Excessive DrinkingNCT05321238
The Role of Agency and Threat-Immediacy in Interactive Digital Narrative Fear Appeals
A study testing High agency and immediate threat, High agency and distant threat and Low agency and immediate threat in people with Excessive Drinking, run by Tilburg University at 1 site in Netherlands.
Trial summary
Aims: The first aim of the study was to assess the effect of agency, i.e. the perception of making meaningful decisions, in an interactive digital narrative fear appeal on self-efficacy beliefs concerning the ability to reduce alcohol intake among college students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Excessive Drinking
- What is being tested?
- High agency and immediate threat, High agency and distant threat and Low agency and immediate threat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- above 18 years of age
- 480 seconds survey completion time
- both attention checks relating to narrative content passed
- correctly identified their experimental condition in the manipulation check
- did not choose to 'drink an alcoholic drink' for all decisions in the interactive narrative
- did not show signs of alcohol abuse
Who cannot join
- under the age of 18
- completed the questionnaire in an unreasonably short amount of time
- they failed one of the two attention checks
- failed the manipulation check asking them to recall whether they were presented with short- or long-term (high / low immediacy) consequences of excessive drinking
- chose an alcoholic drink for all decision points
- showed signs of alcohol dependence as measured above 15 on the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Agency and Threat-Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial
Aims:
The first aim of the study was to assess the effect of agency, i.e. the perception of making meaningful decisions, in an interactive digital narrative fear appeal on self-efficacy beliefs concerning the ability to reduce alcohol intake among college students. Second, we assessed whether the communicated timeframe (short-term / long-term) of the threat presented in the narrative moderates the effect of agency on self-efficacy. Lastly, to validate the effect of the intervention on behavioural outcomes we assesed whether self-efficacy has an effect on behavioural intention measures.
The study was a 2 (agency: low / high) x 2 (time-frame: immediate / distant) between-subjects online experiment.
- Conditions
- Excessive Drinking
- Being tested
- High agency and immediate threat, High agency and distant threat, Low agency and immediate threat, Low agency and distant threat
- Keywords
- agency, fear appeal, alcohol, narrative
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High agency and immediate threatOther
Participants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time.
High agency and distant threatOther
Participants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time.
Low agency and immediate threatOther
Participants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time.
Low agency and distant threatOther
Participants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time.
| Study group | Role | What they receive |
|---|---|---|
| High agency and immediate threat | Experimental | Participants were asked to make decisions within the interactive digital narrative and were presented with acute alcohol poisoning of the main character in the story. Receives: Other: High agency and immediate threat |
| High agency and distant threat | Experimental | Participants were asked to make decisions within the interactive digital narrative and were presented with multiple organ failure after years of alcohol consumption of the main character in the story. Receives: Other: High agency and distant threat |
| Low agency and immediate threat | Experimental | Participants were presented with a fixed (passive) narrative without decisions and were presented with acute alcohol poisoning of the main character in the story. Receives: Other: Low agency and immediate threat |
| Low agency and distant threat | Experimental | Participants were presented with a fixed (passive) narrative without decisions and were presented with multiple organ failure after years of alcohol consumption of the main character in the story. Receives: Other: Low agency and distant threat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived self-efficacy
Three items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'):
- I am able to limit my alcohol intake to low amounts.
- It is easy for me to limit my alcohol intake to low amounts.
- I can limit my alcohol intake to low amounts.
Measured: During the lab session
Behavioural intention
Four items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'):
- I intend to limit my alcohol intake to low amounts.
- I intend to limit my alcohol intake to low amounts on special occasions.
- I intend to limit my alcohol intake to low amounts when being with friends.
- I intend to limit my alcohol intake to low amounts when I am by myself.
Measured: During the lab session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 Nov 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive DrinkingStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendrik Engelbrecht, Tilburg University
- Investigators
- Hendrik Engelbrecht, Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321238
- Sponsor's protocol ID
- 2020.141
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Engelbrecht H, van der Laan LN, van Enschot R, Krahmer E. The Role of Agency and Threat Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e32218. doi: 10.2196/32218.
PubMed 35699976
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Agency and Threat-Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05321238
- Acronym / sponsor ID
- 2020.141
- Conditions
- Excessive Drinking
- Keywords
- agency, fear appeal, alcohol, narrative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 11 Apr 2022 (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.
Aims:
The first aim of the study was to assess the effect of agency, i.e. the perception of making meaningful decisions, in an interactive digital narrative fear appeal on self-efficacy beliefs concerning the ability to reduce alcohol intake among college students. Second, we assessed whether the communicated timeframe (short-term / long-term) of the threat presented in the narrative moderates the effect of agency on self-efficacy. Lastly, to validate the effect of the intervention on behavioural outcomes we assesed whether self-efficacy has an effect on behavioural intention measures.
The study was a 2 (agency: low / high) x 2 (time-frame: immediate / distant) between-subjects online experiment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High agency and immediate threat | Experimental | Other: High agency and immediate threatParticipants were asked to make decisions within the interactive digital narrative and were presented with acute alcohol poisoning of the main character in the story. |
| High agency and distant threat | Experimental | Other: High agency and distant threatParticipants were asked to make decisions within the interactive digital narrative and were presented with multiple organ failure after years of alcohol consumption of the main character in the story. |
| Low agency and immediate threat | Experimental | Other: Low agency and immediate threatParticipants were presented with a fixed (passive) narrative without decisions and were presented with acute alcohol poisoning of the main character in the story. |
| Low agency and distant threat | Experimental | Other: Low agency and distant threatParticipants were presented with a fixed (passive) narrative without decisions and were presented with multiple organ failure after years of alcohol consumption of the main character in the story. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- above 18 years of age
- 480 seconds survey completion time
- both attention checks relating to narrative content passed
- correctly identified their experimental condition in the manipulation check
- did not choose to 'drink an alcoholic drink' for all decisions in the interactive narrative
Key exclusion criteria (6 listed)
- under the age of 18
- completed the questionnaire in an unreasonably short amount of time
- they failed one of the two attention checks
- failed the manipulation check asking them to recall whether they were presented with short- or long-term (high / low immediacy) consequences of excessive drinking
- chose an alcoholic drink for all decision points
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 |
|---|---|---|
| High agency and immediate threatParticipants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time. | Other | High agency and immediate threat |
| High agency and distant threatParticipants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time. | Other | High agency and distant threat |
| Low agency and immediate threatParticipants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time. | Other | Low agency and immediate threat |
| Low agency and distant threatParticipants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time. | Other | Low agency and distant threat |
Primary outcome
Perceived self-efficacy
Time frame: During the lab session
Three items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'): 1. I am able to limit my alcohol intake to low amounts. 2. It is easy for me to limit my alcohol intake to low amounts. 3. I can limit my alcohol intake to low amounts.
Behavioural intention
Time frame: During the lab session
Four items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'): 1. I intend to limit my alcohol intake to low amounts. 2. I intend to limit my alcohol intake to low amounts on special occasions. 3. I intend to limit my alcohol intake to low amounts when being with friends. 4. I intend to limit my alcohol intake to low amounts when I am by myself.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 35699976Engelbrecht H, van der Laan LN, van Enschot R, Krahmer E. The Role of Agency and Threat Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e32218. doi: 10.2196/32218.
- Individual participant dataSharing planned: No
Related trials for Excessive Drinking
Active, not recruiting
Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
Drinking Excessive
Active, not recruiting
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Men
Drinking Behavior, Drinking Excessive
Not yet recruiting
Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care
Substance Use, Binge Drinking
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.
Hendrik Engelbrecht principal investigator
Tilburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High agency and immediate threat, High agency and distant threat and Low agency and immediate threat in people with Excessive Drinking, run by Tilburg University at 1 site in Netherlands.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 22 Apr 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived self-efficacy (time frame: During the lab session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321238, which also lists 1 linked publication.
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 22 Apr 2022.