after completing the training or 1-month waiting period).

  • Clinical Global Impression (CGI) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    This measure will be administered at 8 week for a 1-month follow-up assessment to examine the longterm effect of the intervention.


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized response inhibition training
Participants in this condition receive 8 computerized training sessions over a 4 week period.
Behavioral: Response Inhibition Training Program
This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.
No Intervention: Waitlist Control
Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment).

Detailed Description:

Despite ongoing research into causes and treatments for trichotillomania, it remains poorly understood, underdiagnosed and inadequately treated. Further, treatment of TTM in children has received little attention, and only recently have the investigators begun to see research in pediatric trich. One possible way of progressing treatment development for pediatric trich is to clarify the nature of inhibitory control processes implicated in TTM and to develop a treatment that specifically targets these implicated cognitive processes. Examples of this strategy are found in the increasing availability of translational research that has demonstrated the therapeutic benefits of computerized cognitive training programs (CTPs) in modifying problematic cognitive processes in numerous psychiatric conditions. The objective of this study is to examine the feasibility of CTP for enhancing response inhibition capabilities among individuals with trich, thereby reducing TTM symptoms.

To this end, young individuals aged between 12 and 18 with TTM will be randomly assigned to the CTP condition vs. a wait-list condition. Participants in the CTP condition will receive eight 30-min training sessions over a 4-week period and will be assessed at three time points. Participants in the wait-list will be evaluated at baseline and post-training assessments, and will be allowed to receive the CTP after completing the post-training assessment. Wait-list controls who choose to cross over to the CTP condition will also provide a small replication sample to test the effect of our response inhibition training.

There are three primary implications from this work. First, demonstrating successful enhancement in response inhibition by our proposed CTP is expected to create ample opportunities for clinical research not only on TTM, but also for numerous other psychiatric problems in which poor response inhibition is implicated (e.g., Chronic Skin Picking, Tourette Syndrome, OCD, and ADHD).

This research has the potential to produce a highly cost-efficient self-administered intervention for TTM. Upon establishing efficacy, CTPs may be easily integrated into various contexts, examples include CTPs as an adjunctive intervention to existing behavioral and/or pharmacological treatments, an instrument to identify and help at-risk individuals for preventative training, a stand-alone short-term intervention, and a remote web-based self-help intervention for individuals who have no easy access to treatment resources or are reluctant to seek treatment.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT01638975

Locations
United States, Wisconsin
Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Trichotillomania Learning Center
  More Information

No publications provided

Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT01638975     History of Changes
Other Study ID Numbers: TLC 2010 Lee
Study First Received: June 16, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014