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Online Response Inhibition Training for Trichotillomania (OTTM)

Primary Purpose

Trichotillomania

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online cognitive training
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring trichotillomania, response inhibition, cognitive retraining

Eligibility Criteria

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

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)

Sites / Locations

  • UWM Anxiety Disorders Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online cognitive training

Waitlist control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change on the Clinical Global Impression Scale
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.

Full Information

First Posted
November 1, 2013
Last Updated
October 24, 2017
Sponsor
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT01984333
Brief Title
Online Response Inhibition Training for Trichotillomania
Acronym
OTTM
Official Title
Developing Online Response Inhibition Training for Individuals With Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
trichotillomania, response inhibition, cognitive retraining

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online cognitive training
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
This is a 1-month waitlist control to be compared with the active online cognitive training intervention. This is a no intervention control group.
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on the NIMH Trichotillomania Severity and Impairment Scales
Description
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.
Time Frame
Baseline, 4 weeks, and 1-month Follow-up
Secondary Outcome Measure Information:
Title
Change on the Clinical Global Impression Scale
Description
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.
Time Frame
Baseline, 4 weeks, and 1-month Follow-up
Other Pre-specified Outcome Measures:
Title
Change on the Trichotillomania Scale for Children
Description
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.
Time Frame
Baseline, 4 weeks, and 1-month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanjoo Lee, Ph.D.
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
UWM Anxiety Disorders Laboratory
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

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Online Response Inhibition Training for Trichotillomania

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