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Messaging Interventions to Reduce Alcohol Problems Project (MIRAP)

Primary Purpose

Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drink Tracking (MA)
Adaptive Tailored (TA)
Tailored (TO)
Sponsored by
Partnership to End Addiction
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Drinking, Alcohol Problems, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Problem Drinking, Text Message, Mobile Phone, Technology

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Partnership for Drug-Free Kids

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Drink Tracking (MA) Condition

TA Intervention

Tailored Content Only (TO)

Arm Description

Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking.

The TA intervention is tailored but will adapt over time too

The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment.

Outcomes

Primary Outcome Measures

Standard drinks
Weekly sum of standard drinks (SSD)
Heavy days
Heavy drinking days (HDD)

Secondary Outcome Measures

Weekly drinking
Drinking days per week
Daily drinking
Drinks per drinking day
Consequences
Drinking related consequences

Full Information

First Posted
September 28, 2018
Last Updated
June 28, 2021
Sponsor
Partnership to End Addiction
Collaborators
Feinstein Institute for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT03695653
Brief Title
Messaging Interventions to Reduce Alcohol Problems Project
Acronym
MIRAP
Official Title
Tailored Adaptive Mobile Messaging to Reduce Problem Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Partnership to End Addiction
Collaborators
Feinstein Institute for Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
730 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drink Tracking (MA) Condition
Arm Type
Active Comparator
Arm Description
Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking.
Arm Title
TA Intervention
Arm Type
Experimental
Arm Description
The TA intervention is tailored but will adapt over time too
Arm Title
Tailored Content Only (TO)
Arm Type
Experimental
Arm Description
The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment.
Intervention Type
Behavioral
Intervention Name(s)
Drink Tracking (MA)
Intervention Description
Weekly drink tracking for self-monitoring and assessment
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Tailored (TA)
Intervention Description
Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress
Intervention Type
Behavioral
Intervention Name(s)
Tailored (TO)
Intervention Description
Messages are sent more frequently and tailored to some baseline characteristics
Primary Outcome Measure Information:
Title
Standard drinks
Description
Weekly sum of standard drinks (SSD)
Time Frame
6 months
Title
Heavy days
Description
Heavy drinking days (HDD)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weekly drinking
Description
Drinking days per week
Time Frame
6 months
Title
Daily drinking
Description
Drinks per drinking day
Time Frame
6 months
Title
Consequences
Description
Drinking related consequences
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Facility Information:
Facility Name
Partnership for Drug-Free Kids
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Messaging Interventions to Reduce Alcohol Problems Project

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