One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.
1) diagnosed with an alcohol use disorder (AUD) and report 4 heavy drinking days (HDD)
(defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days
2) enrolled in VA primary care
3) planning to initiate medications for alcohol use disorder (MAUD), as determined by a medication order
1) past 30-day participation in VA or non-VA substance use disorder (SUD) treatment
2) prior episode of medications for alcohol use disorder receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed)
3) plans to be or are pregnant
4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged >80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter substance use disorder specialty care following randomization will be allowed to continue in the study.
Parallel
Stand Down mobile app
Other interventionThe Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
Standard Care
Other interventionParticipants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.
Change in Percent Heavy Drinking Days (HDD)
Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as \>4 drinks per day for women and \>5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
Semi-structured qualitative interview data from patients, providers, clinical leaders
\[Qualitative\] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.
Change in Short Inventory of Problems - Revised version (SIP-R)
Change from baseline to 6-month follow-up in the Short Inventory of Problems - Revised version (SIP-R), a 17-item questionnaire used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 1= Once or a Few Times, 2 = Once or Twice a Week, 3 = Daily or Almost Daily), which yields a total score. Higher scores reflect greater severity of alcohol-related problems.
Change in World Health Organization (WHO) Risk Levels
Change from baseline to 6-month follow-up in WHO risk levels, which are defined by average grams of alcohol consumed per day as calculated for each participant from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Participants are categorized into five levels: abstinent (0 g of alcohol/day), low risk (1-40 g/1-20 g of alcohol/day), medium risk (41-60 g/21-40 g of alcohol/day), high risk (61-100 g/41-60 g of alcohol/day), and very high risk (\>101 g/\>61 g of alcohol/day), with 14g of alcohol being equivalent to 1 standard drink. Reductions in WHO risk levels have been associated with significant improvements in liver function, AUD severity, and functioning among persons with AUD. WHO risk levels are reported as the percentage of participants in each study group representing each risk level.
Change in Client Satisfaction Questionnaire (CSQ) Scores
Change from baseline to 6-month follow-up in the Client Satisfaction Questionnaire (CSQ), an 8-item questionnaire used to assess patient satisfaction with substance use treatment. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
Change from baseline to 6-month follow-up in the PHQ-9, a 9-item instrument used to screen, diagnose, and monitor the severity of depression. Each item is rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.
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