Telehealth Cognitive Behavioral Therapy for Alcohol Abuse with Cardiovascular Risk
(ACME-TM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must be taking: Hypertension, Hyperlipidemia, Diabetes
Disqualifiers: Severe alcohol dependence, Palliative care, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
14567How 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.
158910Eligibility Criteria
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.
+4 more
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.
+4 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: ACME-TMExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Durham VA Medical Center, Durham, NCDurham, NC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Telehealth interventions for the secondary prevention of coronary heart disease: A systematic review and meta-analysis. [2023]Coronary heart disease (CHD) is a major cause of death worldwide. Cardiac rehabilitation, an evidence-based CHD secondary prevention programme, remains underutilized. Telehealth may offer an innovative solution to overcome barriers to cardiac rehabilitation attendance. We aimed to determine whether contemporary telehealth interventions can provide effective secondary prevention as an alternative or adjunct care compared with cardiac rehabilitation and/or usual care for patients with CHD.
Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis. [2022]Cardiac rehabilitation (CR) is an evidence-based recommendation for patients with coronary artery disease (CAD). However, CR is dramatically underutilized. Telehealth interventions have the potential to overcome barriers and may be an innovative model of delivering CR. This review aimed to determine the effectiveness of telehealth intervention delivered CR compared with center-based supervised CR.
The Use of Telehealth to Reduce Inequalities in Cardiovascular Outcomes in Australia and New Zealand: A Critical Review. [2017]Telehealth, the delivery of health care services at a distance using information and communications technology, is one means of redressing inequalities in cardiovascular outcomes for disadvantaged groups in Australia. This critical review argues that there is sufficient evidence to move to larger-scale implementation of telehealth for acute cardiac, acute stroke, and cardiac rehabilitation services. For cardiovascular chronic disease and risk factor management, telehealth-based services can deliver value but the evidence is less compelling, as the outcomes of these programs are variable and depend upon the context of their implementation.
The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. [2019]Cardiac rehabilitation (CR) programs are a proven therapy for patients with cardiovascular disease, reducing future cardiac events and premature mortality. However, as little as 10% of eligible patients attend these programs, with a key reason being geographical inaccessibility. In Canada, more than 90% of Canadians have Internet access, and there are approximately 31 million cell phone subscribers, with these numbers expected to continue to increase. The proliferation of these affordable communications technologies has opened up opportunities for patient communication while bridging geographic distance. This has led to the development of "virtual" CR that can be remotely conducted, reaching patients in their homes and communities. These programs have used a range of technologies such as telephone, Internet, text messaging, and smartphones. Early research has focused on acceptance of use and feasibility in pilot studies, indicating patient willingness for use. More recently, a number of small, randomized trials have been conducted indicating potential positive effect on various clinical outcomes. This narrative review highlights the evidence to date on the use of virtual CR, using a variety of affordable communications technologies from early feasibility studies to modest randomized controlled trials. Finally, lessons from previous studies are discussed to help inform the development and testing of future virtual CR. This will be important if virtual CR is to become part of standard health care.
Effect of telehealth interventions on major cardiovascular outcomes: a meta-analysis of randomized controlled trials. [2020]Telehealth interventions (THI) were associated with lower levels of cardiovascular risk factors in adults, whereas the effect of THI on cardiovascular disease (CVD) still remains controversial. A meta-analysis was conducted to summarize the evidence from randomized controlled trials (RCT) which investigated potential impact of THI on the incidence of CVD in patients with or without prior CVD.
Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. [2020]Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction.
Effectiveness of Telehealth Cardiac Rehabilitation Programs on Health Outcomes of Patients With Coronary Heart Diseases: AN UMBRELLA REVIEW. [2023]The aim of this study was to conduct an umbrella review summarizing the evidence from existing systematic reviews of telehealth cardiac rehabilitation (CR) on health outcomes of patients with coronary heart disease (CHD).
Trajectories and associations between depression and physical activity in patients with cardiovascular disease during participation in an internet-based cognitive behavioural therapy programme. [2021]There is a lack of knowledge about internet-based cognitive behavioural therapy in patients with cardiovascular disease, and its effects on depressive symptoms and physical activity.
[Cardiac tele-rehabilitation in times of pandemic. Experience at the National Cardiovascular Institute INCOR in Lima-Peru]. [2023]Cardiac Rehabilitation (CR) programs based on telehealth are an alternative in the context of a pandemic and represent an opportunity to continue in the intervention of cardiovascular diseases (CVD). The present study aims to evaluate the effect of a Cardiac Tele-Rehabilitation (CTR) program on quality of life, anxiety/depression index, exercise safety and Level Of disease awareness in patients discharged from a national referral institute in times of pandemic.
Cognitive behaviour therapy for cardiovascular diseases. [2019]Cognitive behaviour therapy (CBT) is the main empirically evaluated from of psychological therapy. When applied to cardiovascular disease it can be directed at preventing the occurrence or recurrence of disease or at altering the psychological consequences of disease. Prevention can be achieved through the modification of behavioural risk factors (e.g. smoking, diet) or by attempting to directly modify the psychological processes involved in atherogenesis and thrombogenesis. Successful applications of CBT in cardiovascular disease are described, some the remaining problems indicated and new directions for research pointed out.