A RCT of an AEBT Website for Adults With Skin Picking

Sponsor
Utah State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05989737
Collaborator
(none)
80
2
23.7

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test an online intervention for adults with excoriation disorder (skin picking). The main questions it aims to answer are:

  1. Is the online intervention effective, compared to a waitlist control condition?

  2. Is the online intervention acceptable to use?

Participants will be randomized into either the online intervention or waitlist control condition:

  1. Participants in the intervention condition will be asked to complete an 8 module acceptance-enhanced behavioral training (AEBT) program for skin picking and 4 surveys over 3 months.

  2. Participants in the waitlist condition will be asked to complete 4 surveys over 3 months, and will receive access to the intervention once the study is complete.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance-Enhanced Behavior Therapy
N/A

Detailed Description

Excoriation disorder, also known as skin picking, is a chronic repetitive condition that impacts an individual's daily functioning and causes clinically significant distress (Grant et al., 2012). Excoriation is estimated to impact between 2-5% (Grant & Chamberlain, 2020; Hayes et al., 2009) of the general population, although some studies have found up to 14% prevalence rates in undergraduate samples (Solley & Turner, 2018). Acceptance-enhanced behavioral training (AEBT; Twohig & Woods, 2023), has shown promising results for targeting skin picking symptoms (Asplund et al., 2021; Flessner et al., 2008). However, a recent study demonstrated that mental health providers have limited knowledge of skin picking and how to treat it effectively, creating a dearth of available treatment opportunities (Capel, Petersen, Woods, et al., 2023).

This study aims to address the gap in accessible evidence-based excoriation treatment by examining the efficacy and feasibility of a self-guided, online program based in AEBT. Participants will be recruited from across the United States from August to November 2023, and will be randomized into either the online intervention group or a waitlist control condition. All participants will complete online self-report assessments at baseline, mid-, post-intervention, and 1 month follow-up, and waitlist participants will be provided access to the program once the study is complete. For the primary aim evaluating efficacy, we predict that both primary (skin picking severity) and secondary outcomes (psychological flexibility, well-being, and distress) will be significantly improved in the active treatment condition compared to a waitlist control group. For the secondary aim evaluating feasibility, we predict that participants will report acceptable feasibility as measured through treatment adherence, reports of usability, and program feedback.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of a AEBT Website for Adults With Skin Picking
Anticipated Study Start Date :
Aug 11, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AEBT online program

Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT). Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy.

Behavioral: Acceptance-Enhanced Behavior Therapy
8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods & Twohig, 2008).

No Intervention: Waitlist control

Waitlist condition; only assessment

Outcome Measures

Primary Outcome Measures

  1. Skin Picking Scale - Revised (SPS-R) [12 weeks]

    The SPS-R is an 8-item self-report measure designed to assess skin picking severity over the past week. Items (e.g., "How often do you feel the urge to pick your skin?") are rated on a 5-point Likert Scale with total scores ranging from 0-32. Higher scores indicate greater skin picking severity.

Secondary Outcome Measures

  1. Acceptance and Action Questionnaire for Skin Picking (AAQ-SP) [12 weeks]

  2. Depression Anxiety Stress Scale (DASS-21) [12 weeks]

  3. Mental Health Continuum-Short Form (MHC-SF) [12 weeks]

  4. The System Usability Scale (SUS) [8 weeks]

  5. Treatment Evaluation Inventory-Short Form (TEI-SF) [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • currently meet criteria for DSM-5 excoriation disorder

  • at least 18 years old at intake

  • fluent in English

  • reside in the United States

Exclusion Criteria:
  • currently receiving alternative psychotherapy for skin picking

  • modifying or starting psychotropic medication 30 days prior to starting the study

  • currently living outside of the United States

  • under the age of 18

  • did not meet DSM-5 criteria for excoriation at the time of intake session

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Utah State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Twohig, Ph.D., Professor, Utah State University
ClinicalTrials.gov Identifier:
NCT05989737
Other Study ID Numbers:
  • 13693
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Twohig, Ph.D., Professor, Utah State University

Study Results

No Results Posted as of Aug 14, 2023