TrichotillomaniaNCT01638975
Response Inhibition Training for Individuals With Trichotillomania
A study testing Response Inhibition Training Program in people with Trichotillomania, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Response Inhibition Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2013
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 9 and 17
- A primary diagnosis of Trichotillomania based on DSM-IV criteria (using Trichotillomania Diagnostic Interview)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
About this study
Official title: Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania
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.
Read the 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.
- Conditions
- Trichotillomania
- Being tested
- Response Inhibition Training Program
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response Inhibition Training ProgramBehavioural
This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Computerized response inhibition training | Experimental | Participants in this condition receive 8 computerized training sessions over a 4 week period. Receives: Behavioral: Response Inhibition Training Program |
| Waitlist Control | No intervention | Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 4 week
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.
Measured: 8 week
Secondary outcomes (3)
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.
Measured: Baseline
Clinical Global Impression (CGI)
This measure will be administered at 4 week (after completing the training or 1-month waiting period).
Measured: 4 week
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638975
- Sponsor's protocol ID
- TLC 2010 Lee
- Status last verified
- Jan 2014
- First submitted
- 16 Jun 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29407564
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Response Inhibition Enhancement Training for Individuals With Trichotillomania
- ClinicalTrials.gov ID
- NCT01638975
- Acronym / sponsor ID
- TLC 2010 Lee
- Conditions
- Trichotillomania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jul 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized response inhibition training | Experimental | Behavioral: Response Inhibition Training ProgramParticipants in this condition receive 8 computerized training sessions over a 4 week period. |
| Waitlist Control | No intervention | –Participants assigned to this condition wait without an intervention until the second assessment (4 weeks after the baseline assessment). |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged between 9 and 17
- A primary diagnosis of Trichotillomania based on DSM-IV criteria (using Trichotillomania Diagnostic Interview)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Response Inhibition Training ProgramThis is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period. | Behavioural | Computerized response inhibition training |
Primary outcome
NIMH Trichotillomania Severity and Impairment Rating Scale
Time frame: Baseline
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
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
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.
3 secondary outcomes
Clinical Global Impression (CGI)
Time frame: Baseline
Clinical Global Impression (CGI)
Time frame: 4 week
Clinical Global Impression (CGI)
Time frame: 8 week
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 20 Jan 2014.
- Derived from this study: PubMed 29407564Lee 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response Inhibition Training Program 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 2 inclusion and 5 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 20 Jan 2014. 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?
NIMH Trichotillomania Severity and Impairment Rating Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01638975, which also lists 1 linked publication.
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 20 Jan 2014.