Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
dementia or severe cognitive impairment per Problem List
significant visual impairment per Problem List
inability to communicate or read in English;
Hearing impairment; and
Trial design
Design model
Parallel
Treatments tested in this trial
MINDSET
BehavioralA 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
Other interventionAll 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.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: MINDSET+UCExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-weeks2
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-weeks3
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-weeksSecondary outcomes
1
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-weeks2
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-weeks3
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-weeks4
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-weeksOther outcomes
1
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 onlySponsors and contacts
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Source ClinicalTrials.gov