NCT05989737

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. 1.Is the online intervention effective, compared to a waitlist control condition?
  2. 2.Is the online intervention acceptable to use?
  3. 3.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.
  4. 4.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 11, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

August 4, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

Acceptance and commitment therapy (ACT)Acceptance-enhanced behavioral training (AEBT)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)

    12 weeks

  • Depression Anxiety Stress Scale (DASS-21)

    12 weeks

  • Mental Health Continuum-Short Form (MHC-SF)

    12 weeks

  • The System Usability Scale (SUS)

    8 weeks

  • Treatment Evaluation Inventory-Short Form (TEI-SF)

    8 weeks

Study Arms (2)

AEBT online program

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

Waitlist condition; only assessment

Interventions

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).

AEBT online program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • currently meet criteria for DSM-5 excoriation disorder
  • at least 18 years old at intake
  • fluent in English
  • reside in the United States

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84321, United States

Location

MeSH Terms

Conditions

Excoriation Disorder

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorObsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

August 11, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations