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Tailored Mobile Text Messaging to Reduce Problem Drinking

Primary Purpose

Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adaptive Tailored Intervention

Consequence-based Intervention

Tailored, not adaptive, based Intervention

Assessment only

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Drinking, Heavy Drinking, Technology, Mobile Phone, Text Message, Problem Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Experimental

Active Comparator

Arm Label

Tailored not adaptive based Intervention

Ecological Momentary Assessment

Tailored Adaptive Text Messaging

Consequence based text messaging

Arm Description

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

Mobile Assessment only

Tailored Adaptive Text Messaging intervention to reduce problem drinking

Consequence based Text Messaging intervention to reduce problem drinking

Outcomes

Primary Outcome Measures

Days of Heavy Drinking (DHD)

Average Drinks per Week (ADW)

Secondary Outcome Measures

Drinking Related Consequences

Goal Commitment

Full Information

NCT ID

NCT01885312

First Posted

June 20, 2013

Last Updated

October 12, 2016

Sponsor

Northwell Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT01885312

Brief Title

Tailored Mobile Text Messaging to Reduce Problem Drinking

Official Title

Tailored Mobile Text Messaging to Reduce Problem Drinking

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tailored not adaptive based Intervention

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ecological Momentary Assessment

Arm Type

Other

Arm Description

Mobile Assessment only

Arm Title

Tailored Adaptive Text Messaging

Arm Type

Experimental

Arm Description

Tailored Adaptive Text Messaging intervention to reduce problem drinking

Arm Title

Consequence based text messaging

Arm Type

Active Comparator

Arm Description

Consequence based Text Messaging intervention to reduce problem drinking

Intervention Type

Behavioral

Intervention Name(s)

Adaptive Tailored Intervention

Intervention Description

Adaptive

Intervention Type

Behavioral

Intervention Name(s)

Consequence-based Intervention

Intervention Description

Loss Framed

Intervention Type

Behavioral

Intervention Name(s)

Tailored, not adaptive, based Intervention

Intervention Description

Baseline tailored not adaptive

Intervention Type

Other

Intervention Name(s)

Assessment only

Intervention Description

EMA only

Primary Outcome Measure Information:

Title

Days of Heavy Drinking (DHD)

Time Frame

12 weeks

Title

Average Drinks per Week (ADW)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Drinking Related Consequences

Time Frame

12 weeks

Title

Goal Commitment

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Intervention Satisfaction

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Muench, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Once cleaned and published will make available

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