NCT03695653

Brief Summary

The study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption. According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence. Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
730

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 24, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 29, 2021

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

September 28, 2018

Last Update Submit

June 28, 2021

Conditions

Keywords

DrinkingAlcohol ProblemsModeration-Oriented TreatmentControlled DrinkingReduced DrinkingProblem DrinkingText MessageMobile PhoneTechnology

Outcome Measures

Primary Outcomes (2)

  • Standard drinks

    Weekly sum of standard drinks (SSD)

    6 months

  • Heavy days

    Heavy drinking days (HDD)

    6 months

Secondary Outcomes (3)

  • Weekly drinking

    6 months

  • Daily drinking

    6 months

  • Consequences

    6 months

Study Arms (3)

Drink Tracking (MA) Condition

ACTIVE COMPARATOR

Ps will receive weekly mobile assessment trick tracking described above for six months in addition to the guidelines on safe drinking.

Behavioral: Drink Tracking (MA)

TA Intervention

EXPERIMENTAL

The TA intervention is tailored but will adapt over time too

Behavioral: Adaptive Tailored (TA)

Tailored Content Only (TO)

EXPERIMENTAL

The TO treatment arm includes tailored text messages sent at 6pm daily based on the baseline assessment.

Behavioral: Tailored (TO)

Interventions

Weekly drink tracking for self-monitoring and assessment

Drink Tracking (MA) Condition

Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress

TA Intervention
Tailored (TO)BEHAVIORAL

Messages are sent more frequently and tailored to some baseline characteristics

Tailored Content Only (TO)

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be fluent and able to read in English at the eighth grade level;
  • be between the ages of 21 and 75;
  • have an estimated average weekly consumption of greater than 9 or 11 standard drinks per week for women and men, respectively OR at least two nights a week of drinking more than 4 drinks in one sitting for women and 5 drinks for men.
  • be willing to reduce their drinking to non-hazardous levels;
  • be willing to provide informed consent;
  • own a mobile phone, have an active email address, are willing to receive and respond to up to 115 text messages total per month (average = 50); and
  • give the name of a collateral who can be contacted in case of loss of contact or emergency.

You may not qualify if:

  • 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/more than twice weekly use of marijuana;
  • 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).
  • report a medical condition that precludes drinking any alcohol; or
  • demonstrate cognitive impairment as evidenced by a score of less than 7 out of 10 on the consent form quiz.
  • express a desire to abstain or intent to obtain additional substance abuse treatment while in the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partnership for Drug-Free Kids

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersAlcoholismAlcohol Drinking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

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

September 28, 2018

First Posted

October 4, 2018

Study Start

May 24, 2019

Primary Completion

February 18, 2021

Study Completion

November 1, 2023

Last Updated

June 29, 2021

Record last verified: 2020-07

Locations