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Trichotillomania (Hair-Pulling Disorder)Phase 1NCT04455152

Self-control and Body-focused Repetitive Behaviors

A Phase 1 study of Trichotillomania (Hair-Pulling Disorder) and Skin-Picking, run by American University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Web-based self-help could work well to disseminate behavior therapies for body-focused repetitive behaviors (BFRB) such as hair pulling and skin picking. Previous research suggests that this method works well for people who use the program a great deal, but many participants do not. Read more about this study

Who is it for?
Ages 18 years and older
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
30 Jun 2020to 4 Nov 2022
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • meet the diagnostic criteria for either Hair Pulling Disorder (trichotillomania) or Skin Picking Disorder
  • have regular access to the Internet
  • age 18 or older

Who cannot join

  • [all current, not lifetime]
  • suicidal thoughts
  • major depression
  • psychosis
  • severe anxiety
  • substance abuse.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • American University

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: Self-control Intervention to Increase Adherence to Web-based Self-help for Body-focused Repetitive Behaviors

Web-based self-help could work well to disseminate behavior therapies for body-focused repetitive behaviors (BFRB) such as hair pulling and skin picking. Previous research suggests that this method works well for people who use the program a great deal, but many participants do not. Adhering frequently to a BFRB self-help program requires self-control because the costs occur immediately (time, trouble, possible boredom), whereas the benefits (reduced symptoms) are realized later.

This study will test whether two weeks of practice of a self-control exercise (avoiding consumption of sweet foods), compared to wait list, will increase adherence during a subsequent 10-week trial of BFRB self-help.

Read the detailed description

Body-focused repetitive behaviors (BFRB) such as hair pulling and skin picking are prevalent and associated with distress and impairment. Behavioral treatments of BFRB are effective, but access to therapists with expertise in them is limited. One way to reduce the access problem is to disseminate evidence-based treatments in the form of web-based self-help programs. Behavior therapy methods are incorporated in such programs for hair pulling and skin picking, each of which appears promising based on uncontrolled studies. The investigators conducted the first randomized controlled trial of stop pulling.com. Compared to wait list, those with access to the program showed a small but significant advantage in reduction of interviewer-rated TTM symptoms. However, there was no significant difference from wait list on self-reported symptoms, alopecia [hair loss severity], impairment, or quality of life.

Average outcomes of stop pulling.com were thus modest, but the investigators see a couple of ways to extend this work in the proposed project. First, the coverage of BFRB is expanded by including stop picking.com. Second, web-based self-help will be tested as a free-standing intervention, the way it is offered to the public. In the previous research, stop pulling.com was the first phase of a stepped care program, to be followed [if desired] by in-person therapy. This could have biased the sample by limiting it to residents of the Washington, DC area and by attracting some who were not interested in web-based self-help and only wanted the in-person therapy. Consistent with this concern, 19% of participants never tried the self-help program. Third and most importantly, a preliminary self-control intervention intended to increase adherence to web-based self-help will be tested. Nonadherence is the main problem for self-help in behavioral health in general, and in BFRB in particular. In the earllier study of stop pulling.com, participants logged on and entered data on a median of just 12.5 days (out of the intended 70) in a 10-week span. Those who used it more tended to get more benefit, but the challenge is how to increase adherence overall.

Adherence to web-based self-help may be seen as requiring self-control because its costs are borne immediately (e.g., somewhat tedious assessments such as self-monitoring logs), whereas the benefits are probabilistic and delayed (reduction of symptoms over a period of weeks). Just as someone taking up a new exercise routine has to do something effortful and perhaps disagreeable at first in order to (likely) gain later benefits, so too the person with a BFRB needs to log data regarding urges or pulling/picking episodes in a meticulous manner in the hope of eventually getting useful individualized suggestions, implementing them, and (probably) reducing symptom severity. The method for improving self-control to be tested in this project derives from the "strength" model of self-control, in which willpower is considered analogous to a muscle. Research supports two key implications of this model, that exertion of self-control temporarily depletes capacity and impairs performance on other tasks (e.g., holding a hand grip as long as one can makes it harder to choose a healthy snack rather than chocolate), but that practicing self-control builds up self-control strength over time.

Approach: In this study 40 participants (20 hair pullers, 20 skin pickers-10 of each in each experimental condition) will be randomly assigned after a pretest of BFRB severity to one of two conditions: (a) 2-week self-control task vs. (b) 2-week wait list, followed in each condition by paid access to web-based self-help for 10 weeks and then post-test. The self-control intervention asks the participant to avoid eating sweet foods and to report via email each day how well they were able to do so. Smokers who performed this task were significantly better able to maintain abstinence after smoking cessation than were those in a control condition. The main dependent variable will be adherence, the number of days (out of 70) on which the participant logged in and entered data on their behavior. Secondary outcomes include change in BFRB symptoms and qualitative feedback on the self-control task and the self-help program.

Being tested
self-control
Medical subject headings
Trichotillomania, Excoriation Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-controlBehavioural

    avoiding eating sweets as a way of building self-control strength

Study groups in NCT04455152
Study groupRoleWhat they receive
Self-controlExperimentaltwo-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so
Receives: Behavioral: self-control
wait listNo interventionwaiting 2 weeks after baseline assessment before gaining access to web-based self-help

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    number of days (of maximum 70) on which participant logged into self-help program and entered data

    Measured: 10 weeks

Secondary outcomes (2)
  1. BFRB symptoms

    depending on participant's primary problem, either hairpulling or skin picking severity

    Measured: 12 weeks

  2. program feedback

    qualitative feedback on self-control task and on web-based self-help

    Measured: week 12 only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start30 Jun 2020
  3. Primary completion4 Nov 2022
  4. Study completion4 Nov 2022

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to self-control vs. wait list for 2 weeks after baseline assessment and before all receive 10 weeks of web-based self-help.
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04455152
Sponsor's protocol ID
Mellon2020CAS
Status last verified
Nov 2022
First submitted
29 Jun 2020
Last updated
7 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data could be shared with other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Trichotillomania (Hair-Pulling Disorder) and Skin-Picking, run by American University 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 6 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 7 Nov 2022. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Adherence (time frame: 10 weeks). 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 7 Nov 2022.

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