Alcohol Use DisorderSmart-TNCT03746808
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults
A study testing EMA + App/Treatment Messages in people with Alcohol Use Disorder and Treatment, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Treatment, Homelessness
- What is being tested?
- EMA + App/Treatment Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Score ≥ 8 on the AUDIT
- Report consuming ≥ 1 drink of alcohol in the past week
- Receiving treatment at Metrocare;
- Willing and able to complete the baseline and follow-up visits;
- Score ≥ 4 on the REALM-SF, indicating > 6th grade English literacy level
- Score ≥ 24 on the Mini-Mental State Exam
Who cannot join
- Circulation problems, neuropathy, deep vein thrombosis, leg ulcers, tendonitis, diabetes, pregnancy, history of swelling or nickel or other metal allergies that would prohibit wearing the SCRAM ankle bracelet.
- Self-reported discomfort wearing an alcohol sensing bracelet for 4 weeks.
- Previously participated in Phase I (for Phase III recruitment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bridge Homeless Recovery Center
Dallas, Texas, 75201
About this study
Official title: Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention
Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.
Read the detailed description
An estimated 6.2% of US adults will be homeless at some point in their lifetime. Homeless adults have higher rates of disease, greater risk of interpersonal violence, shorter life expectancies, and disproportionately higher health care utilization and costs compared to housed individuals. A significant contributor to morbidity and mortality among homeless adults is the high prevalence of alcohol use. Approximately 33% of homeless adults have current alcohol dependence, a rate nearly 8 times that of the general population. Although shelter-based treatments are common, compliance is typically poor. Identifying factors that influence alcohol use would significantly improve the ability to develop effective interventions and engage homeless adults in treatment.
Relatively little is known about the environmental, cognitive, and behavioral antecedents of alcohol use in homeless adults. Like other subgroups, alcohol use has most often been examined using traditional lab/clinic based assessment methods that are not well suited to capturing the complicated street-level interactions experienced by most homeless adults. Traditional assessment methodologies may also provide biased and/or inaccurate estimates due to recall biases and errors in memory, particularly in this complicated population. Ecological momentary assessment (EMA), in which handheld devices (e.g., smartphones) are used to capture moment-to-moment experience, is currently the most accurate way to measure phenomena in natural settings. Additionally, recent technological advances have made it possible to collect continuous geolocation data alongside EMA. Researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone.
This pilot study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults enrolled in shelter-based treatment for an AUD. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use. Phase II will modify an existing app, previously validated for smoking cessation, to create the intervention. Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are enrolled in shelter-based treatment. Alcohol consumption will be validated via a transdermal alcohol sensor (i.e., SCRAM) worn by participants in Phases I and III.
The central hypothesis is that alcohol use is strongly affected by moment-to-moment risk and protective factors. This study will be able to use EMAs to identify and automatically intervene during moments when people are at high risk for drinking. This hypothesis is based on preliminary findings among homeless, justice-involved, and socioeconomically disadvantaged safety-net hospital patients. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with AUDs.
This project will:
- Use EMA to identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use among 80 homeless adults with an AUD who are receiving shelter-based treatment.
- Informed by Aim 1 findings, develop a "just-in-time" adaptive intervention to reduce alcohol use, including an alcohol use risk algorithm and corresponding theory-based treatment messages.
- Examine feasibility, acceptability, and preliminary effectiveness of a just-in-time adaptive smartphone app among 40 homeless adults with an AUD who are receiving shelter-based treatment.
- Conditions
- Alcohol Use Disorder, Treatment, Homelessness
- Being tested
- EMA + App/Treatment Messages
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA + App/Treatment MessagesBehavioural
This study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| EMA only | Placebo comparator | Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Receives: Behavioral: EMA + App/Treatment Messages |
| EMA + App/Treatment Messages | Active comparator | Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are receiving shelter-based treatment. The investigators will compare Phase III participants (i.e., received Metrocare, EMAs, and tailored treatment messages) to Phase I participants (i.e., received Metrocare and EMAs only) to examine the preliminary effectiveness of the app. Receives: Behavioral: EMA + App/Treatment Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With App Treatment Messages
Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)
Measured: 4 weeks
Secondary outcomes (2)
Number of Drinking Days
Number of drinking days (number of days with any self-reported drinking out of 28 days)
Measured: 4 weeks
Number of Heavy Drinking Days
Number of drinking days (number of days with self-reported >4 drinks for men; >3 drinks for women out of 28 days)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start14 Feb 2019
- Primary completion30 Jul 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Scott Walters, PhD, University of North Texas Health Science Center
- Investigators
- Scott Walters, PhD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746808
- Sponsor's protocol ID
- 1R34AA024584-01A1
- Acronym
- Smart-T
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2018
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walters ST, Mun EY, Tan Z, Luningham JM, Hebert ET, Oliver JA, Businelle MS. Development and preliminary effectiveness of a smartphone-based, just-in-time adaptive intervention for adults with alcohol misuse who are experiencing homelessness. Alcohol Clin Exp Res. 2022 Sep;46(9):1732-1741. doi: 10.1111/acer.14908. Epub 2022 Aug 7.
PubMed 35869820Walters ST, Businelle MS, Suchting R, Li X, Hebert ET, Mun EY. Using machine learning to identify predictors of imminent drinking and create tailored messages for at-risk drinkers experiencing homelessness. J Subst Abuse Treat. 2021 Aug;127:108417. doi: 10.1016/j.jsat.2021.108417. Epub 2021 Apr 20.
PubMed 34134874Mun EY, Li X, Businelle MS, Hebert ET, Tan Z, Barnett NP, Walters ST. Ecological Momentary Assessment of Alcohol Consumption and Its Concordance with Transdermal Alcohol Detection and Timeline Follow-Back Self-report Among Adults Experiencing Homelessness. Alcohol Clin Exp Res. 2021 Apr;45(4):864-876. doi: 10.1111/acer.14571. Epub 2021 Mar 3.
PubMed 33583057Businelle MS, Walters ST, Mun EY, Kirchner TR, Hebert ET, Li X. Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention. JMIR Res Protoc. 2020 Apr 16;9(4):e15610. doi: 10.2196/15610.
PubMed 32297874Tonkin SS, Chen M, Oliver JA, Walters ST, Gajos JM, Businelle MS. Daily variations and factors related to alcohol avoidance motivation and alcohol use among adults who are unhoused. Am J Drug Alcohol Abuse. 2026;52(2):270-281. doi: 10.1080/00952990.2026.2640488. Epub 2026 Apr 15.
PubMed 41984067
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention
- ClinicalTrials.gov ID
- NCT03746808
- Acronym / sponsor ID
- Smart-T / 1R34AA024584-01A1
- Conditions
- Alcohol Use Disorder, Treatment, Homelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.
Detailed description
An estimated 6.2% of US adults will be homeless at some point in their lifetime. Homeless adults have higher rates of disease, greater risk of interpersonal violence, shorter life expectancies, and disproportionately higher health care utilization and costs compared to housed individuals. A significant contributor to morbidity and mortality among homeless adults is the high prevalence of alcohol use. Approximately 33% of homeless adults have current alcohol dependence, a rate nearly 8 times that of the general population. Although shelter-based treatments are common, compliance is typically poor. Identifying factors that influence alcohol use would significantly improve the ability to develop effective interventions and engage homeless adults in treatment.
Relatively little is known about the environmental, cognitive, and behavioral antecedents of alcohol use in homeless adults. Like other subgroups, alcohol use has most often been examined using traditional lab/clinic based assessment methods that are not well suited to capturing the complicated street-level interactions experienced by most homeless adults. Traditional assessment methodologies may also provide biased and/or inaccurate estimates due to recall biases and errors in memory, particularly in this complicated population. Ecological momentary assessment (EMA), in which handheld devices (e.g., smartphones) are used to capture moment-to-moment experience, is currently the most accurate way to measure phenomena in natural settings. Additionally, recent technological advances have made it possible to collect continuous geolocation data alongside EMA. Researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone.
This pilot study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults enrolled in shelter-based treatment for an AUD. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use. Phase II will modify an existing app, previously validated for smoking cessation, to create the intervention. Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are enrolled in shelter-based treatment. Alcohol consumption will be validated via a transdermal alcohol sensor (i.e., SCRAM) worn by participants in Phases I and III.
The central hypothesis is that alcohol use is strongly affected by moment-to-moment risk and protective factors. This study will be able to use EMAs to identify and automatically intervene during moments when people are at high risk for drinking. This hypothesis is based on preliminary findings among homeless, justice-involved, and socioeconomically disadvantaged safety-net hospital patients. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with AUDs.
This project will:
- Use EMA to identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use among 80 homeless adults with an AUD who are receiving shelter-based treatment.
- Informed by Aim 1 findings, develop a "just-in-time" adaptive intervention to reduce alcohol use, including an alcohol use risk algorithm and corresponding theory-based treatment messages.
- Examine feasibility, acceptability, and preliminary effectiveness of a just-in-time adaptive smartphone app among 40 homeless adults with an AUD who are receiving shelter-based treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMA only | Placebo comparator | Behavioral: EMA + App/Treatment MessagesPhase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. |
| EMA + App/Treatment Messages | Active comparator | Behavioral: EMA + App/Treatment MessagesPhase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are receiving shelter-based treatment. The investigators will compare Phase III participants (i.e., received Metrocare, EMAs, and tailored treatment messages) to Phase I participants (i.e., received Metrocare and EMAs only) to examine the preliminary effectiveness of the app. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Score ≥ 8 on the AUDIT
- Report consuming ≥ 1 drink of alcohol in the past week
- Receiving treatment at Metrocare;
- Willing and able to complete the baseline and follow-up visits;
- Score ≥ 4 on the REALM-SF, indicating > 6th grade English literacy level
Key exclusion criteria (3 listed)
- Circulation problems, neuropathy, deep vein thrombosis, leg ulcers, tendonitis, diabetes, pregnancy, history of swelling or nickel or other metal allergies that would prohibit wearing the SCRAM ankle bracelet.
- Self-reported discomfort wearing an alcohol sensing bracelet for 4 weeks.
- Previously participated in Phase I (for Phase III recruitment).
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 |
|---|---|---|
| EMA + App/Treatment MessagesThis study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use. | Behavioural | EMA + App/Treatment Messages, EMA only |
Primary outcome
Satisfaction With App Treatment Messages
Time frame: 4 weeks
Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)
2 secondary outcomes
Number of Drinking Days
Time frame: 4 weeks
Number of Heavy Drinking Days
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35869820Walters ST, Mun EY, Tan Z, Luningham JM, Hebert ET, Oliver JA, Businelle MS. Development and preliminary effectiveness of a smartphone-based, just-in-time adaptive intervention for adults with alcohol misuse who are experiencing homelessness. Alcohol Clin Exp Res. 2022 Sep;46(9):1732-1741. doi: 10.1111/acer.14908. Epub 2022 Aug 7.
- Results publication: PubMed 34134874Walters ST, Businelle MS, Suchting R, Li X, Hebert ET, Mun EY. Using machine learning to identify predictors of imminent drinking and create tailored messages for at-risk drinkers experiencing homelessness. J Subst Abuse Treat. 2021 Aug;127:108417. doi: 10.1016/j.jsat.2021.108417. Epub 2021 Apr 20.
- Results publication: PubMed 33583057Mun EY, Li X, Businelle MS, Hebert ET, Tan Z, Barnett NP, Walters ST. Ecological Momentary Assessment of Alcohol Consumption and Its Concordance with Transdermal Alcohol Detection and Timeline Follow-Back Self-report Among Adults Experiencing Homelessness. Alcohol Clin Exp Res. 2021 Apr;45(4):864-876. doi: 10.1111/acer.14571. Epub 2021 Mar 3.
- Results publication: PubMed 32297874Businelle MS, Walters ST, Mun EY, Kirchner TR, Hebert ET, Li X. Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention. JMIR Res Protoc. 2020 Apr 16;9(4):e15610. doi: 10.2196/15610.
- Derived from this study: PubMed 41984067Tonkin SS, Chen M, Oliver JA, Walters ST, Gajos JM, Businelle MS. Daily variations and factors related to alcohol avoidance motivation and alcohol use among adults who are unhoused. Am J Drug Alcohol Abuse. 2026;52(2):270-281. doi: 10.1080/00952990.2026.2640488. Epub 2026 Apr 15.
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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.
Scott Walters, PhD principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA + App/Treatment Messages in people with Alcohol Use Disorder and Treatment, run by University of North Texas Health Science Center 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 6 inclusion and 3 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 18 Nov 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?
Yes. Results are posted in the registry (first posted 18 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Satisfaction With App Treatment Messages (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746808, which also lists 5 linked publications.
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 18 Nov 2022.