TrichotillomaniaOTTMNCT01984333
Online Response Inhibition Training for Trichotillomania
A study testing Online cognitive training in people with Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Online cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 8 and 17
- a diagnosis of trichotillomania
- a computer with high speed internet
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UWM Anxiety Disorders Laboratory
Milwaukee, Wisconsin, 53211
About this study
Official title: 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.
Read the 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.
- Conditions
- Trichotillomania
- Being tested
- Online cognitive training
- Keywords
- trichotillomania, response inhibition, cognitive retraining
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online cognitive training | Experimental | 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. Receives: Behavioral: Online cognitive training |
| Waitlist control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, and 1-month Follow-up
Secondary outcomes (1)
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.
Measured: Baseline, 4 weeks, and 1-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
- Investigators
- Hanjoo Lee, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984333
- Sponsor's protocol ID
- UWMRF-133
- Acronym
- OTTM
- Status last verified
- Oct 2017
- First submitted
- 1 Nov 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Online Response Inhibition Training for Individuals With Trichotillomania
- ClinicalTrials.gov ID
- NCT01984333
- Acronym / sponsor ID
- OTTM / UWMRF-133
- Conditions
- Trichotillomania
- Keywords
- trichotillomania, response inhibition, cognitive retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online cognitive training | Experimental | Behavioral: Online cognitive trainingOnline 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. |
| Waitlist control | No intervention | –This is a 1-month waitlist control to be compared with the active online cognitive training intervention. This is a no intervention control group. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 8 and 17
- a diagnosis of trichotillomania
- a computer with high speed internet
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online cognitive trainingOnline 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. | Behavioural | Online cognitive training |
Primary outcome
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.
1 secondary outcome
Change on the Clinical Global Impression Scale
Time frame: Baseline, 4 weeks, and 1-month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanjoo Lee, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive training in people with Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the NIMH Trichotillomania Severity and Impairment Scales (time frame: Baseline, 4 weeks, and 1-month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.