Heavy DrinkingNCT04244461
Brief Online Intervention for Veterans
A study testing Personalized Normative Feedback in people with Heavy Drinking and Mental Health Wellness, run by RAND at 1 site in United States.
Trial summary
The objective of this planned research is to more fully test the efficacy of a very brief, inexpensive, single-session, and web-delivered personalized normative feedback (PNF) intervention evaluated in a successful pilot R34 study to prevent alcohol misuse and associated negative consequences, as well as increase… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking, Mental Health Wellness
- What is being tested?
- Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 30 Nov 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Veterans aged 18 to 40 who has separated/discharged from military service from the Air Force, Army, Marine Corps, or Navy
- Not currently affiliated with active duty service or in the reserves or guard units
- Able to read English (also a requirement of military service)
- Access to a computer, Internet, and personal email address
- No appointments in the past six months and no pending appointments with a mental health professional or medical doctor for treatment of concerns related to alcohol use, other substance use, PTSD, depression, or other mental health concerns
- AUDIT-C scores of 3 or higher (for females) or 4 or higher (for males), which represents a sex-specific positive screen for hazardous and harmful alcohol use, as well as a possible AUD in civilian and military samples
- Separation from the military within the past 5 years.
Who cannot join
- None besides not meeting eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Preventing Alcohol Misuse Among Young Adult Veterans Through Brief Online Intervention
The objective of this planned research is to more fully test the efficacy of a very brief, inexpensive, single-session, and web-delivered personalized normative feedback (PNF) intervention evaluated in a successful pilot R34 study to prevent alcohol misuse and associated negative consequences, as well as increase behavioral health treatment seeking behaviors among a difficult to reach and treatment resistant veteran population. The investigators expand on successful pilot work by (1) building a large publicly available database of young veteran drinking and treatment seeking norms, (2) focusing on reaching veterans who have recently separated from the military and drink heavily but who have not recently sought any behavioral health treatment, (3) evaluating how an enhanced intervention offering PNF content specifically related to treatment seeking affects preparatory behaviors and actual treatment initiation, and (4) testing hypothesized mediators and moderators of intervention drinking and treatment initiation outcomes relevant for this population. In Aim 1, the investigators will add to a large database of drinking norms for the population by collecting drinking and treatment seeking information from veterans underrepresented in the pilot, such as female veterans (total sample N = 2,500). In Aim 2, investigators then use these norms in a randomized controlled trial of the PNF intervention designed to reach heavy drinking young veterans who are not currently receiving behavioral health care (N = 800) and test if additional feedback about treatment seeking can help promote treatment initiation among this treatment resistant group. Outcomes at 3, 6, 9, and 12 months are compared for participants receiving an enhanced PNF condition (N = 400) to an attention-only control condition (N = 400). In Aim 3, the investigators test mediators of intervention efficacy on drinking outcomes (i.e., changes in perceived norms, increases in treatment initiation) and explore moderators of outcomes to determine if the brief intervention works better for veteran participants based on age, gender, reasons for drinking (social versus coping), perceived stigma, posttraumatic stress disorder disorder and depression symptoms, and solitary drinking.
This project is funded by the NIAAA grant R01AA026575.
- Conditions
- Heavy Drinking, Mental Health Wellness
- Being tested
- Personalized Normative Feedback
- Keywords
- alcohol, mental health, treatment initiation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative FeedbackBehavioural
The personalized normative feedback (PNF) focuses on behavioral norms, where participants see (1) how their perceptions compare to other same-gender veterans' actual drinking and (2) how their actual drinking compares to other same-gender veterans' actual drinking. The format of the intervention highlights typical days per week, drinks per occasion, and binge drinking as per traditional PNF interventions. PNF will also contain a video description of theories of normative influence (e.g., how individuals are affected by perceptions) and a description of the normative data sample. Participants also see enhanced PNF content that will focus on sharing with participants treatment information that the investigators obtained from a pilot sample.
| Study group | Role | What they receive |
|---|---|---|
| Personalized normative feedback | Experimental | Personalized feedback about drinking behavior compared to peers Receives: Behavioral: Personalized Normative Feedback |
| Control | No intervention | Control participants will receive content similar in length but different in content from the PNF (i.e., non-drinking focused). These participants will receive information based on their actual and perceived behavior of playing video games, a strategy used in prior PNF work to balance attention to non-targeted behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking frequency
Number of days reported any drinking on the timeline followback
Measured: Past month (30 days)
Drinks of drinking days
Average number of drinks reported during drinking days on the timeline followback
Measured: Past month (30 days)
21-item Brief Young Adult Alcohol Consequences Questionnaire
Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)
Measured: Past month (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Sep 2022
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244461
- Sponsor's protocol ID
- R01AA026575
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pedersen ER, Davis JP, Hummer JF, Bouskill K, Buch KD, Shute IM, Fitzke RE, Tran DD, Neighbors C, Saba S. Reducing Alcohol Misuse and Promoting Treatment Initiation Among Veterans Through a Brief Internet-Based Intervention: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 22;13:e59993. doi: 10.2196/59993.
PubMed 39173142
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol Misuse Among Young Adult Veterans Through Brief Online Intervention
- ClinicalTrials.gov ID
- NCT04244461
- Acronym / sponsor ID
- R01AA026575
- Conditions
- Heavy Drinking, Mental Health Wellness
- Keywords
- alcohol, mental health, treatment initiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 28 Jan 2020 (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 objective of this planned research is to more fully test the efficacy of a very brief, inexpensive, single-session, and web-delivered personalized normative feedback (PNF) intervention evaluated in a successful pilot R34 study to prevent alcohol misuse and associated negative consequences, as well as increase behavioral health treatment seeking behaviors among a difficult to reach and treatment resistant veteran population. The investigators expand on successful pilot work by (1) building a large publicly available database of young veteran drinking and treatment seeking norms, (2) focusing on reaching veterans who have recently separated from the military and drink heavily but who have not recently sought any behavioral health treatment, (3) evaluating how an enhanced intervention offering PNF content specifically related to treatment seeking affects preparatory behaviors and actual treatment initiation, and (4) testing hypothesized mediators and moderators of intervention drinking and treatment initiation outcomes relevant for this population. In Aim 1, the investigators will add to a large database of drinking norms for the population by collecting drinking and treatment seeking information from veterans underrepresented in the pilot, such as female veterans (total sample N = 2,500). In Aim 2, investigators then use these norms in a randomized controlled trial of the PNF intervention designed to reach heavy drinking young veterans who are not currently receiving behavioral health care (N = 800) and test if additional feedback about treatment seeking can help promote treatment initiation among this treatment resistant group. Outcomes at 3, 6, 9, and 12 months are compared for participants receiving an enhanced PNF condition (N = 400) to an attention-only control condition (N = 400). In Aim 3, the investigators test mediators of intervention efficacy on drinking outcomes (i.e., changes in perceived norms, increases in treatment initiation) and explore moderators of outcomes to determine if the brief intervention works better for veteran participants based on age, gender, reasons for drinking (social versus coping), perceived stigma, posttraumatic stress disorder disorder and depression symptoms, and solitary drinking.
This project is funded by the NIAAA grant R01AA026575.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized normative feedback | Experimental | Behavioral: Personalized Normative FeedbackPersonalized feedback about drinking behavior compared to peers |
| Control | No intervention | –Control participants will receive content similar in length but different in content from the PNF (i.e., non-drinking focused). These participants will receive information based on their actual and perceived behavior of playing video games, a strategy used in prior PNF work to balance attention to non-targeted behaviors. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Veterans aged 18 to 40 who has separated/discharged from military service from the Air Force, Army, Marine Corps, or Navy
- Not currently affiliated with active duty service or in the reserves or guard units
- Able to read English (also a requirement of military service)
- Access to a computer, Internet, and personal email address
- No appointments in the past six months and no pending appointments with a mental health professional or medical doctor for treatment of concerns related to alcohol use, other substance use, PTSD, depression, or other mental health concerns
Key exclusion criteria (1 listed)
- None besides not meeting eligibility criteria
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 |
|---|---|---|
| Personalized Normative FeedbackThe personalized normative feedback (PNF) focuses on behavioral norms, where participants see (1) how their perceptions compare to other same-gender veterans' actual drinking and (2) how their actual drinking compares to other same-gender veterans' actual drinking. The format of the intervention highlights typical days per week, drinks per occasion, and binge drinking as per traditional PNF interventions. PNF will also contain a video description of theories of normative influence (e.g., how individuals are affected by perceptions) and a description of the normative data sample. Participants also see enhanced PNF content that will focus on sharing with participants treatment information that the investigators obtained from a pilot sample. | Behavioural | Personalized normative feedback |
Primary outcome
Drinking frequency
Time frame: Past month (30 days)
Number of days reported any drinking on the timeline followback
Drinks of drinking days
Time frame: Past month (30 days)
Average number of drinks reported during drinking days on the timeline followback
21-item Brief Young Adult Alcohol Consequences Questionnaire
Time frame: Past month (30 days)
Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 39173142Pedersen ER, Davis JP, Hummer JF, Bouskill K, Buch KD, Shute IM, Fitzke RE, Tran DD, Neighbors C, Saba S. Reducing Alcohol Misuse and Promoting Treatment Initiation Among Veterans Through a Brief Internet-Based Intervention: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 22;13:e59993. doi: 10.2196/59993.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Normative Feedback in people with Heavy Drinking and Mental Health Wellness, run by RAND 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 1 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: finished, as of the sponsor's last update on 31 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking frequency (time frame: Past month (30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244461, which also lists 1 linked publication.
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 31 Jul 2025.