- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099537
Skin Picking Approach Avoidance Task (SPAAT)
Evaluating the Effect of Approach Avoidance Training on Action Tendencies for Individuals With Skin Picking Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Psychology Clinic, University of Wisconsin-Milwaukee
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Approach cognitive training
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.
|
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.
|
|
EXPERIMENTAL: Avoidance cognitive training
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.
|
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.
|
|
PLACEBO_COMPARATOR: Placebo cognitive training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre-training, Post-training (30-minutes after training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Urges to Pick After Training
Time Frame: Pre-training, Post-training (30-minutes 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.
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Pre-training, Post-training (30-minutes after training)
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Changes in scores on the Skin Picking Scale-Revised (SPS-R).
Time Frame: Pre-training, 2 weeks (follow-up)
|
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.
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Pre-training, 2 weeks (follow-up)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPAAT2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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