Clinical trial NCT05989737: A RCT of an AEBT Website for Adults With Skin Picking
Official title: A Randomized Controlled Trial of a AEBT Website for Adults With Skin Picking
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Excoriation (Skin-Picking) Disorder
Keywords: Acceptance and commitment therapy (ACT)
Acceptance-enhanced behavioral training (AEBT)
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Picking Scale - Revised (SPS-R)
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)
timeFrame: 12 weeks
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 12 weeks
measure: Mental Health Continuum-Short Form (MHC-SF)
timeFrame: 12 weeks
measure: The System Usability Scale (SUS)
timeFrame: 8 weeks
measure: Treatment Evaluation Inventory-Short Form (TEI-SF)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
References: