Messaging Interventions to Reduce Alcohol Problems Project (MIRAP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; Alcoholism; Alcohol-Related Disorders; Alcohol Use Disorders; Alcohol Abuse
• Intervention / Treatment: Behavioral: Drink Tracking (MA); Behavioral: Adaptive Tailored (TA); Behavioral: Tailored (TO)

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:

1. 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.
2. TO will have significantly reduced SSD and HDD compared to MA at all time points.
3. TA group will have significantly reduced SSD compared to TO at all time periods except one month follow-up.
4. 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 Type: Interventional
• Enrollment (Actual): 730
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Partnership for Drug-Free Kids

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. be fluent and able to read in English at the eighth grade level;
2. be between the ages of 21 and 75;
3. 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.
4. be willing to reduce their drinking to non-hazardous levels;
5. be willing to provide informed consent;
6. 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
7. give the name of a collateral who can be contacted in case of loss of contact or emergency.

Exclusion Criteria:

1. 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;
2. present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality;
3. 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).
4. report a medical condition that precludes drinking any alcohol; or
5. demonstrate cognitive impairment as evidenced by a score of less than 7 out of 10 on the consent form quiz.
6. express a desire to abstain or intent to obtain additional substance abuse treatment while in the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drink Tracking (MA) Condition; Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking.	Behavioral: Drink Tracking (MA); Weekly drink tracking for self-monitoring and assessment
Experimental: TA Intervention; The TA intervention is tailored but will adapt over time too	Behavioral: Adaptive Tailored (TA); Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress
Experimental: Tailored Content Only (TO); The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment.	Behavioral: Tailored (TO); Messages are sent more frequently and tailored to some baseline characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard drinks	Weekly sum of standard drinks (SSD)	6 months
Heavy days	Heavy drinking days (HDD)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly drinking	Drinking days per week	6 months
Daily drinking	Drinks per drinking day	6 months
Consequences	Drinking related consequences	6 months

Collaborators and Investigators

• Sponsor: Partnership to End Addiction
• Collaborators: Feinstein Institute for Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): February 18, 2021
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Mobile Phone; Technology; Drinking; Alcohol Problems; Reduced Drinking; Controlled Drinking; Text Message; Problem Drinking; Moderation-Oriented Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Disease; Alcohol-Related Disorders
• Other Study ID Numbers: 1R01AA025058 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No