## Protocol Section
### Identification Module
**NCT ID:** NCT06416059

**Brief Title:** A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking

**Official Title:** A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking

#### Organization Study ID Info
**ID:** STUDY00004389
#### Organization
**Class:** OTHER
**Full Name:** University of Houston
#### Secondary ID Infos
**ID:** R41AA031398
**Link:** https://reporter.nih.gov/quickSearch/R41AA031398
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

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

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Houston

#### Responsible Party

**Investigator Affiliation:** University of Houston

**Investigator Full Name:** Michael J. Zvolensky, Ph.D.

**Investigator Title:** Distinguished Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to develop and examine a culturally adapted, brief, integrated mobile health application for the Android and iOS platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.

**Detailed Description:** Investigators will develop a culturally adapted, brief, single-session PFI delivered via a mobile health application for the Android and iOS platform through an iterative approach using expert input and semi-structured interview sessions. Next, Black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Black hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via Zoom; baseline and post-treatment data will be collected via Zoom and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

### Conditions Module

**Conditions:**

- Alcohol Abuse

- Anxiety

**Keywords:**

- African American

- Black

- Personalized Feedback Intervention

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants complete a 45 minute intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.

**Intervention Names:**

- Behavioral: Mobile Application

**Label:** Mobile Application

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mobile Application

**Description:** The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety,

**Name:** Mobile Application

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Alcohol Use Disorders Identification Test will be used to assess drinking quantity, craving, and related consequences to alcohol use. The 10 items are rated with various Likert-type scales. The measure produces a total score by adding all of the items of the measure with higher scores indicating greater problems with alcohol (possible range 0 to 40). A higher score indicates a worse outcome.

**Measure:** Alcohol Use Disorders Identification Test

**Time Frame:** Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

**Description:** The 5-item Overall Anxiety Severity and Impairment Scale will be used to assess anxiety symptom severity and impairment. Each of the items is rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score (possible range 0 to 20). A higher score indicates a worse outcome.

**Measure:** Overall Anxiety Severity and Impairment Scale

**Time Frame:** Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

#### Secondary Outcomes

**Description:** The 1-item Motivation to Reduce Alcohol Consumption Scale will be used to measure current motivation/intention to reduce alcohol. Participants will be asked to select the statement that best describes their motivation/intention to reduce drinking (e.g., "I really want to cut down on drinking alcohol and intend to in the next month"). Higher scores on this measure indicate greater motivation/intention to reduce alcohol consumption (possible range (0-7).

**Measure:** Motivation to Reduce Alcohol Consumption Scale

**Time Frame:** Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

**Description:** The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 28-item questionnaire will be used as a measure of expectancies of drinking to reduce/cope with anxiety. The measure utilizes a 5-point Likert scale ranging from 1 (almost never/never) to 5 (almost always/always). Scores are averaged with higher scores indicating greater expectancies of drinking to reduce/cope with anxiety (possible range 1 to 5).

**Measure:** Modified Drinking Motives Questionnaire-Revised

**Time Frame:** Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

**Description:** The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Scores will be averaged to create a composite score (possible range 1 to 7). Higher scores indicate greater maladaptive attitudes for drinking.

**Measure:** Alcohol Attitudes Scale

**Time Frame:** Change from Baseline Pre PFI Completion to 3-months Post PFI Completion

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Being 21 years of age or older
* Self-identifying as Black or African American
* Meeting criteria for current hazardous drinking pattern
* Meeting criteria for clinical anxiety
* Being able to provide written, informed consent
* Owning a smartphone.

Exclusion Criteria:

* Current participation in alcohol or other substance abuse treatment
* Engaged in psychotherapy for anxiety or depression
* Concurrent use of medication for anxiety or depression
* Being pregnant by self-report
* Residence outside of the United States confirmed via survey geolocation
* Inability to provide a valid United States-issued driver's license or identification card to verify identity.

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** byredmond@cougarnet.uh.edu

**Name:** Brooke Y Redmond, Ph.D.

**Phone:** 713-743-8056

**Role:** CONTACT

**Contact 2:**

**Email:** mjzvolen@central.uh.edu

**Name:** Michael J Zvolensky, Ph.D.

**Phone:** 713-743-8595

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** mssuffis@cougarnet.uh.edu

- **Name:** Maxwell S Suffis, M.A.

- **Phone:** 206-795-8350

- **Role:** CONTACT

***Contact 2:***

- **Name:** Michael J Zvolensky, Ph.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Richard A Brown, Ph.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

**State:** Texas

**Status:** RECRUITING

**Zip:** 77204

#### Overall Officials

**Official 1:**

**Affiliation:** University of Houston

**Name:** Michael Zvolensky, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** There are currently no plans to make individual participant data (IPD) available to other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019973

- Term: Alcohol-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M3783

- Name: Alcoholism

- Relevance: HIGH

- As Found: Alcohol Abuse

- ID: M21842

- Name: Alcohol-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000437

- Term: Alcoholism

### 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
