Hazardous Alcohol UseNCT06319885
Text Messaging to Reduce High-risk Alcohol Use Among Older Adults
A study testing Text messaging in people with Hazardous Alcohol Use, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hazardous Alcohol Use
- What is being tested?
- Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University of Southern Denmark, Department of Psychology
Odense, Southern Denmark, 5230
Silke Behrendt, PhD, sbehrendt@health.sdu.dk
About this study
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.
- Conditions
- Hazardous Alcohol Use
- Being tested
- Text messaging
- Keywords
- older adults, digital intervention, prevention, text messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingBehavioural
Participants receive text messages related to their alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Gain-framed | Experimental | One daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Text messaging |
| Combined | Experimental | This arm combines all features of the arms Adaptive-tailored and Gain-framed. Receives: Behavioral: Text messaging |
| Assessment-only | No intervention | The control group. Participants do only receive 4 questions on their alcohol intake once a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-risk alcohol use (yes/no)
Drinking over 120 gram ethanol in seven days (determined by outcomes 4 \& 5 )
Measured: 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 )
Quality of life, functioning. Higher scores represent higher quality of life.
Measured: Assessed at 12 weeks after baseline
OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)
Degree of compulsive alcohol use, with higher scores representing a higher degree
Measured: Through the past seven days, assessed at 12 weeks after baseline
Drinker Inventory of Consequences (DrInC-2R)
Consequences of drinking, a higher score represents greater consequences
Measured: Through the past 14 days, assessed at 12 weeks after baseline
Frequency of alcohol use
Measured in number of days
Measured: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Amount of alcohol use
Measured in standard drinks with one drink equivalent to 12 gram pure ethanol
Measured: Assessed at 12 weeks after baseline, alcohol use through the past seven days
Heavy drinking days
Count, number of days with 5 or more standard drinks
Measured: Assessed at 12 weeks after baseline, alcohol use through the past seven days
User evaluation (tailor-made)
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.
Measured: Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)
PHQ-9 (Patient Health Questionnaire-9 )
A higher score represents a greater degree of depressive symptoms
Measured: Assessed at 12 weeks after baseline, through the past 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Apr 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hazardous Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Anette Søgaard Nielsen, PhD, Kjeld Andersen, PhD, Angelina Mellentin, PhD, Alexis Kuerbis
- Responsible party
- Principal investigator, Silke Behrendt, University of Southern Denmark
- Investigators
- Silke Behrendt, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319885
- Sponsor's protocol ID
- SDU project nr. 3110386
- Other IDs
- ID: 158341
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Reduce High-risk Alcohol Use Among Older Adults
- ClinicalTrials.gov ID
- NCT06319885
- Acronym / sponsor ID
- SDU project nr. 3110386
- Conditions
- Hazardous Alcohol Use
- Keywords
- older adults, digital intervention, prevention, text messaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Anette Søgaard Nielsen, PhD, Kjeld Andersen, PhD, Angelina Mellentin, PhD, Alexis Kuerbis
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| Gain-framed | Experimental | Behavioral: Text messagingOne daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less. |
| Loss-framed | Experimental | Behavioral: Text messagingOne daily text-message and weekly alcohol use assessment. The text-messages focus on the negative consequences of a high alcohol-intake. |
| Static-tailored | Experimental | Behavioral: Text messagingOne 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. |
| Adaptive-tailored | Experimental | Behavioral: Text messagingOne 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. |
| Combined | Experimental | Behavioral: Text messagingThis arm combines all features of the arms Adaptive-tailored and Gain-framed. |
| Assessment-only | No intervention | –The control group. Participants do only receive 4 questions on their alcohol intake once a week. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messagingParticipants receive text messages related to their alcohol consumption. | Behavioural | Adaptive-tailored, Combined, Gain-framed, Loss-framed, Static-tailored |
Primary outcome
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 )
8 secondary outcomes
WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )
Time frame: Assessed at 12 weeks after baseline
OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)
Time frame: 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
Frequency of alcohol use
Time frame: 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
Heavy drinking days
Time frame: 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)
PHQ-9 (Patient Health Questionnaire-9 )
Time frame: Assessed at 12 weeks after baseline, through the past 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silke Behrendt, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging in people with Hazardous Alcohol Use, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silke Behrendt, PhD (+4593507195, sbehrendt@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-risk alcohol use (yes/no) (time frame: Assessed at 12 weeks after baseline, alcohol use through the past seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.