AttentionATSNCT04097340
Attention Training on Smartphones
A study testing Attentional Bias Retraining (ABR) in people with Attention and Substance Use, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention, Substance Use
- What is being tested?
- Attentional Bias Retraining (ABR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 17 Jun 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Training on Smartphones (The ATS Study)
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.
Read the 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.
- Conditions
- Attention, Substance Use
- Being tested
- Attentional Bias Retraining (ABR), Control Training
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias Retraining (ABR)Device
Participants randomized to this intervention will receive 2 weeks of ABR for opioids delivered via a mobile device.
Control TrainingDevice
Participants randomized to this intervention will receive 2 weeks of training without ABR, delivered via a mobile device.
| Study group | Role | What they receive |
|---|---|---|
| Attentional Training Group | Active comparator | 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. Receives: Device: Attentional Bias Retraining (ABR) |
| Control Training Group | Placebo comparator | 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. Receives: Device: Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified System Usability Scale scores overall and comparisons between study conditions
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.
Measured: Post-two-week intervention period
Completion of daily assessments and attendance at study appointments.
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.
Measured: Two-week intervention period
Change in attentional bias (AB)
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.
Measured: Two-week intervention period
Secondary outcomes (7)
Change in craving levels
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.
Measured: Two-week intervention period
Change in opioid use
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
Measured: Two-week intervention period
Change in pain levels
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.
Measured: Two-week intervention period
Durability of retraining effect on attentional bias
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.
Measured: 1-month-follow-up
Durability of retraining effect on craving
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.
Measured: 1-month-follow-up
Durability of retraining effect on opioid use
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.
Measured: 1-month-follow-up
Durability of retraining effect on pain levels
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)
Measured: 1-month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Sep 2019
- Primary completion4 Aug 2021
- Study completion17 Jun 2023
Why it stopped: PI left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Leeman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097340
- Sponsor's protocol ID
- IRB201800947
- Other IDs
- OCR19813
- Acronym
- ATS
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2019
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training on Smartphones (The ATS Study)
- ClinicalTrials.gov ID
- NCT04097340
- Acronym / sponsor ID
- ATS / IRB201800947
- Conditions
- Attention, Substance Use
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left Institution
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 20 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attentional Training Group | Active comparator | Device: Attentional Bias Retraining (ABR)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. |
| Control Training Group | Placebo comparator | Device: Control TrainingEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Attentional Bias Retraining (ABR)Participants randomized to this intervention will receive 2 weeks of ABR for opioids delivered via a mobile device. | Device | Attentional Training Group |
| Control TrainingParticipants randomized to this intervention will receive 2 weeks of training without ABR, delivered via a mobile device. | Device | Control Training Group |
Primary outcome
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.
7 secondary outcomes
Change in craving levels
Time frame: Two-week intervention period
Change in opioid use
Time frame: Two-week intervention period
Change in pain levels
Time frame: Two-week intervention period
Durability of retraining effect on attentional bias
Time frame: 1-month-follow-up
Durability of retraining effect on craving
Time frame: 1-month-follow-up
Durability of retraining effect on opioid use
Time frame: 1-month-follow-up
Durability of retraining effect on pain levels
Time frame: 1-month-follow-up
Results and safety
The study was stopped early (reason given: PI left Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
Robert Leeman, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional Bias Retraining (ABR) in people with Attention and Substance Use, run by University of Florida 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Sep 2024. 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 was stopped early (reason given: PI left Institution). 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?
Modified System Usability Scale scores overall and comparisons between study conditions (time frame: Post-two-week intervention period). The study lists 3 primary outcomes in all. 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 3 Sep 2024.