Skin-PickingSPAATNCT04099537
Skin Picking Approach Avoidance Task
A study testing Computerized cognitive training in people with Skin-Picking, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
Pathological skin picking (PSP) is conceptualized as a behavioral addiction. Research has shown that behavioral addictions (e.g., problematic alcoholism or smoking) can be reduced using a cognitive retraining tool called approach-avoidance training (AAT). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Skin-Picking
- What is being tested?
- Computerized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 22 Jun 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A current diagnosis of skin picking
- Moderate symptoms of skin picking a Skin Picking Severity Scale (SPS) score of ≥ 7
- Ages 18-60,
- Fluent English speakers.
Who cannot join
- Self-reported visual impairment that cannot be adjusted and will prevent participants from clearly recognizing words and pictures on computer screen
- A positive diagnosis of bipolar disorder or psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
About this study
Official title: Evaluating the Effect of Approach Avoidance Training on Action Tendencies for Individuals With Skin Picking Disorder
Pathological skin picking (PSP) is conceptualized as a behavioral addiction. Research has shown that behavioral addictions (e.g., problematic alcoholism or smoking) can be reduced using a cognitive retraining tool called approach-avoidance training (AAT). Participants will be randomly assigned to a single-session of AAT: (a) approach training, (b) avoidance training, or (c) placebo training and will be assessed at baseline, post-training (i.e., 30 minutes after training), and 2-week follow up. The investigators hypothesize that those in the approach training will show greater reduction in approach tendencies at post-treatment and 2-week follow up, compared to those in the approach training or placebo conditions. This study may produce data that will guide the development of a training program that focuses on the maladaptive action tendencies in skin picking symptoms.
Read the detailed description
Pathological Skin Picking (PSP) is one of many debilitating Body Focused Repetitive Behaviors (BFRBs) that involves repetitive picking to gain the gratification of relieving anxiety or tension. Thus, this behavior may cause infections, lesions, and scarring, resulting in psychosocial impairment or medical attention. Because of the habitual/compulsive nature of the disorder, researchers conceptualize this maladaptive coping mechanism as a behavioral addiction which may occur without conscious awareness. Therefore, it is important to identify the automatic motivational orientations behind BFRBs. There is compelling evidence to suggest that a novel technological behavior paradigm, called Approach Avoidance Training (AAT), can be used to assess and modify action tendencies (i.e., approach or avoidance) in behavioral addictions like PSP. This game-like task has the participant push (=avoid) or pull (=approach) a joystick based on a target and control stimulus presented on a computer screen. This push-pull paradigm is in response to the individual's inherent action tendencies.
The overarching goal is to determine effective principles of change in interventions for BFRBs. Therefore, assessing neurocognitive components using computer-based training programs can help identify the implicit processes underlying the disorder. The objective of the study is to examine the feasibility of using AAT to modify PSP action tendencies, and potentially improve PSP symptoms. The investigators predict that individuals with PSP will have a pathological approach tendency towards skin as measured by the Approach-Avoidance Assessment (AAA). Therefore, AAT will promote reduction of approach to skin stimuli. To retrain one's action tendencies the investigators will randomize participants to the following training conditions: Avoidance Training (AvT; avoidance of skin stimuli), Approach Training (ApT; approach skin stimuli), or Placebo Training (PT; equal approach/avoidance of skin stimuli). The investigators will also administer an eye-tracking task to assess visual gaze response to pictures of irregular skin and neutral stimuli to evaluate training-induced changes in action tendencies. Previous studies have shown the AAT's success in reducing action tendencies and symptoms in other addictions like problematic alcohol use and cigarette smoking Therefore, AAT may prove effective in modifying the behavioral addiction of PSP. Sixty adults with PSP will be randomly assigned to (a) approach training (b) avoidance training or (c) placebo training. All participants will then be sent a follow-up survey approximately two weeks after completion of the main study to determine changes in symptoms. This pilot study is expected to guide the development of an accessible, cost-efficient, and effective cognitive training programs for individuals with PSP.
- Conditions
- Skin-Picking
- Being tested
- Computerized cognitive training
- Keywords
- skin picking, cognitive training, approach-avoidance
- Medical subject headings
- Excoriation Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingBehavioural
Participants are trained to approach or avoid stimuli of skin using a joystick. Participants are to pull or push the joystick toward or away when skin stimuli are present. Thus, behaviorally, there may be an increase, decrease, or no change in approach tendencies towards skin.
| Study group | Role | What they receive |
|---|---|---|
| Approach cognitive training | Experimental | This training is a single session training. Each session lasts about 30 minutes where participants are to pull the joystick toward (approach) them when seeing skin stimuli on a computer screen. Receives: Behavioral: Computerized cognitive training |
| Avoidance cognitive training | Experimental | This training is a single session training. Each session lasts about 30 minutes where participants are to push the joystick away (avoidance) from them when seeing skin stimuli on a computer screen. Receives: Behavioral: Computerized cognitive training |
| Placebo cognitive training | Placebo comparator | This training is a single session training. Each session lasts about 30 minutes where participants are to push and pull the joystick towards or away from them (no rule) when seeing skin stimuli on a computer screen. Receives: Behavioral: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Behavioral Approach Tendency After a Single Training Session
This assessment evaluates behavioral approach (i.e., reaction time to avoid - reaction to approach) to irregular skin stimuli before and after training (i.e., the AAT). The investigators will measure reaction time to approach irregular skin stimuli before training and then measure changes in reaction time to approach irregular skin stimuli immediately after training (i.e., post-training; defined as 30 minutes after training). The investigators will then average the reaction time for each group, and then evaluate statistical differences between groups.
Measured: Pre-training, Post-training (30-minutes after training)
Secondary outcomes (2)
Changes in Urges to Pick After Training
Evaluates urges to pick before and immediately after training (same-day post-training), using a behavioral approach task. Urges will be rated on a scale of 0 to 100, where 0 indicates no urges to pick and 100 indicates severe urges to pick. Participants will rate urges to pick for a total of 3 minutes and identify different areas where they feel the urge to pick. The investigators will then average the differences in urges within groups, and then evaluate statistical differences between groups.
Measured: Pre-training, Post-training (30-minutes after training)
Changes in scores on the Skin Picking Scale-Revised (SPS-R).
This 8-item scale measures skin picking severity (4 items) and impairment (4 items). The scale ranges from 0 to 32, where higher scores represent worse skin picking severity. Sub-scales ranges from 0 to 16, where the scores are summed to compute a total score.
Measured: Pre-training, 2 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start2 Jul 2018
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin-PickingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
- Investigators
- Han Joo Lee, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099537
- Sponsor's protocol ID
- SPAAT2018
- Acronym
- SPAAT
- Status last verified
- Feb 2022
- First submitted
- 9 Mar 2019
- Last updated
- 28 Feb 2022
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Approach Avoidance Training on Action Tendencies for Individuals With Skin Picking Disorder
- ClinicalTrials.gov ID
- NCT04099537
- Acronym / sponsor ID
- SPAAT / SPAAT2018
- Conditions
- Skin-Picking
- Keywords
- skin picking, cognitive training, approach-avoidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 23 Sep 2019 (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.
Pathological skin picking (PSP) is conceptualized as a behavioral addiction. Research has shown that behavioral addictions (e.g., problematic alcoholism or smoking) can be reduced using a cognitive retraining tool called approach-avoidance training (AAT). Participants will be randomly assigned to a single-session of AAT: (a) approach training, (b) avoidance training, or (c) placebo training and will be assessed at baseline, post-training (i.e., 30 minutes after training), and 2-week follow up. The investigators hypothesize that those in the approach training will show greater reduction in approach tendencies at post-treatment and 2-week follow up, compared to those in the approach training or placebo conditions. This study may produce data that will guide the development of a training program that focuses on the maladaptive action tendencies in skin picking symptoms.
Detailed description
Pathological Skin Picking (PSP) is one of many debilitating Body Focused Repetitive Behaviors (BFRBs) that involves repetitive picking to gain the gratification of relieving anxiety or tension. Thus, this behavior may cause infections, lesions, and scarring, resulting in psychosocial impairment or medical attention. Because of the habitual/compulsive nature of the disorder, researchers conceptualize this maladaptive coping mechanism as a behavioral addiction which may occur without conscious awareness. Therefore, it is important to identify the automatic motivational orientations behind BFRBs. There is compelling evidence to suggest that a novel technological behavior paradigm, called Approach Avoidance Training (AAT), can be used to assess and modify action tendencies (i.e., approach or avoidance) in behavioral addictions like PSP. This game-like task has the participant push (=avoid) or pull (=approach) a joystick based on a target and control stimulus presented on a computer screen. This push-pull paradigm is in response to the individual's inherent action tendencies.
The overarching goal is to determine effective principles of change in interventions for BFRBs. Therefore, assessing neurocognitive components using computer-based training programs can help identify the implicit processes underlying the disorder. The objective of the study is to examine the feasibility of using AAT to modify PSP action tendencies, and potentially improve PSP symptoms. The investigators predict that individuals with PSP will have a pathological approach tendency towards skin as measured by the Approach-Avoidance Assessment (AAA). Therefore, AAT will promote reduction of approach to skin stimuli. To retrain one's action tendencies the investigators will randomize participants to the following training conditions: Avoidance Training (AvT; avoidance of skin stimuli), Approach Training (ApT; approach skin stimuli), or Placebo Training (PT; equal approach/avoidance of skin stimuli). The investigators will also administer an eye-tracking task to assess visual gaze response to pictures of irregular skin and neutral stimuli to evaluate training-induced changes in action tendencies. Previous studies have shown the AAT's success in reducing action tendencies and symptoms in other addictions like problematic alcohol use and cigarette smoking Therefore, AAT may prove effective in modifying the behavioral addiction of PSP. Sixty adults with PSP will be randomly assigned to (a) approach training (b) avoidance training or (c) placebo training. All participants will then be sent a follow-up survey approximately two weeks after completion of the main study to determine changes in symptoms. This pilot study is expected to guide the development of an accessible, cost-efficient, and effective cognitive training programs for individuals with PSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Approach cognitive training | Experimental | Behavioral: Computerized cognitive trainingThis training is a single session training. Each session lasts about 30 minutes where participants are to pull the joystick toward (approach) them when seeing skin stimuli on a computer screen. |
| Avoidance cognitive training | Experimental | Behavioral: Computerized cognitive trainingThis training is a single session training. Each session lasts about 30 minutes where participants are to push the joystick away (avoidance) from them when seeing skin stimuli on a computer screen. |
| Placebo cognitive training | Placebo comparator | Behavioral: Computerized cognitive trainingThis training is a single session training. Each session lasts about 30 minutes where participants are to push and pull the joystick towards or away from them (no rule) when seeing skin stimuli on a computer screen. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A current diagnosis of skin picking
- Moderate symptoms of skin picking a Skin Picking Severity Scale (SPS) score of ≥ 7
- Ages 18-60,
- Fluent English speakers.
Key exclusion criteria (2 listed)
- Self-reported visual impairment that cannot be adjusted and will prevent participants from clearly recognizing words and pictures on computer screen
- A positive diagnosis of bipolar disorder or psychotic disorder
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 |
|---|---|---|
| Computerized cognitive trainingParticipants are trained to approach or avoid stimuli of skin using a joystick. Participants are to pull or push the joystick toward or away when skin stimuli are present. Thus, behaviorally, there may be an increase, decrease, or no change in approach tendencies towards skin. | Behavioural | Approach cognitive training, Avoidance cognitive training, Placebo cognitive training |
Primary outcome
Changes in Behavioral Approach Tendency After a Single Training Session
Time frame: Pre-training, Post-training (30-minutes after training)
This assessment evaluates behavioral approach (i.e., reaction time to avoid - reaction to approach) to irregular skin stimuli before and after training (i.e., the AAT). The investigators will measure reaction time to approach irregular skin stimuli before training and then measure changes in reaction time to approach irregular skin stimuli immediately after training (i.e., post-training; defined as 30 minutes after training). The investigators will then average the reaction time for each group, and then evaluate statistical differences between groups.
2 secondary outcomes
Changes in Urges to Pick After Training
Time frame: Pre-training, Post-training (30-minutes after training)
Changes in scores on the Skin Picking Scale-Revised (SPS-R).
Time frame: Pre-training, 2 weeks (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- 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.
Han Joo Lee, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training in people with Skin-Picking, run by University of Wisconsin, Milwaukee 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 2 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: finished, as of the sponsor's last update on 28 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Behavioral Approach Tendency After a Single Training Session (time frame: Pre-training, Post-training (30-minutes after training)). 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 28 Feb 2022.