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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist veterans who struggle with alcohol use and face heart disease risks, such as high blood pressure or diabetes. It combines online therapy sessions with daily text messages to reduce alcohol use and improve heart health. This approach, known as Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM), provides support through telehealth cognitive behavioral therapy. Participants must have alcohol-related issues and heart risk factors, like uncontrolled high blood pressure, and must own a phone capable of receiving text messages. The goal is to determine if these methods are user-friendly and beneficial for both veterans and their doctors. As an unphased trial, this study offers veterans the chance to explore innovative support methods that could enhance their health and well-being.

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.

What prior data suggests that this intervention is safe for alcohol misuse and cardiovascular risk?

Research shows that telehealth cognitive behavioral therapy (CBT) for alcohol misuse is generally safe. Studies have found that digital CBT can help people stop drinking without causing serious harm.

Safety information specifically about telehealth indicates that serious problems are rare. However, not all studies reported detailed information about any issues, so while problems are uncommon, they might not be fully documented.

Overall, telehealth treatments, including CBT, appear to be well-tolerated. Participants in these studies did not report major negative effects, suggesting the treatment is safe for most people, though individual experiences might differ. Discussing any concerns with the clinical team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACME-TM treatment because it combines telehealth cognitive behavioral therapy (CBT) with daily mobile health (mHealth) support to tackle both alcohol misuse and cardiovascular risk. Unlike traditional face-to-face therapy sessions and medication, this approach leverages technology to provide accessible, real-time support, making it easier for participants to integrate into their daily lives. The addition of daily text messages for a month also offers continuous engagement and motivation, which is a novel way to help reduce cardiovascular risk factors alongside alcohol use. This dual-focus and tech-driven delivery method could represent a significant advancement in treating these conditions concurrently.

What evidence suggests that this telehealth CBT is effective for alcohol misuse and cardiovascular risk?

Research has shown that online therapy, known as telehealth cognitive behavioral therapy (CBT), can effectively help people struggling with alcohol misuse. In this trial, participants will receive the ACME-TM treatment, which includes telehealth CBT sessions focused on reducing alcohol misuse. Studies have found that telehealth CBT makes it easier for people to access the help they need and has shown promise in reducing alcohol consumption. Combining telehealth with text messages can also encourage healthier habits, which may help manage heart health risks. This method might particularly benefit people with high blood pressure, as reducing alcohol intake can help lower blood pressure. While research is ongoing, early results suggest that this approach could reduce alcohol misuse and improve heart health. ^{1 6 7 8 9}

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

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]

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]

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]

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]

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04838457

Telehealth Treatment of Veterans With Alcohol Misuse at ... The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31209579/

Telehealth Treatment for Alcohol Misuse Evidence for telehealth cognitive behavioral therapy (CBT) is preliminary but suggests it is efficacious and increased access to treatment.

3. research.va.gov research.va.gov/about/funded_research/projects-FY2024.cfm

FY 2024 VA-Funded Projects If you are a Veteran in crisis or concerned about one, connect with our caring, qualified responders for confidential help.

4. researchgate.net researchgate.net/figure/Integration-of-telehealth-approaches-across-the-alcohol-misuse-intervention-process_fig1_333827224

Integration of telehealth approaches across the alcohol ... Purpose of Review Telehealth interventions for alcohol misuse may be especially impactful in hypertensive populations because of the increased blood ...

5. telehealth.hhs.gov telehealth.hhs.gov/research-articles

Research Articles and Papers This research examined the use of telehealth for behavioral health services at Critical Access Hospitals (CAHs). Findings indicate that patient ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03230006?term=todd%20farchione&rank=1

Transdiagnostic CBT for Comorbid Alcohol Use and ... In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11428014/

A Digital Cognitive Behavioral Therapy Program for Adults ... Participants assigned to digital CBT showed substantial increases in rates of abstinence from alcohol during a relatively brief treatment period ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1337898/full

Virtual reality-assisted cognitive behavioral therapy for ... We demonstrated VR-CBT to be a feasible intervention for patients with AUD which supports continued investigations in a larger randomized clinical trial.

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK586283/

Evidence Brief: Safety and Effectiveness of Telehealth ... - NCBI Serious harms associated with telehealth delivery appear to be rare, but adverse events were not consistently reported across studies. Only 2 studies examined ...