A RCT of an AEBT Website for Adults With Skin Picking

Excoriation (Skin-Picking) Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05989737
• Other study ID #: 13693
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 11, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: December 2023
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Excoriation (Skin-Picking) Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Utah State University	Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Picking Scale - Revised (SPS-R)	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	Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)	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
Secondary	Depression Anxiety Stress Scale (DASS-21)	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
Secondary	Mental Health Continuum-Short Form (MHC-SF)	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
Secondary	The System Usability Scale (SUS)	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
Secondary	Treatment Evaluation Inventory-Short Form (TEI-SF)	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