Phase 2 N=8 Treatment

Healthy Heart Habits

Acute Coronary Syndrome · Depression

Bottom Line

View on ClinicalTrials.gov: NCT04158219 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Acceptability Measured by the Client Satisfaction Questionnaire — 30.57 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Behavioral activation for health and depression (BA-HD) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hennepin Healthcare Research Institute
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Acceptability Measured by the Client Satisfaction Questionnaire	30.57	—
PRIMARY Treatment Engagement Measured by Sessions Attended	8.65	—
SECONDARY Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments	7	—
SECONDARY Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)	8.29; 4.86	—
SECONDARY Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)	11.43; 8.57	—
SECONDARY Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)	3.75; 4.53	—

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.

Eligibility Criteria

Inclusion criteria

ACS diagnosis (diagnosis of unstable angina, ST and non-ST elevation myocardial infarction) documented in medical record in the preceding 2-12 months
Current diagnosis of depression documented in medical record, OR clinically administered PHQ-9 score of 10 or greater documented in the medical record in the preceding 12 months, OR CES-D score greater than or equal to 10
current non-adherence to 1 or more of 4 more behavioral risk factors
willing to make immediate changes to one or more of the relevant behavioral risk factors
age of 18-75
lives within 1.5 hours of Hennepin Healthcare
fluent in English.

Exclusion criteria

Limited mental competency (as indicated in medical chart)
presence of current exacerbation of psychosis/serious mental illness or suicidality
in hospice care
currently attending regular counseling targeting depression or any health behavior change
currently attending a cardiac rehabilitation program (those excluded for being in rehabilitation will be re-contacted after completion)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04158219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.