Clinical trial NCT06126107: Gain and Loss Framed Text Messaging to Reduce Drinking Among Older Adults
Official title: Gain and Loss Framed Text Messaging to Reduce Drinking Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: Mobile Health
Text messaging
Behavioral economics
older adults
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 133
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Weekly sum of standard drinks
timeFrame: baseline, week 4, week 8, and week 16
measure: Weekly sum of heavy drinking days
timeFrame: baseline, week 4, week 8, and week 16
Secondary outcomes:
measure: Percent adherence to daily drinking assessment via text messages
timeFrame: once daily, starting at baseline, lasting for 8 weeks
measure: Percent adherence to weekly drinking assessment via web
timeFrame: once weekly, starting at baseline, lasting 8 weeks
measure: Percent willingness to continue the program for another 8 weeks
timeFrame: At week 8 assessment
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College of CUNY
state: New York
Study officials:
affiliation: Silberman School of Social Work at Hunter College City, University of New York
name: Alexis Kuerbis, LCSW, PhD
role: PRINCIPAL_INVESTIGATOR
References: