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Tailored Mobile Text Messaging to Reduce Problem Drinking

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ClinicalTrials.gov Identifier: NCT01885312
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol-Related Disorders Alcohol Use Disorders Alcohol Drinking Alcoholism Alcohol Abuse Behavioral: Adaptive Tailored Intervention Behavioral: Consequence-based Intervention Behavioral: Tailored, not adaptive, based Intervention Other: Assessment only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Mobile Text Messaging to Reduce Problem Drinking
Study Start Date : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Days of Heavy Drinking (DHD) [ Time Frame: 12 weeks ]
  2. Average Drinks per Week (ADW) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Drinking Related Consequences [ Time Frame: 12 weeks ]
  2. Goal Commitment [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Intervention Satisfaction [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885312


Locations
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United States, New York
Feinstein Institute for Medical Research / North Shore-LIJ Health System
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Northwell Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Fred Muench, PhD Feinstein Institute for Medical Research / North Shore-LIJ Health System

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01885312     History of Changes
Other Study ID Numbers: AA021502-2
1R34AA021502-01 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once cleaned and published will make available

Keywords provided by Northwell Health:
Drinking
Heavy Drinking
Technology
Mobile Phone
Text Message
Problem Drinking
Alcohol Problems
Alcoholism
Moderation-Oriented Treatment
Controlled Drinking
Reduced Drinking

Additional relevant MeSH terms:
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Disease
Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior