A Phase 3 interventional study of MINDSET and Usual Care in Tobacco Smoking and Alcohol-Related Disorders, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by VA Office of Research and Development · Phase 3, Interventional, and Treatment
Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.
Background: Chronic diseases are prevalent, costly, and have been linked to increased risk of mortality and morbidity in Veterans. Hazardous alcohol use and cigarette smoking can significantly exacerbate these negative consequences for Veterans. To help mitigate risk, VHA primary care health initiatives have prioritized hazardous alcohol use and cigarette smoking and have mandated that patients be annually screened and receive a brief intervention (primary care intervention delivered by the patient-aligned care team; PACT) if positive. However, many Veterans continue to smoke and/or hazardously drink. Current VHA treatment options do not meet the needs of these reticent Veterans. Motivational Intervention Designed for Self-management and EducaTion (MINDSET) is an evidence-based, remote, low-resource intervention that uses a motivational approach to increase change intentions within the context of their chronic disease.
Significance: Most healthcare costs come from Veterans with chronic diseases (e.g., cardiovascular disease; CVD), which are worsened by hazardous alcohol use and smoking. This research addresses multiple VHA priorities through its focus on increasing access to care for a subgroup of reticent Veterans with chronic disease. MINDSET's integrated focus on smoking and hazardous drinking in the context of chronic disease management aligns with Veteran's priorities, and diabetes and CVD were a top ranked health concern by Veterans. This work is also very well aligned with several HSR\&D Priorities, including Complex Chronic Disease Management, Mental \& Behavioral Health, Women's Health, Aging, and Access to Care.
Innovation \& Impact: MINDSET's design, which recognizes the competing demands within medical settings, intentionally utilizes universal and accessible dissemination methods (e.g., mail and telephone) to decrease burden while increasing reach and impact. This study uniquely fills a gap in VHA and HSR\&D research as there are no evidence-based interventions tailored for this subgroup of reticent Veterans who smoke and/or drink above recommended limits and have co-occurring CVD, cardiac risk factors, and/or diabetes. The impact potential is high, as moving this subgroup of reticent Veterans toward changing smoking/hazardous drinking will dramatically decrease their health risks and healthcare costs.
Specific Aims: The proposed work will evaluate MINDSET+usual care (UC) in comparison to UC alone (brief primary care advice) on precursors to change (i.e., behavioral control, intention to change), and substance consumption.
Methodology: The investigators will conduct a type 1 hybrid effectiveness-implementation RCT, where enrolled Veterans will be randomized to either the intervention condition UC (i.e., primary care brief advice) alone or (usual care [UC]+MINDSET). Assessments will occur every 4 weeks, with comprehensive assessments every 3 months for one year. The investigators will utilize a stratified block randomization method based on whether Veterans report only smoking, only hazardously drinking, or both. The investigator's primary outcome will assess participants' intention to change each behavior separately, and a total summed score across items divided by the number of items endorsed (based on behaviors engaged in) will be utilized to summarize their overall intention to change. It is important to note that Veterans will be recruited nationally for this fully telehealth-based study.
Next Steps/Implementation: If MINDSET is effective, additional implementation research/efforts will be proposed.
68 studies on the registry are indexed under Tobacco Smoking; 26 are open to participants now.
This study's planned enrollment of 270 is above the median of 111 across 60 interventional studies indexed under Tobacco Smoking.
Browse Tobacco Smoking studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other Exclusion criteria assessed by study staff during screening/self-report are:
Within one month following a standard primary care appointment (which comprises usual care; UC), Veterans in this condition will receive the MINDSET intervention which consists of: a behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.
Behavioral: MINDSET
All Veterans in this study will have a primary care appointment during which their primary care team will administer whatever tobacco/alcohol use assessment and intervention they typically would.
Other: Usual Care
A behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.
Also known as: Motivational INtervention Designed for Self-management and EducaTion
All Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations/interventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking/drinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion/intervention at all to extensive conversations with the provision of medications, brief advice, etc.
Also known as: UC
Theory of Planned Behavior Intention subscale
3 items regarding intention to change measured on a 7-point Likert-type scale from (1) very unlikely to (7) very likely.
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Readiness to Change Ruler
A one-item 11-point (0-10) ruler with the following anchors: "I never think about my drinking/smoking" at 0 to "I now drink/smoke less than before" at 10
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Theory of Planned Behavior Perceived Behavioral Control Subscale
4 items measured on a 1-7 point Likert-type scale. The four items include two related to self-efficacy and two to controllability, as recommended by guidelines for developing TBP-related measurements.
Time frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks
Timeline Followback
A verbal/guided measure that guides Veterans Veterans through the last 90 days reporting how many drinks or cigarettes they had each day.
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Action Planning subscale
4 items (e.g., I have been thinking about when I'm going to change) that measure planning/action behaviors toward change based on TBP rated on a 7-point Likert-type scale from (1) completely wrong to (7) complete correct.
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Theory of Planned Behavior Quitting Behaviors subscale
3 dichotomous face-valid questions to assess the participants quitting/change behaviors (e.g., "I have quit") on a yes-no scale
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Readiness to Access Help scale plus Help-Seeking for Alcohol-Related Problems Scale
6-items that will be used to assess any help seeking behaviors (e.g., accessing self-help resources) that has already occurred on a 11-point Likert-scale. Two additional items adapted from the Help-Seeking for Alcohol-Related Problems in College Students Scale106 will be included attending group meetings and calling a counselor or doctor.
Time frame: Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks
Client Satisfaction Questionnaire
8-item self-report questionnaire on patient satisfaction with medical and mental health interventions, with higher scores indicating higher satisfaction.
Time frame: 24-week post assessment only
Plan to share: No
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