Brief Online Intervention for Veterans

Status Recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04244461
Study type	Interventional
Source	RAND
Contact	Eric Pedersen, Ph.D.
Phone	3103930411
Email	ericp@rand.org
Status	Recruiting
Phase	N/A
Start date	September 30, 2022
Completion date	November 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.