Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Attention Training on Smartphones (ATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097340
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04097340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • Change in craving levels [ Time Frame: Two-week intervention period ]
    Assess whether attentional bias retraining (ABR) reduces opioid craving to a greater extent than a control training condition based on self-report. Will be examined at each appointment and during the 2-week intervention on the smartphone app. The 14-item Heroin Craving Questionnaire-Short Form (HCQ-SF-14) will be used to measure current heroin/opioid urges at lab appointments, and two questions rated on 6-point Likert scales will be asked after every trial during the smartphone training period about participants current liking and wanting for opioids.
  • Change in opioid use [ Time Frame: Two-week intervention period ]
    Assess whether attentional bias retraining is associated with less opioid use during the training period than a control training condition based on self-report and urinalysis
  • Change in pain levels [ Time Frame: Two-week intervention period ]
    The Brief Pain Inventory Short Form (BPI-SF) will be used to measure levels of self-reported pain pre- and post-intervention. Participants will be asked to report daily pain levels during the 2-week intervention period. Self reported pain with the Brief Pain Inventory (BPI)-SF: Self-report questionnaire used to assess the severity of pain and the impact of pain on daily functions. There are 9 items asking participant to rate the worst, least, average, and current pain intensity. Participants are also asked to list current treatments and the perceived effectiveness, and asked to rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. The researchers will also ask participants to rate current pain levels, if participants have sought any relief from pain, and what was used to relieve the pain.
  • Durability of retraining effect on attentional bias [ Time Frame: 1-month-follow-up ]
    Examine the durability of any retraining effects on attentional bias compared to control training at 1-month follow-up. Reaction times from both the visual probe (VP) task and the drug Stroop task will be examined.
  • Durability of retraining effect on craving [ Time Frame: 1-month-follow-up ]
    Examine the durability of any retraining effects on self-reported craving compared to control training at 1-month follow-up. The 14-item Heroin Craving Questionnaire-Short Form (HCQ-SF-14) will be used to measure current heroin/opioid urges.
  • Durability of retraining effect on opioid use [ Time Frame: 1-month-follow-up ]
    Examine the durability of any retraining effects on opioid use compared to control training at 1-month follow-up based on self-report and urinalysis.
  • Durability of retraining effect on pain levels [ Time Frame: 1-month-follow-up ]
    Examine the durability of any retraining effects on self-reported pain compared to control training, measured with The Brief Pain Inventory Short Form (BPI-SF)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Attention Training on Smartphones
Official Title  ICMJE Attention Training on Smartphones (The ATS Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Attention
  • Substance Use
Intervention  ICMJE
  • Device: Attentional Bias Retraining (ABR)
    Participants randomized to this intervention will receive 2 weeks of ABR for opioids delivered via a mobile device.
  • Device: Control Training
    Participants randomized to this intervention will receive 2 weeks of training without ABR, delivered via a mobile device.
Study Arms  ICMJE
  • Active Comparator: Attentional Training Group
    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 participant nor the staff members working on the study will know which condition the participant has been randomly assigned to.
    Intervention: Device: Attentional Bias Retraining (ABR)
  • Placebo Comparator: Control Training Group
    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 participant nor the staff members working on the study will know which condition the participant has been randomly assigned to.
    Intervention: Device: Control Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to read and write in English
  • 6-week availability to participate in the study
  • Access to smartphone device: iphone 6 or newer model
  • Currently enrolled in a methadone maintenance program or taking buprenorphine or Suboxone as part of an opioid treatment program
  • Willing and able to answer questions on smartphones up to 4 times daily for about 10 minutes each time.

Exclusion Criteria:

  • Cognitive impairment
  • Drug use other than the ones included in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tessa Frohe 352-294-1026 tfrohe@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097340
Other Study ID Numbers  ICMJE IRB201800947
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Leeman, PhD University of Florida
PRS Account University of Florida
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP