Tailored Mobile Text Messaging to Reduce Problem Drinking

NCT ID: NCT01885312

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tailored not adaptive based Intervention

Tailored Text Messaging - not adaptive in the moment and once a day intervention to reduce problem drinking

Group Type ACTIVE_COMPARATOR

Tailored, not adaptive, based Intervention

Intervention Type BEHAVIORAL

Baseline tailored not adaptive

Ecological Momentary Assessment

Mobile Assessment only

Group Type OTHER

Assessment only

Intervention Type OTHER

EMA only

Tailored Adaptive Text Messaging

Tailored Adaptive Text Messaging intervention to reduce problem drinking

Group Type EXPERIMENTAL

Adaptive Tailored Intervention

Intervention Type BEHAVIORAL

Adaptive

Consequence based text messaging

Consequence based Text Messaging intervention to reduce problem drinking

Group Type ACTIVE_COMPARATOR

Consequence-based Intervention

Intervention Type BEHAVIORAL

Loss Framed

Interventions

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Adaptive Tailored Intervention

Adaptive

Intervention Type BEHAVIORAL

Consequence-based Intervention

Loss Framed

Intervention Type BEHAVIORAL

Tailored, not adaptive, based Intervention

Baseline tailored not adaptive

Intervention Type BEHAVIORAL

Assessment only

EMA only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Muench, PhD

Role: PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research / North Shore-LIJ Health System

Locations

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Feinstein Institute for Medical Research / North Shore-LIJ Health System

Great Neck, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1R34AA021502-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AA021502-2

Identifier Type: -

Identifier Source: org_study_id

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