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Healthy Heart Habits

NCT04158219 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-10

Study results available
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Summary

Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.

Conditions

Interventions

BEHAVIORAL

Behavioral activation for health and depression (BA-HD)

Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes).

Sponsors & Collaborators

  • Hennepin Healthcare Research Institute

    lead OTHER

Principal Investigators

  • Andrew M Busch, PhD · Hennepin Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-02-24
Completion
2021-02-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158219 on ClinicalTrials.gov