Tailored Mobile Text Messaging to Reduce Problem Drinking

October 12, 2016 updated by: Northwell Health
This study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption; and test and compare it to tailored but static, once a day messaging, gain framed messaging, and ecological momentary assessment only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed development study entitled, Tailored Mobile Text Messaging to Reduce Problem Drinking is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption. This intervention includes messages tailored to baseline assessment results (including drinking times) that are adaptive to ongoing drinking patterns and goal achievement via interactive ecological momentary assessment (EMA). Other features include participant initiated help messaging and support network alerts. We will conduct beta research with 40 problem drinkers to assess messaging preferences and acceptability, and then conduct a pilot test with 10 PDs. In Stage 1b, we aim to test this intervention and understand the mechanisms of action of different text messaging interventions with 200 problem drinkers over a 12-week period. We propose to compare four types of messaging: 1) Tailored content and timed messaging adaptive to the participants current state (Stage 1a intervention); 2) Tailored content messaging (not adaptive or timed) sent at 3 pm every day; 3) Untailored consequence based messages sent at 3 pm every day; and 4) Brief feedback and EMA only. Assessments will be completed at baseline, through weekly EMA via SMS and at week 12 via a web-based follow-up assessment. Primary outcomes include drinks per drinking day, days of heavy drinking, and average drinks per week as measured through weekly EMA. Additional outcomes will include drinking related consequences, goal commitment and intervention satisfaction. Outcomes will be used to modify the intervention and to prepare for a larger Stage 1c RCT.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Great Neck, New York, United States, 11021
        • Feinstein Institute for Medical Research / North Shore-LIJ Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants must:

  • be fluent and able to read in English at the eighth grade level
  • be between the ages of 21 and 65
  • have an estimated average weekly consumption of greater than 15 or 24 standard drinks per week for women and men, respectively
  • be willing to reduce their drinking to non-hazardous levels
  • be willing to provide informed consent
  • own a mobile phone and have an active email address and are willing to receive and respond to up to 115 text messages total per month (average = 50)

Exclusion Criteria:

  • Participants will be excluded from the study if they
  • 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
  • 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)
  • express a desire or intent to obtain additional substance abuse treatment while in the study
  • report a medical condition that precludes drinking any alcohol; or
  • demonstrate cognitive impairment as evidenced a score of less than 7 out of 10 on the consent form quiz

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tailored not adaptive based Intervention
Tailored Text Messaging - not adaptive in the moment and once a day intervention to reduce problem drinking
Behavioral: Tailored, not adaptive, based Intervention
Baseline tailored not adaptive
Other: Ecological Momentary Assessment
Mobile Assessment only
Other: Assessment only
EMA only
Experimental: Tailored Adaptive Text Messaging
Tailored Adaptive Text Messaging intervention to reduce problem drinking
Behavioral: Adaptive Tailored Intervention
Adaptive
Active Comparator: Consequence based text messaging
Consequence based Text Messaging intervention to reduce problem drinking
Behavioral: Consequence-based Intervention
Loss Framed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days of Heavy Drinking (DHD)
Time Frame: 12 weeks
12 weeks
Average Drinks per Week (ADW)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Drinking Related Consequences
Time Frame: 12 weeks
12 weeks
Goal Commitment
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Intervention Satisfaction
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Fred Muench, PhD, Feinstein Institute for Medical Research / North Shore-LIJ Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA021502-2
  • 1R34AA021502-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Once cleaned and published will make available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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