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.
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
- Conditions the study is for
- Trichotillomania (Hair-Pulling Disorder), Skin-Picking
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Self-control | Experimental | two-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so Receives: Behavioral: self-control |
| wait list | No intervention | waiting 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.
Adherence
number of days (of maximum 70) on which participant logged into self-help program and entered data
Measured: 10 weeks
Secondary outcomes (2)
BFRB symptoms
depending on participant's primary problem, either hairpulling or skin picking severity
Measured: 12 weeks
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.
- First posted2 Jul 2020
- Study start30 Jun 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichotillomania (Hair-Pulling Disorder)Studies 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 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)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. F. Haaga, American University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-control Intervention to Increase Adherence to Web-based Self-help for Body-focused Repetitive Behaviors
- ClinicalTrials.gov ID
- NCT04455152
- Acronym / sponsor ID
- Mellon2020CAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 2 Jul 2020 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-control | Experimental | Behavioral: self-controltwo-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so |
| wait list | No intervention | –waiting 2 weeks after baseline assessment before gaining access to web-based self-help |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet the diagnostic criteria for either Hair Pulling Disorder (trichotillomania) or Skin Picking Disorder
- have regular access to the Internet
- age 18 or older
Key exclusion criteria (6 listed)
- [all current, not lifetime]
- suicidal thoughts
- major depression
- psychosis
- severe anxiety
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 |
|---|---|---|
| self-controlavoiding eating sweets as a way of building self-control strength | Behavioural | Self-control |
Primary outcome
Adherence
Time frame: 10 weeks
number of days (of maximum 70) on which participant logged into self-help program and entered data
2 secondary outcomes
BFRB symptoms
Time frame: 12 weeks
program feedback
Time frame: week 12 only
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 7 Nov 2022.
- Individual participant dataSharing planned: Yes. De-identified data could be shared with other researchers
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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 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.