## Protocol Section
### Identification Module
**NCT ID:** NCT06420050

**Brief Title:** Testing a Novel Instagram Intervention for Heavy Alcohol Use

**Official Title:** Testing a Novel Instagram Intervention for Heavy Alcohol Use: A Randomized Controlled

#### Organization Study ID Info
**ID:** IRB-23-11-6344
#### Organization
**Class:** OTHER
**Full Name:** Wayne State University
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Emily Grekin

#### Responsible Party

**Investigator Affiliation:** Wayne State University

**Investigator Full Name:** Emily Grekin

**Investigator Title:** Associate Chair

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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 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 Module

**Conditions:**

- Heavy Drinking

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Instagram Intervention

**Label:** Instagram Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Instagram Intervention

**Description:** The intervention consists of a study Instagram page, which will post intervention content every day for 42 days.

**Name:** Instagram Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will analyze differences in the amount of days spent drinking.

**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

**Description:** The investigators will analyze differences in amount of past-month alcohol use and the amount of past-month binge-drinking episodes.

**Measure:** 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

#### Secondary Outcomes

**Description:** 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).

**Measure:** 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

**Description:** 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).

**Measure:** 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

**Description:** 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).

**Measure:** Change in Frequency of Mindfulness Practice Use Using the Mindfulness Awareness Scale

**Time Frame:** Given pre-intervention and at 10-week follow-up

**Description:** 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).

**Measure:** Change in Readiness to Change Drinking Behavior Using the Readiness to Change Questionnaire

**Time Frame:** Given pre-intervention and at 10-week follow-up

**Description:** 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.

**Measure:** Participant Subjective Reactions Using Likert Scales

**Time Frame:** Given at 10-week follow-up

**Description:** 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.).

**Measure:** Participant Subjective Reactions Using Simple Yes/No Questions

**Time Frame:** Given at 10-week follow-up

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** halle.a.thomas@wayne.edu

**Name:** Halle Thomas, M.A.

**Phone:** 734-883-2669

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Detroit

**Country:** United States

**Facility:** Wayne State University

**State:** Michigan

**Zip:** 48202

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-09-22

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 9347442

- Type Abbrev: Prot_SAP

- Upload Date: 2024-04-18T11:10

- Date: 2024-02-12

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 213008

- Type Abbrev: ICF

- Upload Date: 2024-04-04T10:14

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004327

- Term: Drinking Behavior

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3774

- Name: Alcohol Drinking

- Relevance: HIGH

- As Found: Alcohol Use

- ID: M7502

- Name: Drinking Behavior

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000428

- Term: Alcohol Drinking

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
