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Behavioral Intervention

Telehealth Cognitive Behavioral Therapy for Alcohol Abuse with Cardiovascular Risk (ACME-TM Trial)

N/A

Recruiting

Led By Daniel Blalock, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-baseline

Awards & highlights

ACME-TM Trial Summary

This trial is testing a cognitive-behavioral intervention for Veterans with comorbid alcohol misuse and cardiovascular disease risk. The intervention includes telehealth CBT for alcohol misuse, tailored and timely text messages, and a telehealth coaching call. The primary hypotheses are that the intervention will be feasible, acceptable, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves behavioral therapy rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort discussing personal habits like drinking during the counseling sessions.

ACME-TM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with high blood pressure, high cholesterol, or diabetes for over a year.

ACME-TM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment Feasibility

SMS Text Acceptability

Therapist Fidelity

+2 more

Secondary outcome measures

Past-Month Self-Reported Heavy Drinking Days

ReComp Pharmacy Refill Compliance Estimate for CVD medications

Systolic Blood Pressure

ACME-TM Trial Design

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,307,321 Total Patients Enrolled

2 Trials studying Alcohol Abuse

204 Patients Enrolled for Alcohol Abuse

Daniel Blalock, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Media Library

Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04838457 — N/A

Alcohol Abuse Research Study Groups: ACME-TM

Alcohol Abuse Clinical Trial 2023: Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) Highlights & Side Effects. Trial Name: NCT04838457 — N/A

Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838457 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participators in this research trial?

"Affirmative. Clinicaltrials.gov has revealed that this study began enrolling participants on December 1st 2021 and is still actively recruiting today, after its latest update from the same day in 2022. Currently, 40 patients are needed for enrolment at a single location."

Answered by AI

Is enrollment still available for this medical research project?

"Affirmative. According to materials on clinicaltrials.gov, this medical trial began accepting applications on December 1st 2021 and is still actively looking for candidates. The study seeks a total of 40 patients from one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease

2021. "Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838457.

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