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MINDSET Intervention for Veterans with Chronic Disease and Alcohol/Tobacco Use

This study is testing an intervention called MINDSET for Veterans who have chronic conditions like diabetes or heart disease and also smoke or drink too much alcohol. MINDSET involves a mailed information packet tailored to your health, explaining how smoking/drinking affects your condition and the benefits of stopping. This is followed by a brief phone call from a behavioral health provider. The study aims to see if MINDSET can increase your intention to change your alcohol or tobacco use. You can join if you are an adult Veteran with diabetes, cardiovascular disease, high blood pressure, or high cholesterol, and have shown some hesitation about changing your smoking or drinking habits. The study is currently unclear on its recruitment status and plans to enroll 270 participants.

Study design
This interventional study plans to enroll 270 participants. It compares the MINDSET intervention to usual care, which includes standard primary care appointments.
What's involved
You would complete surveys at baseline, and then every 4 weeks for 48 weeks, totaling 13 survey points over almost a year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 48 weeks after starting the study interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07039175

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
VA Office of Research and Development
~270 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:MINDSETUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Theory of Planned Behavior Intention subscale
Measured over 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
+2 more outcomes measured

Conditions

Tobacco Smoking
Alcohol-Related Disorders

Explore related trials

Alcohol Related DisordersCardiovascular DisorderDiabetes MellitusHyperlipidemiaHypertensionTobacco Smoking

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Julie Christina Gass, PhD · PRINCIPAL_INVESTIGATOR · VA Western New York Healthcare System, Buffalo, NY
  • Jennifer S Funderburk, PhD · PRINCIPAL_INVESTIGATOR · Syracuse VA Medical Center, Syracuse, NY

Who to contact

Julie C Gass, PhD
[email protected]
(716) 834-9200 · ext. 5429
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

dementia or severe cognitive impairment per Problem List
significant visual impairment per Problem List
inability to communicate or read in English;
Hearing impairment; and
cognitive impairment or screening for cognitive impairment (\>=weighted score of 10 on Blessed screener).

What this trial measures

  • Theory of Planned Behavior Intention subscaleBaseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks

    3 items regarding intention to change measured on a 7-point Likert-type scale from (1) very unlikely to (7) very likely.

  • Readiness to Change RulerBaseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks

    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

  • Theory of Planned Behavior Perceived Behavioral Control SubscaleBaseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks

    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.