Alcohol AbuseNCT06416059
A Mobile Intervention for Black Individuals Who Engage in Hazardous Drinking
A study testing Mobile Application in people with Alcohol Abuse and Anxiety, run by University of Houston at 1 site in United States.
Trial summary
The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to… 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?
- Mobile Application
- 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
- 15 May 2023to 31 Aug 2024
- 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
- 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.
Who cannot join
- 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.
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
Maxwell S Suffis, M.A., 206-795-8350, mssuffis@cougarnet.uh.edu
Michael J Zvolensky, Ph.D.
About this study
Official title: A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking
The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses 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.
Read the 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
- Alcohol Abuse, Anxiety
- Being tested
- Mobile Application
- Keywords
- African American, Black, 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.
Mobile ApplicationBehavioural
The mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety,
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application | Experimental | 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. Receives: Behavioral: Mobile Application |
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). A higher score indicates a worse outcome.
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). A higher score indicates a worse outcome.
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 3-months 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 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).
Measured: Change from Baseline Pre PFI Completion to 3-months 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 3-months 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 posted16 May 2024
- Study start15 May 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (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
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael Zvolensky, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416059
- Sponsor's protocol ID
- STUDY00004389
- Other IDs
- R41AA031398
- Status last verified
- Jun 2024
- First submitted
- 10 May 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile-Delivered Personalized Feedback Intervention for Black Individuals Who Engage in Hazardous Drinking
- ClinicalTrials.gov ID
- NCT06416059
- Acronym / sponsor ID
- STUDY00004389
- Conditions
- Alcohol Abuse, Anxiety
- Keywords
- African American, Black, Personalized Feedback Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 May 2024 (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, mobile health application for the Android and iOS platform. The application uses 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Application | Experimental | Behavioral: Mobile ApplicationParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Mobile ApplicationThe mobile application is a culturally adapted, brief, personalized feedback intervention (PFI) to address alcohol misuse in the context of clinical anxiety, | Behavioural | Mobile Application |
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). A higher score indicates a worse outcome.
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). A higher score indicates a worse outcome.
3 secondary outcomes
Motivation to Reduce Alcohol Consumption Scale
Time frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Modified Drinking Motives Questionnaire-Revised
Time frame: Change from Baseline Pre PFI Completion to 3-months Post PFI Completion
Alcohol Attitudes Scale
Time frame: Change from Baseline Pre PFI Completion to 3-months 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 17 Jun 2024.
- Individual participant dataSharing planned: No. There are currently no plans 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 Zvolensky, Ph.D. 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 Mobile Application in people with Alcohol Abuse and Anxiety, run by University of Houston 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 6 inclusion and 6 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 17 Jun 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 Redmond, Ph.D. (713-743-8056, restorestudy94@gmail.com), 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 17 Jun 2024.