Alcohol AbuseNCT06675812
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
A study testing Information intervention in people with Alcohol Abuse and Harmful Alcohol Use, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Many people who have risky alcohol use or alcohol dependence do not seek help, often is due to concerns about potential consequences or feelings of shame. At the same time, the prognosis is good for those who do seek help and there are effective treatments available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Harmful Alcohol Use, Hazardous Alcohol Use
- What is being tested?
- Information intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 18 Nov 2024to 31 Jan 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hazardous alcohol use according to AUDIT-C (a score of 3 or more)
Who cannot join
- Ongoing care contact at a municipal or regional addiction clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Many people who have risky alcohol use or alcohol dependence do not seek help, often is due to concerns about potential consequences or feelings of shame. At the same time, the prognosis is good for those who do seek help and there are effective treatments available.
This project aims to investigate whether increased information about the process can lower these barriers, and in turn encourage more people to seek help for alcohol-related problems.
Read the detailed description
In Sweden, 4% suffer from alcohol dependency, and up to one-third of all adults have risky consumption of alcohol. This does not only cause suffering for the individual with the problem, but also for their relatives as well as contribute to significant costs for the Swedish society. Moreover, only a small proportion of those with problematic use or dependence of alcohol actually seek-, and receive help. This can be explained by both internal factors, such as feelings of shame and the belief that "one should be able to overcome dependence on their own," as well as external factors like low availability of appealing interventions.
The addiction care in Sweden is unique in that it is a shared responsibility between the regional health care system and the municipalities' social services. The distribution of responsibilities varies significantly across different parts of Sweden, which means that the interventions available to individuals seeking help vary depending on where they live. Previous research has shown that only about 5% of people with alcohol problems wish to seek help through social services, which suggests that in parts of Sweden where social services are the primary treatment option, fewer people may receive help for their issues.
Also, in a previous study that investigated barriers to seek help at social service, fear of consequences and having the problems documented, was identified as one of the largest barriers, with a suggestion that more transparency on how the social service works would reduce this.
Therefore, this study aims to investigate whether more people with problematic alcohol use and alcohol dependency can be encouraged to seek help from social services if they first receive a micro-intervention addressing common barriers to seeking help from social services. The intervention will be based on results from the study mentioned above, targeting the barriers revealed in the results.
The research project will be integrated as an intervention on the already existing website alcoholhjälpen.se, a site and forum run by Region Stockholm that is directed at people with alcohol problems and their relatives throughout Sweden. All users on alcoholhjälpen are anonymous. A new feature will be introduced here: "What help is available locally for me?", which will serve as the entry point to the study. Pre-measurements, consent, phone numbers and email addresses, and the participant's municipality will be collected, as well as asking the participant what is preventing him or her to seek help today. Then the participant will be randomized into either the intervention or control group. The intervention group will receive the micro-intervention, with both information about what is offered in his or her municipality, as well as information about the barriers that the participant has stated. For instance, if the participant has written that fear of losing custody of his or her child, information about how the process goes, and what rights one has as a parent etc will be presented. The control group will receive a referral to their municipality, saying that this is where they seek help. One month later, follow-ups will be conducted to measure the likelihood that the participant will seek help from social services, which is the primary outcome measure.
- Conditions
- Alcohol Abuse, Harmful Alcohol Use, Hazardous Alcohol Use, Hazardous Drinking, Risky Drinking
- Being tested
- Information intervention
- Keywords
- Help-seeking, Treatment gap, Referral to treatment, Social services, Information intervention, Alcohol, Drinking
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information interventionOther
The participant will receive information on what treatment that is offered in their municipal, how the help-seeking process goes (where they can be anonymous etc), and tailored information regarding the barriers that the participant has stated preventing him or her for seeking help today.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The participant will receive information on what treatment that is offered in their municipal, how the help-seeking process goes (where they can be anonymous etc), and tailored information regarding the barriers that the participant has stated preventing him or her for seeking help today. Receives: Other: Information intervention |
| Referral to municipal care | No intervention | At the anonymous help service where the intervention will be used, is standard practice to refer the person to the municipal care, if he or she request for more help. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of seeking help
This will be formulated approximately like this: "How likely are you to seek help for your alcohol use from the municipality?"
And the response would be on a VAS scale, where 1 is "Very unlikely" and 10 is "Very likely/already have."
Measured: Four weeks after recieving the intervention
Secondary outcomes (5)
Knowledge of available municipal support
Assessed by participants' self-reported awareness of the help they can receive from their municipality.
This will be formulated approximately like this: "How well do you know what kind of help you can receive from your municipality?"
And the response would be on a VAS scale from 1-10.
Measured: Right after receiving the intervention.
Confidence in the help-seeking process
Measured by participants' self-reported confidence in how the process works when seeking help from the municipality.
This will be formulated approximately like this: "How confident do you feel about the process if you seek help from the municipality?"
And the response would be on a VAS scale from 1-10.
Measured: Four weeks after recieving the intervention
Concerns about negative consequences
Evaluated through participants self-reported worry about potential negative outcomes from seeking help.
This will be formulated approximately like this: "How worried are you about negative consequences if you seek help from the municipality?"
And the response would be on a VAS scale from 1-10.
Measured: Four weeks after recieving the intervention
Concerns about confidentiality
Assessed by participants self-reported concerns about maintaining privacy when seeking help.
This will be formulated approximately like this: "How concerned are you about privacy or that someone you don't want to know might find out if you seek help from the municipality?"
And the response would be on a VAS scale from 1-10.
Measured: Four weeks after recieving the intervention
Impact of shame on help-seeking behavior
Measured by how much self-reported shame or embarrassment participants reports preventing them from seeking help
This will be formulated approximately like this: "How much does shame or feeling embarrassed prevent you from seeking help?"
And the response would be on a VAS scale from 1-10.
Measured: Four weeks after recieving the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start18 Nov 2024
- Primary completion2 Dec 2025
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm Center for Dependency Disorders
- Responsible party
- Principal investigator, Magnus Johansson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675812
- Sponsor's protocol ID
- 2023-04537-01
- Other IDs
- 2023
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
- ClinicalTrials.gov ID
- NCT06675812
- Acronym / sponsor ID
- 2023-04537-01
- Conditions
- Alcohol Abuse, Harmful Alcohol Use, Hazardous Alcohol Use, Hazardous Drinking, Risky Drinking
- Keywords
- Help-seeking, Treatment gap, Referral to treatment, Social services, Information intervention, Alcohol, Drinking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm Center for Dependency Disorders
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Nov 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.
Many people who have risky alcohol use or alcohol dependence do not seek help, often is due to concerns about potential consequences or feelings of shame. At the same time, the prognosis is good for those who do seek help and there are effective treatments available.
This project aims to investigate whether increased information about the process can lower these barriers, and in turn encourage more people to seek help for alcohol-related problems.
Detailed description
In Sweden, 4% suffer from alcohol dependency, and up to one-third of all adults have risky consumption of alcohol. This does not only cause suffering for the individual with the problem, but also for their relatives as well as contribute to significant costs for the Swedish society. Moreover, only a small proportion of those with problematic use or dependence of alcohol actually seek-, and receive help. This can be explained by both internal factors, such as feelings of shame and the belief that "one should be able to overcome dependence on their own," as well as external factors like low availability of appealing interventions.
The addiction care in Sweden is unique in that it is a shared responsibility between the regional health care system and the municipalities' social services. The distribution of responsibilities varies significantly across different parts of Sweden, which means that the interventions available to individuals seeking help vary depending on where they live. Previous research has shown that only about 5% of people with alcohol problems wish to seek help through social services, which suggests that in parts of Sweden where social services are the primary treatment option, fewer people may receive help for their issues.
Also, in a previous study that investigated barriers to seek help at social service, fear of consequences and having the problems documented, was identified as one of the largest barriers, with a suggestion that more transparency on how the social service works would reduce this.
Therefore, this study aims to investigate whether more people with problematic alcohol use and alcohol dependency can be encouraged to seek help from social services if they first receive a micro-intervention addressing common barriers to seeking help from social services. The intervention will be based on results from the study mentioned above, targeting the barriers revealed in the results.
The research project will be integrated as an intervention on the already existing website alcoholhjälpen.se, a site and forum run by Region Stockholm that is directed at people with alcohol problems and their relatives throughout Sweden. All users on alcoholhjälpen are anonymous. A new feature will be introduced here: "What help is available locally for me?", which will serve as the entry point to the study. Pre-measurements, consent, phone numbers and email addresses, and the participant's municipality will be collected, as well as asking the participant what is preventing him or her to seek help today. Then the participant will be randomized into either the intervention or control group. The intervention group will receive the micro-intervention, with both information about what is offered in his or her municipality, as well as information about the barriers that the participant has stated. For instance, if the participant has written that fear of losing custody of his or her child, information about how the process goes, and what rights one has as a parent etc will be presented. The control group will receive a referral to their municipality, saying that this is where they seek help. One month later, follow-ups will be conducted to measure the likelihood that the participant will seek help from social services, which is the primary outcome measure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Other: Information interventionThe participant will receive information on what treatment that is offered in their municipal, how the help-seeking process goes (where they can be anonymous etc), and tailored information regarding the barriers that the participant has stated preventing him or her for seeking help today. |
| Referral to municipal care | No intervention | –At the anonymous help service where the intervention will be used, is standard practice to refer the person to the municipal care, if he or she request for more help. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hazardous alcohol use according to AUDIT-C (a score of 3 or more)
Key exclusion criteria (1 listed)
- Ongoing care contact at a municipal or regional addiction clinic.
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 |
|---|---|---|
| Information interventionThe participant will receive information on what treatment that is offered in their municipal, how the help-seeking process goes (where they can be anonymous etc), and tailored information regarding the barriers that the participant has stated preventing him or her for seeking help today. | Other | Active group |
Primary outcome
Likelihood of seeking help
Time frame: Four weeks after recieving the intervention
This will be formulated approximately like this: "How likely are you to seek help for your alcohol use from the municipality?" And the response would be on a VAS scale, where 1 is "Very unlikely" and 10 is "Very likely/already have."
5 secondary outcomes
Knowledge of available municipal support
Time frame: Right after receiving the intervention.
Confidence in the help-seeking process
Time frame: Four weeks after recieving the intervention
Concerns about negative consequences
Time frame: Four weeks after recieving the intervention
Concerns about confidentiality
Time frame: Four weeks after recieving the intervention
Impact of shame on help-seeking behavior
Time frame: Four weeks after recieving the intervention
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information intervention in people with Alcohol Abuse and Harmful Alcohol Use, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood of seeking help (time frame: Four weeks after recieving the intervention). 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 15 Sep 2026.