NCT06126107

Brief Summary

The goal of this study is to evaluate effectiveness of scalable, tailored text- messaging programs for alcohol use among older adults. This study focuses on gain and loss framing of behavior change goals (i.e., the positives of change and the negatives of remaining with the status quo), critical components of behavioral science and health behavioral interventions. Loss-framing is used to motivate individuals to avoid future problems by focusing on the consequences of no change in behavior, and gain-framing is used to facilitate progress by focusing on the benefits of change. The investigators will design and evaluate three text-messaging programs using a randomized controlled trial: (A) Loss-framed messaging (B) Gain-framed messaging; and (C) Combined (loss and gain) messaging among a sample of 150 older adults with hazardous drinking. Participants will be randomized to one of the three conditions, each of which will include 8 weeks of text-messaging. During the study participants will completed assessments online and via text messages to track drinking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

November 1, 2023

Last Update Submit

March 10, 2025

Conditions

Keywords

Mobile HealthText messagingBehavioral economicsolder adults

Outcome Measures

Primary Outcomes (2)

  • Weekly sum of standard drinks

    Measure 1 of drinking, average of weekly sum of standard drinks

    baseline, week 4, week 8, and week 16

  • Weekly sum of heavy drinking days

    Measure 2 of drinking, average of weekly heavy drinking days

    baseline, week 4, week 8, and week 16

Secondary Outcomes (3)

  • Percent adherence to daily drinking assessment via text messages

    once daily, starting at baseline, lasting for 8 weeks

  • Percent adherence to weekly drinking assessment via web

    once weekly, starting at baseline, lasting 8 weeks

  • Percent willingness to continue the program for another 8 weeks

    At week 8 assessment

Study Arms (3)

Loss-framed Messaging

ACTIVE COMPARATOR

Daily text messages on the consequences of hazardous drinking (e.g., "Think of all you have lost as a result of drinking too much. Make today a day that sets the stage for change.")

Behavioral: Brief Normative FeedbackBehavioral: Loss-framed Text-messaging

Gain-framed Messaging

ACTIVE COMPARATOR

Daily text messages on the benefits of reducing drinking to safe guidelines (e.g., "Think of all you can achieve if you can control your drinking. Make today a day that sets the stage for change.")

Behavioral: Brief Normative FeedbackBehavioral: Gain-framed Text-messaging

Gain-framed and Loss-framed Messaging

ACTIVE COMPARATOR

Daily text messages that alternate between loss-framed (e.g., "Think of all you have lost as a result of drinking too much. Make today a day that sets the stage for change.") and gain-framed messaging (e.g., "Think of all you can achieve if you can control your drinking. Make today a day that sets the stage for change.")

Behavioral: Brief Normative FeedbackBehavioral: Loss-framed Text-messagingBehavioral: Gain-framed Text-messaging

Interventions

Once a participant has completed the assessment of their drinking during the baseline battery, the participant will receive brief normative feedback about how their drinking compares to their peers.

Gain-framed MessagingGain-framed and Loss-framed MessagingLoss-framed Messaging

Daily text-messages on the consequence of hazardous drinking.

Gain-framed and Loss-framed MessagingLoss-framed Messaging

Daily text messages on the benefits of reducing drinking to safe guidelines.

Gain-framed MessagingGain-framed and Loss-framed Messaging

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be fluent in and able to read English at the eighth grade level
  • Between the ages 50 and 85
  • Have an estimated average weekly consumption of greater than, for women and men 65 and older, 12, or for men 64 and younger, 15 standard drinks per week
  • Be willing to reduce their drinking to non-hazardous levels
  • Be willing to provide informed consent
  • Own a mobile phone with SMS capability and have an active email address.
  • Be willing to receive and respond to up to 120 text messages total per month, as well as four online, web- based surveys.

You may not qualify if:

  • Demonstrate physiological dependence on alcohol, as evidenced by current or a history of serious physical withdrawal symptoms (e.g., measured by SAWS)
  • Present with significant substance use (greater than weekly use) or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine, measured by self report on Form-90 based questions)
  • Present with a serious psychiatric illness or suicide risk, as measured by previous inpatient treatment, medications for mood disorder or psychosis, recent suicidality, and the PHQ-9.
  • Unable to understand research study procedures as evidenced by failing a short quiz at the end of reviewing the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College of CUNY

New York, New York, 10035, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Alexis Kuerbis, LCSW, PhD

    Silberman School of Social Work at Hunter College City, University of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blind to condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be urn randomized according to gender, age and intensity of drinking to the three conditions collected at screening. They will be assigned to one of 3 text-messaging programs.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 13, 2023

Study Start

February 26, 2024

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations