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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

Must not have

Current palliative care or care through a nursing/hospice home.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Feasibility

SMS Text Acceptability

Therapist Fidelity

+2 more

Secondary study objectives

Past-Month Self-Reported Heavy Drinking Days

ReComp Pharmacy Refill Compliance Estimate for CVD medications

Systolic Blood Pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met