MINDSET for Alcohol and Tobacco Use in Chronic Conditions

(MINDSET Trial)

Overseen By Jennifer S Funderburk, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Visual impairment, Hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called MINDSET, a behavioral intervention designed to help Veterans with chronic conditions like heart disease or diabetes who smoke or drink excessively. The goal is to determine if sending tailored educational materials and making a motivational phone call can encourage Veterans to change their habits. The trial compares this method to the usual care Veterans receive. Veterans with diabetes, heart disease, or related risk factors who frequently smoke or drink and show reluctance to change might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking and alcohol use, so it's best to discuss your medications with the trial staff.

What prior data suggests that the MINDSET intervention is safe for Veterans with chronic conditions?

In a previous study, researchers explored a method similar to MINDSET, examining how changing people's mindset can affect their alcohol use. This study found no major safety issues, indicating that this type of approach is generally safe.

The MINDSET program involves sending a personalized educational packet and making a motivational phone call to help Veterans consider how smoking and drinking impact their health. Since this approach focuses on behavior and doesn't involve medication, it is usually considered safe. Reports have not indicated any negative effects from this kind of non-drug method.

This trial is in a later stage called Phase 3, which means earlier stages showed the treatment is safe enough to try with more people. This phase often checks how well the treatment works and continues to ensure it is safe. If MINDSET had shown serious safety problems in earlier tests, it would not have reached this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MINDSET intervention for alcohol and tobacco use because it combines personalized health information with behavioral support. Unlike standard care, which typically involves a general assessment and intervention by a primary care team, MINDSET offers tailored health insights delivered through mailed informational packets that specifically address how smoking and drinking impact chronic conditions. Additionally, it features a motivational booster call from a behavioral health provider, providing a more personalized and supportive approach to encourage behavior change. This combination of personalized information and direct support aims to enhance motivation and improve outcomes for individuals struggling with these addictions.

What evidence suggests that MINDSET is effective for alcohol and tobacco use in chronic conditions?

Research has shown that MINDSET, which participants in this trial may receive, can help reduce alcohol and tobacco use. Studies indicate that similar methods boost confidence in changing habits and lead to less drinking and smoking. One study found that motivational interviewing, a conversation type that encourages change, resulted in significant reductions in alcohol use and better treatment participation. Another study showed that people involved in programs like MINDSET were more determined to seek help and improve their habits. Overall, these methods have shown promise in promoting healthier lifestyle changes. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for Veterans with chronic conditions like heart disease or diabetes who also smoke or drink alcohol excessively. They should be individuals who have not shown interest in intensive programs to change these behaviors.

Inclusion Criteria

I have a primary care appointment scheduled during the study period.

I am 18 years old or older.

Veteran

Exclusion Criteria

Inability to communicate or read in English

I have major difficulty seeing.

Cognitive impairment or screening for cognitive impairment (3 errors on Blessed screener)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MINDSET intervention, which includes a mailed informational packet and a motivational telephone call

4 weeks

1 call (telehealth)

Usual Care

Participants receive usual care, which includes a primary care appointment with tobacco/alcohol use assessment and intervention

Ongoing

Follow-up

Participants are monitored for changes in intention to change and substance use

48 weeks

Assessments every 4 weeks, comprehensive assessments every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• MINDSET

Trial Overview The study tests MINDSET, a program involving tailored mail education and motivational calls about the risks of smoking/drinking on their health, against usual care that includes yearly screening and brief advice from providers.

How Is the Trial Designed?

Group I: MINDSET+UC Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07039175

Intervention to Increase Intention to Change Alcohol ... The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10833520/

Creating a psychosocial intervention combining growth ... The authors observed positive effects on perceived self-efficacy, intention to pursue counseling and treatment related to alcohol and drug use.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420302962

A protocol for a randomized controlled trial and pilot study ... Participants in both conditions demonstrated significant reductions in tobacco and alcohol use at the end of treatment. In sum, MBRP-SA had comparable ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6164017/

Mind-Body Approaches to Prevention and Intervention for ... Alcohol and other drug (AOD) misuse is highly prevalent among young adults and creates myriad long-term problematic social, economic, and health ...

5. case.edu case.edu/socialwork/centerforebp/sites/default/files/2024-11/MI%20and%20MET%20for%20AUD%20Full%20Report-09242024-upd-11-15-2024.pdf

Motivational interviewing and motivational enhancement ... Several studies found that MI and MET led to significant reductions in alcohol use, binge or heavy drinking, and high treatment retention.

6. nature.com nature.com/articles/s41598-023-38478-y

Psychological distance intervention reminders reduce ... We find that smartphone-based mindfulness and perspective-taking interventions, aimed to create psychological distance, can change behavior.

7. link.springer.com link.springer.com/article/10.1007/s00181-023-02483-x

The causal impact of mental health on tobacco and alcohol ... We find that mental distress significantly increases the prevalence and intensity of either cigarette or alcohol consumption.