Heavy DrinkingNCT06420050
Testing a Novel Instagram Intervention for Heavy Alcohol Use
A study testing Instagram Intervention in people with Heavy Drinking, run by Emily Grekin at 1 site in United States.
Trial summary
This project aims to test the efficacy of an Instagram-based intervention for reducing heavy alcohol use. More specifically, the investigators will use a randomized controlled design to analyze differences in alcohol use and alcohol-related outcomes (e.g., alcohol-related consequences, etc.) as well as differences in… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Instagram Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2024to 30 Dec 2024
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-30
- Report regular Instagram usage (i.e., at least a few times a week)
- Report having met the NIAAA's criteria for a binge-drinking episode (4+ drinks in a sitting for cisgender women, 5+ drinks in a sitting for all other genders) at least twice a month for the past three month
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Novel Instagram Intervention for Heavy Alcohol Use: A Randomized Controlled
This project aims to test the efficacy of an Instagram-based intervention for reducing heavy alcohol use. More specifically, the investigators will use a randomized controlled design to analyze differences in alcohol use and alcohol-related outcomes (e.g., alcohol-related consequences, etc.) as well as differences in the use of protective behavioral strategies and mindfulness practices. Participants (80 Prolific users who report binge drinking) will be randomly assigned to 1 of 3 conditions: intervention or control. Those who are randomized to the intervention condition will be invited to follow study Instagram pages, and those who are randomized to the control condition will be invited to complete the assessments only. The investigators hypothesize that there will be greater reductions in alcohol use, frequency, and consequences and greater frequency of use of mindfulness exercises and protective behavioral strategies among those in the intervention condition as compared to those in the control condition.
- Conditions
- Heavy Drinking
- Being tested
- Instagram Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instagram InterventionBehavioural
The intervention consists of a study Instagram page, which will post intervention content every day for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Instagram Intervention | Experimental | Not described Receives: Behavioral: Instagram Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back
The investigators will analyze differences in the amount of days spent drinking.
Measured: Given pre-intervention and at 10-week follow-up
Change in Quantity of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back
The investigators will analyze differences in amount of past-month alcohol use and the amount of past-month binge-drinking episodes.
Measured: Given pre-intervention and at 10-week follow-up
Secondary outcomes (6)
Change in Frequency of Protective Behavioral Strategy Use Using the Protective Drinking Practices Scale
The investigators will analyze the difference in frequency of recent protective behavioral strategy use using the Protective Drinking Practices Scale (minimum score = 20, maximum score = 120, and higher scores indicate a better outcome).
Measured: Given pre-intervention and at 10-week follow-up
Change in the Amount of Recent Alcohol Consequences Using the Brief Young Adult Consequences Scale
The investigators will analyze the difference in amount of consequences related to alcohol use using the Brief Young Adult Consequences Scale (minimum score = 0, maximum score = 24, and higher scores indicate a worse outcome).
Measured: Given pre-intervention and at 10-week follow-up
Change in Frequency of Mindfulness Practice Use Using the Mindfulness Awareness Scale
The investigators will analyze the difference in frequency of use of mindfulness practices using the Mindfulness Awareness Scale (minimum score = 15, maximum score = 90, and higher scores indicate a better outcome).
Measured: Given pre-intervention and at 10-week follow-up
Change in Readiness to Change Drinking Behavior Using the Readiness to Change Questionnaire
The investigators will analyze the difference in reported readiness to change drinking behavior using the Readiness to Change Questionnaire (minimum score = 12, maximum score = 84, and higher scores indicate a better outcome).
Measured: Given pre-intervention and at 10-week follow-up
Participant Subjective Reactions Using Likert Scales
The investigators will ask participants to rate the intervention content on acceptability dimensions created specifically for this study (i.e., relevance, empathy, interest, helpfulness, respectfulness, personalization). On a given domain, minimum score = 1, maximum score = 5, and higher scores indicate better outcomes.
Measured: Given at 10-week follow-up
Participant Subjective Reactions Using Simple Yes/No Questions
The investigators will ask participants to rate how the intervention has qualitatively impacted them using simple yes/no questions (i.e., if they remember seeing certain posts, if the posts made them think about their drinking, affected their sense of community, etc.).
Measured: Given at 10-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start22 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emily Grekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emily Grekin, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420050
- Sponsor's protocol ID
- IRB-23-11-6344
- Status last verified
- Jul 2024
- First submitted
- 10 Apr 2024
- Last updated
- 24 Jul 2024
- Results posted
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Novel Instagram Intervention for Heavy Alcohol Use: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT06420050
- Acronym / sponsor ID
- IRB-23-11-6344
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emily GrekinUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 May 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.
This project aims to test the efficacy of an Instagram-based intervention for reducing heavy alcohol use. More specifically, the investigators will use a randomized controlled design to analyze differences in alcohol use and alcohol-related outcomes (e.g., alcohol-related consequences, etc.) as well as differences in the use of protective behavioral strategies and mindfulness practices. Participants (80 Prolific users who report binge drinking) will be randomly assigned to 1 of 3 conditions: intervention or control. Those who are randomized to the intervention condition will be invited to follow study Instagram pages, and those who are randomized to the control condition will be invited to complete the assessments only. The investigators hypothesize that there will be greater reductions in alcohol use, frequency, and consequences and greater frequency of use of mindfulness exercises and protective behavioral strategies among those in the intervention condition as compared to those in the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instagram Intervention | Experimental | Behavioral: Instagram Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-30
- Report regular Instagram usage (i.e., at least a few times a week)
- Report having met the NIAAA's criteria for a binge-drinking episode (4+ drinks in a sitting for cisgender women, 5+ drinks in a sitting for all other genders) at least twice a month for the past three month
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Instagram InterventionThe intervention consists of a study Instagram page, which will post intervention content every day for 42 days. | Behavioural | Instagram Intervention |
Primary outcome
Change in Frequency of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back
Time frame: Given pre-intervention and at 10-week follow-up
The investigators will analyze differences in the amount of days spent drinking.
Change in Quantity of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back
Time frame: Given pre-intervention and at 10-week follow-up
The investigators will analyze differences in amount of past-month alcohol use and the amount of past-month binge-drinking episodes.
6 secondary outcomes
Change in Frequency of Protective Behavioral Strategy Use Using the Protective Drinking Practices Scale
Time frame: Given pre-intervention and at 10-week follow-up
Change in the Amount of Recent Alcohol Consequences Using the Brief Young Adult Consequences Scale
Time frame: Given pre-intervention and at 10-week follow-up
Change in Frequency of Mindfulness Practice Use Using the Mindfulness Awareness Scale
Time frame: Given pre-intervention and at 10-week follow-up
Change in Readiness to Change Drinking Behavior Using the Readiness to Change Questionnaire
Time frame: Given pre-intervention and at 10-week follow-up
Participant Subjective Reactions Using Likert Scales
Time frame: Given at 10-week follow-up
Participant Subjective Reactions Using Simple Yes/No Questions
Time frame: Given at 10-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- 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. 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 Instagram Intervention in people with Heavy Drinking, run by Emily Grekin at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. 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 United States. 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?
Results are not available in the source record.
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?
Change in Frequency of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back (time frame: Given pre-intervention and at 10-week follow-up). 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?
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 24 Jul 2024.