Clinical trial NCT01885312: Tailored Mobile Text Messaging to Reduce Problem Drinking
Official title: Tailored Mobile Text Messaging to Reduce Problem Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Related Disorders
Alcohol Use Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse
Keywords: Drinking
Heavy Drinking
Technology
Mobile Phone
Text Message
Problem Drinking
Alcohol Problems
Alcoholism
Moderation-Oriented Treatment
Controlled Drinking
Reduced Drinking
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2013-06-24
Enrollment: 174
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Days of Heavy Drinking (DHD)
timeFrame: 12 weeks
measure: Average Drinks per Week (ADW)
timeFrame: 12 weeks
Secondary outcomes:
measure: Drinking Related Consequences
timeFrame: 12 weeks
measure: Goal Commitment
timeFrame: 12 weeks
Other outcomes:
measure: Intervention Satisfaction
timeFrame: 12 weeks
Locations:
city: Great Neck
country: United States
facility: Feinstein Institute for Medical Research / North Shore-LIJ Health System
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research / North Shore-LIJ Health System
name: Fred Muench, PhD
role: PRINCIPAL_INVESTIGATOR
References: