Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

March 27, 2025 updated by: Silke Behrendt, University of Southern Denmark
High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Southern Denmark
      • Odense, Southern Denmark, Denmark, 5230
        • Recruiting
        • University of Southern Denmark, Department of Psychology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • consumption of > 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the Danish Health Authority) in the past four weeks
  • desire to reduce drinking
  • age 55 to 80 years
  • mobile phone ownership and willingness to receive and respond to text messages
  • fluency in Danish.

Exclusion Criteria:

  • drinking more than 53 standard drinks per week in the last four weeks
  • past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures)
  • score above 12 on the Short alcohol withdrawal scale; SAWS
  • possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month)
  • indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality)
  • current alcohol/drug abuse treatment or a desire to start alcohol/drug abuse treatment during the study
  • medical condition that requires abstinence from alcohol
  • wish to achieve abstinence (applied to secure a focus on reduction)
  • lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gain-framed
One daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less.
Behavioral: Text messaging
Participants receive text messages related to their alcohol consumption.
Experimental: Loss-framed
One daily text-message and weekly alcohol use assessment. The text-messages focus on the negative consequences of a high alcohol-intake.
Behavioral: Text messaging
Participants receive text messages related to their alcohol consumption.
Experimental: Static-tailored
One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking.
Behavioral: Text messaging
Participants receive text messages related to their alcohol consumption.
Experimental: Adaptive-tailored
One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking. In addition, text messages are adapted to the weekly alcohol-assessment over time and participants can demand supportive Just-In-Time messages.
Behavioral: Text messaging
Participants receive text messages related to their alcohol consumption.
Experimental: Combined
This arm combines all features of the arms Adaptive-tailored and Gain-framed.
Behavioral: Text messaging
Participants receive text messages related to their alcohol consumption.
No Intervention: Assessment-only
The control group. Participants do only receive 4 questions on their alcohol intake once a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High-risk alcohol use (yes/no)
Time Frame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Drinking over 120 gram ethanol in seven days (determined by outcomes 4 & 5 )
Assessed at 12 weeks after baseline, alcohol use through the past seven days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )
Time Frame: Assessed at 12 weeks after baseline
Quality of life, functioning. Higher scores represent higher quality of life.
Assessed at 12 weeks after baseline
OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)
Time Frame: Through the past seven days, assessed at 12 weeks after baseline
Degree of compulsive alcohol use, with higher scores representing a higher degree
Through the past seven days, assessed at 12 weeks after baseline
Drinker Inventory of Consequences (DrInC-2R)
Time Frame: Through the past 14 days, assessed at 12 weeks after baseline
Consequences of drinking, a higher score represents greater consequences
Through the past 14 days, assessed at 12 weeks after baseline
Frequency of alcohol use
Time Frame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Measured in number of days
Assessed at 12 weeks after baseline, alcohol use through the past seven days
Amount of alcohol use
Time Frame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Measured in standard drinks with one drink equivalent to 12 gram pure ethanol
Assessed at 12 weeks after baseline, alcohol use through the past seven days
Heavy drinking days
Time Frame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Count, number of days with 5 or more standard drinks
Assessed at 12 weeks after baseline, alcohol use through the past seven days
User evaluation (tailor-made)
Time Frame: Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)
Subjective evaluation of user-friendliness, quality of the messages, and cultural adaptation (participants rate the intervention on a scale from 0= do not agree at all through 6= fully agree). Participants also tick off boxes for simple questions on other help received in the study period and on their impressions of the language and cultural appropriateness.
Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)
PHQ-9 (Patient Health Questionnaire-9 )
Time Frame: Assessed at 12 weeks after baseline, through the past 14 days
A higher score represents a greater degree of depressive symptoms
Assessed at 12 weeks after baseline, through the past 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anette Søgaard Nielsen, PhD
Kjeld Andersen, PhD
Angelina Mellentin, PhD
Alexis Kuerbis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silke Behrendt, PhD, University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDU project nr. 3110386
  • ID: 158341 (Other Grant/Funding Number: Trygfonden)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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