- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675812
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Stockholm County
-
Stockholm, Stockholm County, Sweden, 11761
- Alkoholhjälpen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hazardous alcohol use according to AUDIT-C (a score of 3 or more)
Exclusion Criteria:
- Ongoing care contact at a municipal or regional addiction clinic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active group
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.
|
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.
|
|
No Intervention: Referral to municipal care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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." |
Four weeks after recieving the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of available municipal support
Time Frame: Right after receiving the intervention.
|
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. |
Right after receiving the intervention.
|
|
Confidence in the help-seeking process
Time Frame: Four weeks after recieving the intervention
|
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. |
Four weeks after recieving the intervention
|
|
Concerns about negative consequences
Time Frame: Four weeks after recieving the intervention
|
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. |
Four weeks after recieving the intervention
|
|
Concerns about confidentiality
Time Frame: Four weeks after recieving the intervention
|
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. |
Four weeks after recieving the intervention
|
|
Impact of shame on help-seeking behavior
Time Frame: Four weeks after recieving the intervention
|
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. |
Four weeks after recieving the intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-04537-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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