Clinical trial NCT06319885: Text Messaging to Reduce High-risk Alcohol Use Among Older Adults
Official title: Text Messaging to Reduce High-risk Alcohol Use Among Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hazardous Alcohol Use
Keywords: older adults
digital intervention
prevention
text messaging
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Anette Søgaard Nielsen, PhD
name: Kjeld Andersen, PhD
name: Angelina Mellentin, PhD
name: Alexis Kuerbis
First posted: 2024-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: High-risk alcohol use (yes/no)
timeFrame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Secondary outcomes:
measure: WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )
timeFrame: Assessed at 12 weeks after baseline
measure: OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)
timeFrame: Through the past seven days, assessed at 12 weeks after baseline
measure: Drinker Inventory of Consequences (DrInC-2R)
timeFrame: Through the past 14 days, assessed at 12 weeks after baseline
measure: Frequency of alcohol use
timeFrame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
measure: Amount of alcohol use
timeFrame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
measure: Heavy drinking days
timeFrame: Assessed at 12 weeks after baseline, alcohol use through the past seven days
measure: User evaluation (tailor-made)
timeFrame: Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)
measure: PHQ-9 (Patient Health Questionnaire-9 )
timeFrame: Assessed at 12 weeks after baseline, through the past 14 days
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark, Department of Psychology
state: Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Silke Behrendt, PhD
role: PRINCIPAL_INVESTIGATOR
References: