Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04455152 |
| Other study ID # |
Mellon2020CAS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2020 |
| Est. completion date |
November 4, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
American University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
