Healthy Heart Habits

NCT04158219 | Completed Phase 1 Results

• 1 other identifier: 1R03HL136540
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Acute Coronary Syndrome; Depression

Keywords

Behavioral randomized control trial; Behavioral activation; Multiple health behavior change; Integrated care

Outcome Measures

Primary Outcomes (2)

• Acceptability Measured by the Client Satisfaction Questionnaire

  This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction.

  At 12 weeks

• Treatment Engagement Measured by Sessions Attended

  Throughout the study we will measure engagement by tracking attendance of treatment sessions.

  At 12 weeks

Secondary Outcomes (4)

• Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments

  At 12 weeks

• Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)

  At 12 weeks

• Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)

  At 12 weeks

• Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)

  At 12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Behavioral activation for health and depression (BA-HD)

Behavioral: Behavioral activation for health and depression (BA-HD)

Interventions

Behavioral activation for health and depression (BA-HD) BEHAVIORAL

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).

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Gathright EC, Vickery KD, Ayenew W, Whited MC, Adkins-Hempel M, Chrastek M, Carter JK, Rosen RK, Wu WC, Busch AM. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome. PLoS One. 2022 Feb 3;17(2):e0261490. doi: 10.1371/journal.pone.0261490. eCollection 2022.

  PMID: 35113860 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Depression

Interventions

Health

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Results Point of Contact

• Title: Dr. Andrew Busch
• Organization: Hennepin Healthcare

andrew.busch@hcmed.org

6128736681

Study Officials

• Andrew M Busch, PhD

  Hennepin Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Clinical Psychologist, Associate Professor

Model Details: Twenty subjects will be given the intervention according to the treatment manual.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 15, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)