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Self-control and Body-focused Repetitive Behaviors

Primary Purpose

Trichotillomania (Hair-Pulling Disorder), Skin-Picking

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
self-control
Sponsored by
American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania (Hair-Pulling Disorder)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

[all current, not lifetime]

  • suicidal thoughts
  • major depression
  • psychosis
  • severe anxiety
  • substance abuse.

Sites / Locations

  • American University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-control

wait list

Arm Description

two-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so

waiting 2 weeks after baseline assessment before gaining access to web-based self-help

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

BFRB symptoms
depending on participant's primary problem, either hairpulling or skin picking severity
program feedback
qualitative feedback on self-control task and on web-based self-help

Full Information

First Posted
June 29, 2020
Last Updated
November 4, 2022
Sponsor
American University
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1. Study Identification

Unique Protocol Identification Number
NCT04455152
Brief Title
Self-control and Body-focused Repetitive Behaviors
Official Title
Self-control Intervention to Increase Adherence to Web-based Self-help for Body-focused Repetitive Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania (Hair-Pulling Disorder), Skin-Picking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
Random assignment will not be made, nor known to anyone, until informed consent process and baseline assessment are completed.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-control
Arm Type
Experimental
Arm Description
two-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so
Arm Title
wait list
Arm Type
No Intervention
Arm Description
waiting 2 weeks after baseline assessment before gaining access to web-based self-help
Intervention Type
Behavioral
Intervention Name(s)
self-control
Intervention Description
avoiding eating sweets as a way of building self-control strength
Primary Outcome Measure Information:
Title
Adherence
Description
number of days (of maximum 70) on which participant logged into self-help program and entered data
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
BFRB symptoms
Description
depending on participant's primary problem, either hairpulling or skin picking severity
Time Frame
12 weeks
Title
program feedback
Description
qualitative feedback on self-control task and on web-based self-help
Time Frame
week 12 only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet the diagnostic criteria for either Hair Pulling Disorder (trichotillomania) or Skin Picking Disorder have regular access to the Internet age 18 or older Exclusion Criteria: [all current, not lifetime] suicidal thoughts major depression psychosis severe anxiety substance abuse.
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data could be shared with other researchers
IPD Sharing Time Frame
a year after completion of data collection, available indefinitely
IPD Sharing Access Criteria
Any faculty member, or graduate student collaborating with a faculty member.

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Self-control and Body-focused Repetitive Behaviors

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