Clinical trial NCT04244461: Brief Online Intervention for Veterans
Official title: Preventing Alcohol Misuse Among Young Adult Veterans Through Brief Online Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Drinking
Mental Health Wellness
Keywords: alcohol
mental health
treatment initiation
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2020-01-28
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* None besides not meeting eligibility criteria

Primary outcomes:
measure: Drinking frequency
timeFrame: Past month (30 days)
measure: Drinks of drinking days
timeFrame: Past month (30 days)
measure: 21-item Brief Young Adult Alcohol Consequences Questionnaire
timeFrame: Past month (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: