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Clinical Trials/NCT04097340
NCT04097340
Active, not recruiting
Not Applicable

Attention Training on Smartphones (The ATS Study)

University of Florida1 site in 1 country24 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention
Sponsor
University of Florida
Enrollment
24
Locations
1
Primary Endpoint
Completion of daily assessments and attendance at study appointments.
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this study is to evaluate a new method that may influence attention, cravings and substance use called attention training, which will be delivered on a smartphone through an application (app). The study team would like to know what participants think of this new method and to determine if research involving this app is feasible. Eligible participants will use the app for a period of two weeks and attend a total of 4 appointments at our study location.

Detailed Description

The goal of this study is to evaluate a new method that may influence attention, cravings and substance use called attention training, which will be delivered on a smartphone through an application (app). The study team would like to know what participants think of this new method and to determine if research involving this app is feasible. Eligible participants will use the app for a period of two weeks and attend a total of 4 appointments at our study location. A primary aim of the study is to assess feasibility, usability and acceptability of mobile Attention Bias Retraining (ABR) by quantifying adherence (in lab and natural environment), self-reported ease of use, perceived value and likelihood of future use. Another primary aim of the study is to determine if ABR reduces attentional bias (AB) for opioids in those with Opioid Use Disorders (OUD) compared to a control training condition. A secondary aim of the study is to assess whether ABR reduces opioid craving to a greater extent than a control training condition based on self-report. Another secondary aim is to assess whether ABR is associated with less opioid use during the training period than a control training condition based on self-report and urinalysis. An exploratory aim of the study is to measure levels of self-reported pain pre- and post- ABR. Another exploratory aim is to examine the durability of ABR effect on AB/craving/ opioid use at 1-month follow-up. Interested individuals will first complete a in-person screening appointment including a medical and psychiatric screening and questionnaires covering topics including substance and alcohol use, cigarette smoking, and sexual behaviors. Eligible participants who enroll in the study will next complete an orientation appointment when study staff will teach participants how to use the study app and answer any questions that arise. Participants will then be randomly assigned (like a flip of a coin) to one of two conditions. Each condition involves use of a smartphone app. One smartphone app includes a task that targets attention directed to substance-related cues while the other app includes a similar task that does not target attention in this way. Neither the participants nor the staff members will know which condition the participant has been randomly assigned to. Participants will be informed of the assigned condition by study staff after the completion of the study. In most prior studies, attention training has been delivered on a desktop computer in a laboratory setting. Initial research has shown that attention training can be used in real-world settings using hand-held devices such as smartphones.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
June 17, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Able to read and write in English fluently and complete study evaluations
  • 6-week availability to participate in the study
  • Willing and able to answer questions on smartphones up to 4 times daily for about 10 minutes each time.
  • On Suboxone (or methadone if recruitment does not progress as planned) for at least one month (verified by urine drug test- unless using transdermal patch because 1/3 of patients using the patch will not show positive urine screen; and verified by opioid replacement therapy-provider)"
  • Meet DSM-5 criteria for opioid use disorder

Exclusion Criteria

  • Use (outside of prescription) for drugs that negatively interact with one another
  • Meet severe DSM-5 criteria for current substance use disorders other than opioids, nicotine or cannabis (e.g., current stimulant use disorder) and have used that substance within the past 30 days based on self-report or a positive urine drug test
  • Severe psychiatric conditions
  • Color blindness and/or uncorrected defective vision

Outcomes

Primary Outcomes

Completion of daily assessments and attendance at study appointments.

Time Frame: Two-week intervention period

Completion of a high percentage of smartphone assessments and attendance at appointments will show feasibility. Completion of 75% of assessments and attendance at 75% of study appointments will indicate feasibility.

Modified System Usability Scale scores overall and comparisons between study conditions

Time Frame: Post-two-week intervention period

Seven-point Likert scale items regarding the usability and acceptability of the app (higher score indicates greater usability and acceptability). Higher scores indicate greater usability and acceptability. The attentional bias retraining and control training conditions will also be compared on usability and acceptability scores.

Change in attentional bias (AB)

Time Frame: Two-week intervention period

Determine if attentional bias retraining reduces attentional bias for opioids compared to a control training condition. Reaction times from both the Visual probe (VP) task and the drug Stroop task will be examined to assess change in AB across time points.

Secondary Outcomes

  • Durability of retraining effect on craving(1-month-follow-up)
  • Durability of retraining effect on pain levels(1-month-follow-up)
  • Change in opioid use(Two-week intervention period)
  • Change in craving levels(Two-week intervention period)
  • Change in pain levels(Two-week intervention period)
  • Durability of retraining effect on attentional bias(1-month-follow-up)
  • Durability of retraining effect on opioid use(1-month-follow-up)

Study Sites (1)

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