Telehealth Cognitive Behavioral Therapy for Alcohol Abuse with Cardiovascular Risk

(ACME-TM Trial)

Overseen By Daniel Blalock, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Hypertension, Hyperlipidemia, Diabetes

Disqualifiers: Severe alcohol dependence, Palliative care, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on an appropriate medication regimen for cardiovascular disease prevention, which will be reviewed by a research coordinator and a doctor.

Is telehealth cognitive behavioral therapy for alcohol abuse with cardiovascular risk safe for humans?

Research on telehealth interventions, including those for cardiovascular disease, suggests they are generally safe and can help reduce risk factors. These programs often use technologies like the internet and smartphones, which have been well-received by patients and shown potential positive effects on health outcomes. ^{1 2 3 4 5}

How is the Telehealth CBT for Alcohol Misuse and CVD Risk treatment different from other treatments?

This treatment is unique because it combines cognitive-behavioral therapy (CBT) with telehealth and mobile health (mHealth) technologies to address both alcohol misuse and cardiovascular disease (CVD) risk, offering a convenient and accessible way to manage these conditions together, unlike traditional in-person therapies. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Telehealth Cognitive Behavioral Therapy for Alcohol Abuse with Cardiovascular Risk?

Research shows that telehealth interventions can help manage cardiovascular risk factors and improve access to cardiac rehabilitation, which is often underutilized due to geographical barriers. These findings suggest that using telehealth for cognitive-behavioral therapy could be effective in addressing both alcohol misuse and cardiovascular risk by making treatment more accessible. ^{1 2 5 9 10}

Who Is on the Research Team?

Daniel Blalock, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans with uncontrolled high blood pressure, hyperlipidemia, or diabetes who misuse alcohol. They must be enrolled in specific VA clinics, have a history of these conditions for at least a year, take medication for them, and have access to text messaging. Excluded are those in other CVD or alcohol treatment trials, with severe alcohol dependence or significant withdrawal symptoms.

Inclusion Criteria

Self-reported access to any SMS text-capable phone.

My medication for heart disease prevention has been approved by the research team.

Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.

Exclusion Criteria

I don't have any upcoming surgeries or need major changes to my medications.

I am currently receiving palliative care or am in a nursing/hospice home.

EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse, followed by a 5th telehealth coaching call to develop a plan for cardiovascular risk factors. Participants then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.

6 weeks

5 telehealth sessions, daily text messages for 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of treatment acceptability and SMS text acceptability.

10 weeks

Post-treatment assessments

Long-term Follow-up

Participants' systolic blood pressure and self-reported heavy drinking days are monitored to assess long-term outcomes.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)

Trial Overview The ACME-TM program combines cognitive-behavioral therapy via telehealth and mobile health technologies to reduce alcohol misuse and improve cardiovascular health behaviors among veterans. It includes personalized text messages and coaching calls focused on transitioning treatment targets.

How Is the Trial Designed?

Group I: ACME-TM Experimental Treatment 1 Intervention

Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.

Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) is already approved in United States for the following indications:

Approved in United States as ACME-TM for:

• Alcohol misuse
• Cardiovascular disease risk reduction

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Telehealth interventions for patients with coronary heart disease (CHD) significantly reduced rehospitalization and cardiac events compared to usual care, indicating their effectiveness in secondary prevention.

While telehealth did not show a significant reduction in all-cause mortality compared to cardiac rehabilitation, it was associated with improvements in modifiable risk factors like cholesterol levels and smoking status, suggesting it can be a valuable alternative or addition to traditional rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth interventions for the secondary prevention of coronary heart disease: A systematic review and meta-analysis. Jin, K., Khonsari, S., Gallagher, R., et al.[2023]

Telehealth interventions for cardiac rehabilitation (CR) show similar effectiveness to traditional center-based supervised CR in patients with coronary artery disease, with no significant differences in key health outcomes such as exercise capacity, weight, and blood pressure.

This review of nine trials involving patients primarily with myocardial infarction or revascularization suggests that telehealth CR can be a viable alternative for those who may have difficulty accessing traditional rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis. Huang, K., Liu, W., He, D., et al.[2022]

Telehealth has strong evidence supporting its use for acute cardiac care, acute stroke treatment, and cardiac rehabilitation, suggesting it can help improve cardiovascular outcomes for disadvantaged groups in Australia.

While telehealth can provide value for managing chronic cardiovascular diseases and risk factors, the evidence is less consistent, indicating that its effectiveness may vary based on how these services are implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Telehealth to Reduce Inequalities in Cardiovascular Outcomes in Australia and New Zealand: A Critical Review. Wade, V., Stocks, N.[2017]

Cardiac rehabilitation (CR) programs significantly reduce future cardiac events and mortality, but only about 10% of eligible patients participate due to geographical barriers.

The development of virtual CR programs, utilizing technologies like the Internet and smartphones, shows promise in improving patient access and has demonstrated positive effects on clinical outcomes in small randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Lear, SA.[2019]

Telehealth interventions (THI) significantly reduce the incidence of cardiovascular disease (CVD) in patients with a history of CVD, with a relative risk reduction of 45% compared to usual care, based on a meta-analysis of 8 randomized controlled trials involving 1635 individuals.

In contrast, THI did not show a significant effect on CVD incidence in patients without a prior history of CVD, indicating that the benefits of THI may be more pronounced in those already at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of telehealth interventions on major cardiovascular outcomes: a meta-analysis of randomized controlled trials. Gu, X., Zhu, Y., Zhang, Y., et al.[2020]

In a study involving 428 Veterans with poorly controlled hypertension and/or hypercholesterolemia, a telehealth intervention led by clinical pharmacist specialists did not significantly reduce the Framingham cardiovascular disease (CVD) risk score compared to an education control group over 12 months.

However, the intervention group showed a significant decrease in total cholesterol levels at 6 months, suggesting potential benefits for those who actively engaged with the program, as only 34% of participants completed the recommended intervention calls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. Bosworth, HB., Olsen, MK., McCant, F., et al.[2020]

Telehealth cardiac rehabilitation (CR) programs significantly improve physical activity levels and medication adherence in patients with coronary heart disease (CHD), based on an umbrella review of 13 systematic reviews involving 132 primary studies across 28 countries.

These telehealth interventions do not increase the risk of mortality, adverse events, hospital readmissions, or need for revascularization, indicating they are a safe adjunct to traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Telehealth Cardiac Rehabilitation Programs on Health Outcomes of Patients With Coronary Heart Diseases: AN UMBRELLA REVIEW. Shi, W., Green, H., Sikhosana, N., et al.[2023]

A 9-week internet-based cognitive behavioral therapy (CBT) program significantly reduced depressive symptoms and increased physical activity in patients with cardiovascular disease compared to an online discussion forum, with improvements noted at the 9-week follow-up (P<0.001 for depression, P=0.02 for physical activity).

The study found a significant correlation between the reduction in depressive symptoms and the increase in physical activity, suggesting that addressing depression is crucial for enhancing physical activity levels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories and associations between depression and physical activity in patients with cardiovascular disease during participation in an internet-based cognitive behavioural therapy programme. Johansson, P., Svensson, E., Andersson, G., et al.[2021]

The Cardiac Tele-Rehabilitation (CTR) program significantly improved the quality of life for cardiac patients, with scores increasing from 111.48 to 127.92 after the program.

Participants also experienced notable reductions in anxiety and depression, with anxiety scores decreasing from 8.61 to 4.75 and depression scores from 7.27 to 2.92, indicating the program's effectiveness in enhancing mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac tele-rehabilitation in times of pandemic. Experience at the National Cardiovascular Institute INCOR in Lima-Peru]. Espinoza Pérez, J., Fernández Coronado, RO., Olórtegui Yzú, A., et al.[2023]

Cognitive Behaviour Therapy (CBT) is an effective psychological intervention for cardiovascular disease, focusing on preventing disease occurrence and addressing psychological impacts.

CBT can help modify behavioral risk factors like smoking and diet, as well as target psychological processes that contribute to heart disease, showing promise for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for cardiovascular diseases. Johnston, DW.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Telehealth interventions for the secondary prevention of coronary heart disease: A systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

The Use of Telehealth to Reduce Inequalities in Cardiovascular Outcomes in Australia and New Zealand: A Critical Review. [2017]

4. England pubmed.ncbi.nlm.nih.gov

The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. [2019]

5. China pubmed.ncbi.nlm.nih.gov

Effect of telehealth interventions on major cardiovascular outcomes: a meta-analysis of randomized controlled trials. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Telehealth Cardiac Rehabilitation Programs on Health Outcomes of Patients With Coronary Heart Diseases: AN UMBRELLA REVIEW. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Trajectories and associations between depression and physical activity in patients with cardiovascular disease during participation in an internet-based cognitive behavioural therapy programme. [2021]

9. Peru pubmed.ncbi.nlm.nih.gov

[Cardiac tele-rehabilitation in times of pandemic. Experience at the National Cardiovascular Institute INCOR in Lima-Peru]. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy for cardiovascular diseases. [2019]