Tailored Mobile Text Messaging to Reduce Problem Drinking

Sponsor

Northwell Health (Other)

Overall Status

Completed

CT.gov ID

NCT01885312

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

174

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Days of Heavy Drinking (DHD) [12 weeks]
Average Drinks per Week (ADW) [12 weeks]

Secondary Outcome Measures

Drinking Related Consequences [12 weeks]
Goal Commitment [12 weeks]

Other Outcome Measures

Intervention Satisfaction [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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