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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06126107
Other study ID # 2023-0653-Hunter
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 26, 2024
Est. completion date September 1, 2024

Study information

Verified date March 2024
Source Hunter College of City University of New York
Contact Alexis Kuerbis, LCSW, PhD
Phone 9173017903
Email ak1465@hunter.cuny.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

There is an urgent call for efficient and effective assessment, prevention, and intervention among older adults (age 50 and older) to reduce health risk of hazardous drinking, encourage healthy aging, and reduce burden on healthcare systems. Brief, low-burden, low-cost, digital interventions among older adults can answer this call. Text-messaging health interventions are considered an effective, scalable way to deliver behavioral health interventions, and they have been used as evidence-based solutions in primary care settings among older adults for behaviors other than alcohol use to supplement traditional care. Contrary to stereotypes, older adults use mobile technology, seek online and mobile interventions, and often engage longer compared to younger populations. The primary objective of the proposed 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 last 8 weeks. Participants will undergo cross- sectional online assessments (baseline, week 4, week 8 and week 16), and they will also complete a mobile assessment (via text message) once per week to track drinking. The effects of condition on drinking behavior will be compared at weeks 4, 8 and 16. In addition, attrition from the study will be closely tracked. Finally, the investigators will explore how the effects condition are impacted by gender and age (via moderation analysis).


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Normative Feedback
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.
Loss-framed Text-messaging
Daily text-messages on the consequence of hazardous drinking.
Gain-framed Text-messaging
Daily text messages on the benefits of reducing drinking to safe guidelines.

Locations

Country Name City State
United States Hunter College of CUNY New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hunter College of City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weekly sum of standard drinks Measure 1 of drinking, average of weekly sum of standard drinks baseline, week 4, week 8, and week 16
Primary 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 Percent adherence to daily drinking assessment via text messages Responses to text messages (via text message) are considered "adherence" to the daily drinking assessment. This measure is akin to compliance. once daily, starting at baseline, lasting for 8 weeks
Secondary Percent adherence to weekly drinking assessment via web Responses to text messages (via text message) are considered "adherence" to the weekly drinking assessment. This measure is akin to compliance. once weekly, starting at baseline, lasting 8 weeks
Secondary Percent willingness to continue the program for another 8 weeks Participants are asked, "would you like to continue to receive text messages for the next 8 weeks?" If participants report yes, that is willingness to continue in the program. If no, then participants are not willing to continue in the program. At week 8 assessment
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