Online Response Inhibition Training for Trichotillomania (OTTM)

October 24, 2017 updated by: Han Joo Lee, University of Wisconsin, Milwaukee

Developing Online Response Inhibition Training for Individuals With Trichotillomania

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • UWM Anxiety Disorders Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change on the NIMH Trichotillomania Severity and Impairment Scales
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
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.
Baseline, 4 weeks, and 1-month Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on the Clinical Global Impression Scale
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
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.
Baseline, 4 weeks, and 1-month Follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on the Trichotillomania Scale for Children
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
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.
Baseline, 4 weeks, and 1-month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Milwaukee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hanjoo Lee, Ph.D., University of Wisconsin, Milwaukee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UWMRF-133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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