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Personalized Feedback Intervention for Latinx Drinkers With Anxiety

Primary Purpose

Alcohol Abuse, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol-Anxiety Personalized Feedback Intervention 2.0
Control Personalized Feedback Intervention
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Latinx, Hispanic, Personalized Feedback Intervention

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being between the age of 21 to 75 years of age
  • Being self-identified as Latinx or Hispanic
  • Fluent in Spanish
  • Meeting criteria for current hazardous drinking pattern
  • Meeting criteria for clinical anxiety
  • Being able to provide written, informed consent

Exclusion Criteria:

  • Being involved in alcohol or other substance use program
  • Currently pregnant
  • Current engagement in psychotherapy for anxiety

Sites / Locations

  • RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial EquityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)

Control personalized feedback intervention (C-PFI)

Arm Description

Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline.

Participants complete the brief (~20-30 minute) C-PFI at baseline.

Outcomes

Primary Outcome Measures

Motivation to Reduce Alcohol Consumption Scale
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).
Modified Drinking Motives Questionnaire-Revised
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale 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).
Alcohol Attitudes Scale
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.

Secondary Outcome Measures

Overall Anxiety Severity and Impairment Scale
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).
Alcohol Use Disorders Identification Test
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).

Full Information

First Posted
November 29, 2021
Last Updated
October 24, 2022
Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05246202
Brief Title
Personalized Feedback Intervention for Latinx Drinkers With Anxiety
Official Title
Latinx Hazardous Drinkers With Clinical Anxiety: Effectiveness Trial of a Personalized Normative Feedback Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted 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 Latinx hazardous drinkers with anxiety.
Detailed Description
In the first phase, the investigators will collect qualitative and quantitative feedback from focus groups to refine intervention content and evaluate treatment acceptability and feasibility of a novel, brief, integrated, culturally adapted computer-based personalized feedback intervention (PFI). In the second phase, Latinx hazardous drinkers with clinical anxiety will be recruited and randomly assigned to either the refined culturally adapted anxiety-alcohol PFI (AA-PFI 2.0) or a control PFI (C-PFI). Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-, 3-, and 6-month follow-up data will be collected online remotely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Anxiety
Keywords
Latinx, Hispanic, Personalized Feedback Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anxiety-alcohol personalized feedback intervention (AA-PFI 2.0)
Arm Type
Experimental
Arm Description
Participants complete the brief (~20-30 minute) AA-PFI 2.0 at baseline.
Arm Title
Control personalized feedback intervention (C-PFI)
Arm Type
Active Comparator
Arm Description
Participants complete the brief (~20-30 minute) C-PFI at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol-Anxiety Personalized Feedback Intervention 2.0
Other Intervention Name(s)
AA-PFI 2.0
Intervention Description
AA-PFI 2.0 is a culturally adapted, brief, computer-delivered, personalized feedback intervention to address alcohol misuse in the context of clinical anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Control Personalized Feedback Intervention
Other Intervention Name(s)
C-PFI
Intervention Description
C-PFI is a brief, computer-delivered, personalized feedback intervention on exercise and nutrition.
Primary Outcome Measure Information:
Title
Motivation to Reduce Alcohol Consumption Scale
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).
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion
Title
Modified Drinking Motives Questionnaire-Revised
Description
The Modified Drinking Motives Questionnaire-Revised will be used to assess expectancies of drinking. For the current study, the 4-item "Coping-anxiety" subscale 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).
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion
Title
Alcohol Attitudes Scale
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.
Time Frame
Change from Baseline Pre PFI completion to Baseline Post PFI completion
Secondary Outcome Measure Information:
Title
Overall Anxiety Severity and Impairment Scale
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).
Time Frame
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion
Title
Alcohol Use Disorders Identification Test
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).
Time Frame
Change from Baseline Pre PFI Completion to 6-months Post PFI Completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between the age of 21 to 75 years of age Being self-identified as Latinx or Hispanic Fluent in Spanish Meeting criteria for current hazardous drinking pattern Meeting criteria for clinical anxiety Being able to provide written, informed consent Exclusion Criteria: Being involved in alcohol or other substance use program Currently pregnant Current engagement in psychotherapy for anxiety
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Y Kauffman, Ph.D.
Phone
713-743-8056
Email
bkauffma@central.uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aniqua Salwa, B.A.
Phone
713-743-8056
Email
asalwa@central.uh.edu
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

Personalized Feedback Intervention for Latinx Drinkers With Anxiety

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