Excoriation (Skin-Picking) DisorderNCT05989737
A RCT of an AEBT Website for Adults With Skin Picking
A study testing Acceptance-Enhanced Behavior Therapy in people with Excoriation (Skin-Picking) Disorder, run by Utah State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excoriation (Skin-Picking) Disorder
- What is being tested?
- Acceptance-Enhanced Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently meet criteria for DSM-5 excoriation disorder
- at least 18 years old at intake
- fluent in English
- reside in the United States
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Is the online intervention effective, compared to a waitlist control condition?
- Is the online intervention acceptable to use?
Read more
Participants will be randomized into either the online intervention or waitlist control condition:
- 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.
- 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.
Read the 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.
- Conditions
- Excoriation (Skin-Picking) Disorder
- Being tested
- Acceptance-Enhanced Behavior Therapy
- Keywords
- Acceptance and commitment therapy (ACT), Acceptance-enhanced behavioral training (AEBT)
- Medical subject headings
- Excoriation Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-Enhanced Behavior TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance-Enhanced Behavior Therapy |
| Waitlist control | No intervention | Waitlist condition; only assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start11 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excoriation (Skin-Picking) DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989737
- Sponsor's protocol ID
- 13693
- Status last verified
- Dec 2023
- First submitted
- 4 Aug 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a AEBT Website for Adults With Skin Picking
- ClinicalTrials.gov ID
- NCT05989737
- Acronym / sponsor ID
- 13693
- Conditions
- Excoriation (Skin-Picking) Disorder
- Keywords
- Acceptance and commitment therapy (ACT), Acceptance-enhanced behavioral training (AEBT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the online intervention effective, compared to a waitlist control condition?
- Is the online intervention acceptable to use?
Participants will be randomized into either the online intervention or waitlist control condition:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEBT online program | Experimental | Behavioral: Acceptance-Enhanced Behavior TherapyParticipants 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. |
| Waitlist control | No intervention | –Waitlist condition; only assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently meet criteria for DSM-5 excoriation disorder
- at least 18 years old at intake
- fluent in English
- reside in the United States
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance-Enhanced Behavior Therapy8-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). | Behavioural | AEBT online program |
Primary outcome
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.
5 secondary outcomes
Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)
Time frame: 12 weeks
Depression Anxiety Stress Scale (DASS-21)
Time frame: 12 weeks
Mental Health Continuum-Short Form (MHC-SF)
Time frame: 12 weeks
The System Usability Scale (SUS)
Time frame: 8 weeks
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-Enhanced Behavior Therapy in people with Excoriation (Skin-Picking) Disorder, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Picking Scale - Revised (SPS-R) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.