Testing a Novel Instagram Intervention for Heavy Alcohol Use

July 22, 2024 updated by: Emily Grekin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Instagram Intervention
Behavioral: Instagram Intervention
The intervention consists of a study Instagram page, which will post intervention content every day for 42 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Given pre-intervention and at 10-week follow-up
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.
Given pre-intervention and at 10-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
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
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).
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
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).
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
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).
Given pre-intervention and at 10-week follow-up
Participant Subjective Reactions Using Likert Scales
Time Frame: Given at 10-week follow-up
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.
Given at 10-week follow-up
Participant Subjective Reactions Using Simple Yes/No Questions
Time Frame: Given at 10-week follow-up
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.).
Given at 10-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emily Grekin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-23-11-6344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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