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

NCT07039175 | Recruiting Phase 3 DMC

• 2 other identifiers: IIR 23-1701IOHX003901
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  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

Secondary Outcomes (4)

• Timeline Followback

  Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks

• Theory of Planned Behavior Action Planning subscale

  Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks

• Theory of Planned Behavior Quitting Behaviors subscale

  Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks

• Readiness to Access Help scale plus Help-Seeking for Alcohol-Related Problems Scale

  Baseline, 12-weeks, 24-weeks, 36-weeks, 48-weeks

Other Outcomes (1)

• Client Satisfaction Questionnaire

  24-week post assessment only

Study Arms (2)

MINDSET+UC

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

MINDSET BEHAVIORAL

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

MINDSET+UC

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking; Alcohol-Related Disorders; Chronic Disease; Smoking; Alcohol Drinking; Health Behavior; Behavior

Interventions

Stress Mindset Measure; Self-Management; Educational Status

Condition Hierarchy (Ancestors)

Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drinking Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Julie Christina Gass, PhD

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

• Jennifer S Funderburk, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie C Gass, PhD

CONTACT

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

Jennifer S Funderburk, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blinded to the condition of the Veteran at all assessment time points.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants recruited from VAs across the country will be randomized to receive usual care + MINDSET or usual care alone.

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)