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Response Inhibition Training for Individuals With Trichotillomania

Primary Purpose

Trichotillomania

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Response Inhibition Training Program
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychology Clinic, University of Wisconsin-Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computerized response inhibition training

Waitlist Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Clinical Global Impression (CGI)
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)
This measure will be administered at 4 week (after completing the training or 1-month waiting period).
Clinical Global Impression (CGI)
This measure will be administered at 8 week for a 1-month follow-up assessment to examine the longterm effect of the intervention.

Full Information

First Posted
June 16, 2012
Last Updated
January 17, 2014
Sponsor
University of Wisconsin, Milwaukee
Collaborators
Trichotillomania Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT01638975
Brief Title
Response Inhibition Training for Individuals With Trichotillomania
Official Title
Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
Trichotillomania Learning Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized response inhibition training
Arm Type
Experimental
Arm Description
Participants in this condition receive 8 computerized training sessions over a 4 week period.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment).
Intervention Type
Behavioral
Intervention Name(s)
Response Inhibition Training Program
Intervention Description
This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.
Primary Outcome Measure Information:
Title
NIMH Trichotillomania Severity and Impairment Rating Scale
Description
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.
Time Frame
Baseline
Title
NIMH Trichotillomania Severity and Impairment Rating Scale
Description
This primary outcome measure will be administered again at 4 week after completing the intervention or after completing the 1-month waiting period.
Time Frame
4 week
Title
NIMH Trichotillomania Severity and Impairment Rating Scale
Description
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.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
Baseline
Title
Clinical Global Impression (CGI)
Description
This measure will be administered at 4 week (after completing the training or 1-month waiting period).
Time Frame
4 week
Title
Clinical Global Impression (CGI)
Description
This measure will be administered at 8 week for a 1-month follow-up assessment to examine the longterm effect of the intervention.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Psychology Clinic, University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29407564
Citation
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.
Results Reference
derived

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Response Inhibition Training for Individuals With Trichotillomania

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