NCT06319885

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 4, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 4, 2024

Last Update Submit

March 27, 2025

Conditions

Keywords

older adultsdigital interventionpreventiontext messaging

Outcome Measures

Primary Outcomes (1)

  • High-risk alcohol use (yes/no)

    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 Outcomes (8)

  • WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )

    Assessed at 12 weeks after baseline

  • OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)

    Through the past seven days, assessed at 12 weeks after baseline

  • Drinker Inventory of Consequences (DrInC-2R)

    Through the past 14 days, assessed at 12 weeks after baseline

  • Frequency of alcohol use

    Assessed at 12 weeks after baseline, alcohol use through the past seven days

  • Amount of alcohol use

    Assessed at 12 weeks after baseline, alcohol use through the past seven days

  • +3 more secondary outcomes

Study Arms (6)

Gain-framed

EXPERIMENTAL

One daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less.

Behavioral: Text messaging

Loss-framed

EXPERIMENTAL

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

Static-tailored

EXPERIMENTAL

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

Adaptive-tailored

EXPERIMENTAL

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

Combined

EXPERIMENTAL

This arm combines all features of the arms Adaptive-tailored and Gain-framed.

Behavioral: Text messaging

Assessment-only

NO INTERVENTION

The control group. Participants do only receive 4 questions on their alcohol intake once a week.

Interventions

Text messagingBEHAVIORAL

Participants receive text messages related to their alcohol consumption.

Adaptive-tailoredCombinedGain-framedLoss-framedStatic-tailored

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark, Department of Psychology

Odense, Southern Denmark, 5230, Denmark

RECRUITING

Study Officials

  • Silke Behrendt, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silke Behrendt, PhD

CONTACT

Anette S Nielsen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 20, 2024

Study Start

April 15, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations