Tailored Mobile Text Messaging to Reduce Problem Drinking

Alcoholism Clinical Trial

Official title:

Tailored Mobile Text Messaging to Reduce Problem Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885312
• Other study ID #: AA021502-2
• Secondary ID: 1R34AA021502-01
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: October 12, 2016
• Start date: February 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorders
• Alcohol-Related Disorders
• Alcoholism
• Disease

Intervention

Behavioral:
• Adaptive Tailored Intervention
Adaptive
• Consequence-based Intervention
Loss Framed
• Tailored, not adaptive, based Intervention
Baseline tailored not adaptive

Other:
• Assessment only
EMA only

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research / North Shore-LIJ Health System	Great Neck	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Satisfaction		12 weeks	No
Primary	Days of Heavy Drinking (DHD)		12 weeks	No
Primary	Average Drinks per Week (ADW)		12 weeks	No
Secondary	Drinking Related Consequences		12 weeks	No
Secondary	Goal Commitment		12 weeks	No