NCT01885312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

June 20, 2013

Last Update Submit

October 12, 2016

Conditions

Alcohol-Related DisordersAlcohol Use DisordersAlcohol DrinkingAlcoholismAlcohol Abuse

Keywords

DrinkingHeavy DrinkingTechnologyMobile PhoneText MessageProblem DrinkingAlcohol ProblemsAlcoholismModeration-Oriented TreatmentControlled DrinkingReduced Drinking

Outcome Measures

Primary Outcomes (2)

  • Days of Heavy Drinking (DHD)

    12 weeks

  • Average Drinks per Week (ADW)

    12 weeks

Secondary Outcomes (2)

  • Drinking Related Consequences

    12 weeks

  • Goal Commitment

    12 weeks

Other Outcomes (1)

  • Intervention Satisfaction

    12 weeks

Study Arms (4)

Tailored not adaptive based Intervention

ACTIVE COMPARATOR

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

Behavioral: Tailored, not adaptive, based Intervention

Ecological Momentary Assessment

OTHER

Mobile Assessment only

Other: Assessment only

Tailored Adaptive Text Messaging

EXPERIMENTAL

Tailored Adaptive Text Messaging intervention to reduce problem drinking

Behavioral: Adaptive Tailored Intervention

Consequence based text messaging

ACTIVE COMPARATOR

Consequence based Text Messaging intervention to reduce problem drinking

Behavioral: Consequence-based Intervention

Interventions

Adaptive Tailored InterventionBEHAVIORAL

Adaptive

Tailored Adaptive Text Messaging
Consequence-based InterventionBEHAVIORAL

Loss Framed

Consequence based text messaging
Tailored, not adaptive, based InterventionBEHAVIORAL

Baseline tailored not adaptive

Tailored not adaptive based Intervention
Assessment onlyOTHER

EMA only

Ecological Momentary Assessment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersAlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Officials

  • Fred Muench, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 24, 2013

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)