Self-control and Body-focused Repetitive Behaviors

NCT04455152 | Completed Phase 1

• 1 other identifier: Mellon2020CAS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania (Hair-Pulling Disorder); Skin-Picking

Outcome Measures

Primary Outcomes (1)

• Adherence

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

  10 weeks

Secondary Outcomes (2)

• BFRB symptoms

  12 weeks

• program feedback

  week 12 only

Study Arms (2)

Self-control

EXPERIMENTAL

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

Behavioral: self-control

wait list

NO INTERVENTION

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

Interventions

self-control BEHAVIORAL

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

Self-control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• American University: lead

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Trichotillomania; Excoriation Disorder

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Random assignment will not be made, nor known to anyone, until informed consent process and baseline assessment are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: June 30, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: a year after completion of data collection, available indefinitely
• Access Criteria: Any faculty member, or graduate student collaborating with a faculty member.

Locations

US (1)