Alcohol-Related DisordersMIRAPNCT03695653
Messaging Interventions to Reduce Alcohol Problems Project
A study testing Drink Tracking (MA), Adaptive Tailored (TA) and Tailored (TO) in people with Alcohol-Related Disorders and Alcohol Use Disorders, run by Partnership to End Addiction at 1 site in United States.
Trial summary
The study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking
- What is being tested?
- Drink Tracking (MA), Adaptive Tailored (TA) and Tailored (TO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 1 Nov 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be fluent and able to read in English at the eighth grade level;
- be between the ages of 21 and 75;
- have an estimated average weekly consumption of greater than 9 or 11 standard drinks per week for women and men, respectively OR at least two nights a week of drinking more than 4 drinks in one sitting for women and 5 drinks for men.
- be willing to reduce their drinking to non-hazardous levels;
- be willing to provide informed consent;
- own a mobile phone, have an active email address, are willing to receive and respond to up to 115 text messages total per month (average = 50); and
- give the name of a collateral who can be contacted in case of loss of contact or emergency.
Who cannot join
- present with significant substance use or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine), which is defined as greater than once weekly use in the past month/more than twice weekly use of marijuana;
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality;
- demonstrate clinically severe alcoholism, as evidenced by physical withdrawal symptoms or a history of serious withdrawal symptoms (e.g., hallucinations, seizures, or delirium tremens), and score greater than 12 on the Short Alcohol Withdrawal Scale (SAWS).
- report a medical condition that precludes drinking any alcohol; or
- demonstrate cognitive impairment as evidenced by a score of less than 7 out of 10 on the consent form quiz.
- express a desire to abstain or intent to obtain additional substance abuse treatment while in the study;
Trial locations and contacts
1 site in 1 country.
United States1 site
Partnership for Drug-Free Kids
New York, New York, 10010
About this study
Official title: Tailored Adaptive Mobile Messaging to Reduce Problem Drinking
The study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption.
According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence.
Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.
Read the detailed description
The study entitled, Tailored Adaptive Mobile Messaging to Reduce Problem Drinking (PD) is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption.
According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence.
Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.
The investigators recently completed an R34 study to develop the first automated tailored adaptive (TA) text messaging intervention for problem drinking (PD) adults (Muench et al. 2017). The study compared TA to different automated once a day static messaging including: tailored only messaging (TO), loss framed messaging (LF), gain frame messaging (GF), and weekly mobile assessment only (MA) over 12 weeks in 171 problem drinkers recruited on the internet across the US. All messaging groups outperformed MA on most drinking outcomes, and the TA group had the largest effect sizes on every drinking outcome, with an average weekly drink reduction of 9 standard drinks at week 12. Over an 8-month period, 1149 individuals across the country took the web-based screening survey, highlighting the demand for messaging in this population. Furthermore, 94.7% of participants (Ps) enrolled completed the end of messaging week 12 survey and 80% wanted to continue messaging following the pilot trial. There were no adverse events in this study.
Primary hypotheses:
- The TA group will have significantly reduced weekly sum of standard drinks (SSD) and heavy drinking days (HDD) compared to MA at all time periods.
- TO will have significantly reduced SSD and HDD compared to MA at all time points.
- TA group will have significantly reduced SSD compared to TO at all time periods except one month follow-up.
- Severity will moderate the relationship between TA, MA and TO and drinking in that high severity P's will make significantly greater changes in the TA group.
Exploratory aims include testing other outcomes such as drinking related consequences by group, moderators such as gender and ethnicity, and mediators such as intervention relevance and self-efficacy.
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Being tested
- Drink Tracking (MA), Adaptive Tailored (TA), Tailored (TO)
- Keywords
- Drinking, Alcohol Problems, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Problem Drinking, Text Message, Mobile Phone, Technology
- Medical subject headings
- Alcohol-Related Disorders, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink Tracking (MA)Behavioural
Weekly drink tracking for self-monitoring and assessment
Adaptive Tailored (TA)Behavioural
Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress
Tailored (TO)Behavioural
Messages are sent more frequently and tailored to some baseline characteristics
| Study group | Role | What they receive |
|---|---|---|
| Drink Tracking (MA) Condition | Active comparator | Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking. Receives: Behavioral: Drink Tracking (MA) |
| TA Intervention | Experimental | The TA intervention is tailored but will adapt over time too Receives: Behavioral: Adaptive Tailored (TA) |
| Tailored Content Only (TO) | Experimental | The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment. Receives: Behavioral: Tailored (TO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard drinks
Weekly sum of standard drinks (SSD)
Measured: 6 months
Heavy days
Heavy drinking days (HDD)
Measured: 6 months
Secondary outcomes (3)
Weekly drinking
Drinking days per week
Measured: 6 months
Daily drinking
Drinks per drinking day
Measured: 6 months
Consequences
Drinking related consequences
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start24 May 2019
- Primary completion18 Feb 2021
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Partnership to End Addiction
- Sponsor type
- University, hospital or other
- Collaborators
- Feinstein Institute for Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695653
- Sponsor's protocol ID
- 1R01AA025058
- Acronym
- MIRAP
- Status last verified
- Jul 2020
- First submitted
- 28 Sep 2018
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Adaptive Mobile Messaging to Reduce Problem Drinking
- ClinicalTrials.gov ID
- NCT03695653
- Acronym / sponsor ID
- MIRAP / 1R01AA025058
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Keywords
- Drinking, Alcohol Problems, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Problem Drinking, Text Message, Mobile Phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Partnership to End AddictionUniversity, hospital or other
- Collaborators
- Feinstein Institute for Medical Research
- Study start
- 24 May 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 4 Oct 2018 (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 study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption.
According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence.
Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.
Detailed description
The study entitled, Tailored Adaptive Mobile Messaging to Reduce Problem Drinking (PD) is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption.
According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence.
Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.
The investigators recently completed an R34 study to develop the first automated tailored adaptive (TA) text messaging intervention for problem drinking (PD) adults (Muench et al. 2017). The study compared TA to different automated once a day static messaging including: tailored only messaging (TO), loss framed messaging (LF), gain frame messaging (GF), and weekly mobile assessment only (MA) over 12 weeks in 171 problem drinkers recruited on the internet across the US. All messaging groups outperformed MA on most drinking outcomes, and the TA group had the largest effect sizes on every drinking outcome, with an average weekly drink reduction of 9 standard drinks at week 12. Over an 8-month period, 1149 individuals across the country took the web-based screening survey, highlighting the demand for messaging in this population. Furthermore, 94.7% of participants (Ps) enrolled completed the end of messaging week 12 survey and 80% wanted to continue messaging following the pilot trial. There were no adverse events in this study.
Primary hypotheses:
- The TA group will have significantly reduced weekly sum of standard drinks (SSD) and heavy drinking days (HDD) compared to MA at all time periods.
- TO will have significantly reduced SSD and HDD compared to MA at all time points.
- TA group will have significantly reduced SSD compared to TO at all time periods except one month follow-up.
- Severity will moderate the relationship between TA, MA and TO and drinking in that high severity P's will make significantly greater changes in the TA group.
Exploratory aims include testing other outcomes such as drinking related consequences by group, moderators such as gender and ethnicity, and mediators such as intervention relevance and self-efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drink Tracking (MA) Condition | Active comparator | Behavioral: Drink Tracking (MA)Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking. |
| TA Intervention | Experimental | Behavioral: Adaptive Tailored (TA)The TA intervention is tailored but will adapt over time too |
| Tailored Content Only (TO) | Experimental | Behavioral: Tailored (TO)The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be fluent and able to read in English at the eighth grade level;
- be between the ages of 21 and 75;
- have an estimated average weekly consumption of greater than 9 or 11 standard drinks per week for women and men, respectively OR at least two nights a week of drinking more than 4 drinks in one sitting for women and 5 drinks for men.
- be willing to reduce their drinking to non-hazardous levels;
- be willing to provide informed consent;
Key exclusion criteria (6 listed)
- present with significant substance use or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine), which is defined as greater than once weekly use in the past month/more than twice weekly use of marijuana;
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality;
- demonstrate clinically severe alcoholism, as evidenced by physical withdrawal symptoms or a history of serious withdrawal symptoms (e.g., hallucinations, seizures, or delirium tremens), and score greater than 12 on the Short Alcohol Withdrawal Scale (SAWS).
- report a medical condition that precludes drinking any alcohol; or
- demonstrate cognitive impairment as evidenced by a score of less than 7 out of 10 on the consent form quiz.
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 |
|---|---|---|
| Drink Tracking (MA)Weekly drink tracking for self-monitoring and assessment | Behavioural | Drink Tracking (MA) Condition |
| Adaptive Tailored (TA)Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress | Behavioural | TA Intervention |
| Tailored (TO)Messages are sent more frequently and tailored to some baseline characteristics | Behavioural | Tailored Content Only (TO) |
Primary outcome
Standard drinks
Time frame: 6 months
Weekly sum of standard drinks (SSD)
Heavy days
Time frame: 6 months
Heavy drinking days (HDD)
3 secondary outcomes
Weekly drinking
Time frame: 6 months
Daily drinking
Time frame: 6 months
Consequences
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink Tracking (MA), Adaptive Tailored (TA) and Tailored (TO) in people with Alcohol-Related Disorders and Alcohol Use Disorders, run by Partnership to End Addiction 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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. 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?
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?
Standard drinks (time frame: 6 months). The study lists 2 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 29 Jun 2021.