Recruiting

Phase 3

MINDSETIntervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease

Sponsor:

VA Office of Research and Development

Code:

NCT07039175

Conditions

Tobacco Smoking

Alcohol-Related Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MINDSET

Usual Care

Study Details

Brief summary:

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.

Conditions

Tobacco Smoking

Alcohol-Related Disorders

Study ID

NCT07039175

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not).
Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not).
Veteran
Age 18 years
utilize VA for medical care more than 1 time per year
are due to complete their smoking/alcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period)
a scheduled PC appointment within the intervention period.

Exclusion Criteria:

dementia or severe cognitive impairment per Problem List
significant visual impairment per Problem List
Other Exclusion criteria assessed by study staff during screening/self-report are:

inability to communicate or read in English;
Hearing impairment; and
cognitive impairment or screening for cognitive impairment (>=weighted score of 10 on Blessed screener).

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MINDSET+UC

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.

active comparator: Usual Care

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.

Interventions

MINDSET

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.

Usual Care

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.

Primary outcome measure

Theory of Planned Behavior Intention subscale [ 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 [ 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 [ 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 ]

Central Contacts and Locations

Central contacts

Julie C Gass, PhD

(716) 834-9200 Julie.Gass@va.gov

Jennifer S Funderburk, PhD

(315) 425-4400 Jennifer.Funderburk@va.gov

Locations

VA Western New York Healthcare System, Buffalo, NY

Recruiting

Buffalo, New York, United States, 14215-1129

Contacts

Mary A Blake

(716) 862-6527 mary.blake@va.gov

Ali A El-Solh, MD MPH

(716) 862-6528 ali.el-solh@va.gov

Principal Investigator:

Julie Christina Gass, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

Chronic Disease
Smoking
Drinking, Alcohol
Cardiovascular Risk
Health Behavior
Medicine, Behavioral
telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-31.