A RCT of an AEBT Website for Adults With Skin Picking

December 5, 2023 updated by: Michael Twohig, Ph.D., Utah State University

A Randomized Controlled Trial of a AEBT Website for Adults With Skin Picking

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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. Excoriation is estimated to impact between 2-5% of the general population, although some studies have found up to 14% prevalence rates in undergraduate samples. Acceptance-enhanced behavioral training (AEBT), has shown promising results for targeting skin picking symptoms. 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 .

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, the investigators 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, the investigators predict that participants will report acceptable feasibility as measured through treatment adherence, reports of usability, and program feedback.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Logan, Utah, United States, 84321
        • Utah State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Picking Scale - Revised (SPS-R)
Time Frame: 12 weeks
The Skin Picking Scale - Revised 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)
Time Frame: 12 weeks
The Acceptance and Action Questionnaire for Skin Picking is a 9-item (e.g., "I am able to not pick when the urge to pick is strong") self-report measure where items are rated from 1 (never true) to 7 (always true). Total scores range from 7-63 where lower scores indicate greater psychological flexibility around skin picking.
12 weeks
Depression Anxiety Stress Scale (DASS-21)
Time Frame: 12 weeks
The Depression Anxiety Stress Scale is a 21-item self-report measure that assess general distress with three subscales: depression, anxiety, and stress. Items (e.g., "I found it difficult to relax") are rated from 0 (never) to 3 (almost always) on a 4-point Likert scale. Sum scores are calculated by adding the subscale items and multiplying by two, so total scores range from 0 to 120, with higher scores indicating more distress.
12 weeks
Mental Health Continuum-Short Form (MHC-SF)
Time Frame: 12 weeks
The Mental Health Continuum Short Form is a 14-item self-report measure assessing emotional, social, and psychological well-being. Items (e.g., "During the past month, how often do you feel satisfied with life?") are rated from 0 (never) to 5 (everyday) on a 6-point Likert Scale. Total scores range from 0 to 70 where higher scores indicate greater levels of positive well-being.
12 weeks
The System Usability Scale (SUS)
Time Frame: 8 weeks
The System Usability Scale measures the usability of technology-based systems using a 10-item self-report measure. Items are rated from 1 (strongly disagree) to 5 (strongly agree), and items will be modified to refer to self-help website for excoriation. Scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100; higher scores indicate better usability.
8 weeks
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time Frame: 8 weeks
The TEI-SF assesses treatment acceptability using a 9-item self-report measure. One item will be modified to refer to "skin picking" rather than "anxiety", as done in previous studies. Items are rated from 1 (strongly disagree) to 5 (strongly agree); total scores range from 9-45 with higher scores indicating more positive treatment evaluation.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utah State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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