Alcohol AbuseNCT05288699
Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety
A study testing Aliento in people with Alcohol Abuse and Anxiety, run by Michael J. Zvolensky, Ph.D. at 1 site in United States.
Trial summary
The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Abuse, Anxiety
- What is being tested?
- Aliento
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 30 Apr 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- self-identified as Latinx or Hispanic
- fluent in Spanish
- current hazardous drinking pattern
- current clinical anxiety
- able to provide written, informed consent
- owning an Android smartphone
Who cannot join
- currently involved in alcohol or other substance use program
- concurrent use of medication for anxiety or depression
- current engagement in psychotherapy for anxiety or depression
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
Houston, Texas, 77204
Aniqua Salwa, B.A., 713-743-8056, asalwa@central.uh.edu
Michael J Zvolensky, Ph.D.
About this study
Official title: Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention
The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android 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 Latinx hazardous drinkers with clinical anxiety.
Read the detailed description
Investigators will develop a culturally adapted, brief, single-session, Spanish language, PFI delivered via a mobile health application for the Android platform through an iterative approach using expert input and focus groups. Next, Latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Latinx 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 telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.
- Conditions
- Alcohol Abuse, Anxiety
- Being tested
- Aliento
- Keywords
- Latinx, Hispanic, Personalized Feedback Intervention
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlientoBehavioural
Aliento is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety delivered via a mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Aliento | Experimental | Participants complete the brief (~30 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. Receives: Behavioral: Aliento |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
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).
Measured: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Secondary outcomes (3)
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).
Measured: Change from Baseline Pre PFI completion to Baseline Post PFI completion
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).
Measured: Change from Baseline Pre PFI completion to Baseline Post PFI completion
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.
Measured: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start4 Nov 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Zvolensky, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael J Zvolensky, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288699
- Sponsor's protocol ID
- STUDY00003577
- Status last verified
- May 2024
- First submitted
- 10 Mar 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Personalized Feedback Intervention for Latinx Hazardous Drinkers: A Community-Based Intervention
- ClinicalTrials.gov ID
- NCT05288699
- Acronym / sponsor ID
- STUDY00003577
- Conditions
- Alcohol Abuse, Anxiety
- Keywords
- Latinx, Hispanic, Personalized Feedback Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Michael J. Zvolensky, Ph.D.University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Mar 2022 (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.
The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android 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 Latinx hazardous drinkers with clinical anxiety.
Detailed description
Investigators will develop a culturally adapted, brief, single-session, Spanish language, PFI delivered via a mobile health application for the Android platform through an iterative approach using expert input and focus groups. Next, Latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Latinx 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 telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliento | Experimental | Behavioral: AlientoParticipants complete the brief (~30 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21 years of age or older
- self-identified as Latinx or Hispanic
- fluent in Spanish
- current hazardous drinking pattern
- current clinical anxiety
Key exclusion criteria (3 listed)
- currently involved in alcohol or other substance use program
- concurrent use of medication for anxiety or depression
- current engagement in psychotherapy for anxiety or depression
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 |
|---|---|---|
| AlientoAliento is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety delivered via a mobile application. | Behavioural | Aliento |
Primary outcome
Alcohol Use Disorders Identification Test
Time frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
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).
Overall Anxiety Severity and Impairment Scale
Time frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
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).
3 secondary outcomes
Motivation to Reduce Alcohol Consumption Scale
Time frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Modified Drinking Motives Questionnaire-Revised
Time frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Alcohol Attitudes Scale
Time frame: Change from Baseline Pre PFI completion to Baseline Post PFI completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Michael J Zvolensky principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliento in people with Alcohol Abuse and Anxiety, run by Michael J. Zvolensky, Ph.D. 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 7 inclusion and 3 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 14 May 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?
Contact Brooke Y Kauffman, Ph.D. (713-743-8056, bkauffma@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorders Identification Test (time frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion). 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 14 May 2024.