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Healthy Heart Habits (H^3)

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ClinicalTrials.gov Identifier: NCT04158219
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Busch, Hennepin Healthcare Research Institute

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Depression Behavioral: Behavioral activation for health and depression (BA-HD) Phase 1 Phase 2

Detailed Description:
Depression predicts high rates of morbidity/mortality among acute coronary syndrome (ACS) patients. Part of this relationship is explained by a poor profile of behavioral risk factors (i.e., smoking,physical activity, medication adherence, diet). An integrated treatment targeting both depressed mood and multiple behavioral risk factors could be highly effective in reducing post-ACS mortality. Behavioral Activation for depression may be an ideal counseling treatment for this since it has recently shown promise for facilitating behavioral risk factor changes in ACS patients with depression (K23HL107391). The current study adapts this manual targeting post-ACS depressed mood and smoking cessation to target depression and multiple behavioral risk factors post-ACS. This study will be an open trial (N=20) to test the feasibility and acceptability of our procedures and obtain initial indications of efficacy. This study hypothesizes that 1) the BA-HD manual and study procedures will be feasible and acceptable to post-ACS patients with depressed mood as measured by self-report, recruitment/retention rate, and post- treatment qualitative interviews and 2) that participants will experience clinically significant improvements in depressed mood and behavioral risk factor profile. The long-term goal of this research is to improve long-term survival rates following ACS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Twenty subjects will be given the intervention according to the treatment manual.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Behavioral activation for health and depression (BA-HD)
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).




Primary Outcome Measures :
  1. Acceptability measured by the Client Satisfaction Questionnaire [ Time Frame: At 12 weeks ]
    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.

  2. Treatment engagement measured by number of sessions attended [ Time Frame: At 12 weeks ]
    Throughout the study we will measure engagement by tracking attendance of treatment sessions.


Secondary Outcome Measures :
  1. Study retention measured by percentage completion of assessments [ Time Frame: At 12 weeks ]
    Study retention will be tracked by measuring the percentage of participants who complete follow-up assessments.

  2. Depression symptoms as measured by PHQ-9 (Patient Health Quetionnaire-9) [ Time Frame: At 12 weeks ]
    Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms.

  3. Depression symptoms as measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised) [ Time Frame: At 12 weeks ]
    Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale 10-item. Score range is 0-30 with higher scores indicating higher depression symptoms.

  4. Composite behavioral risk factor adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire) [ Time Frame: At 12 weeks ]
    The Medical Outcomes Study Patient Adherence Questionnaire will be used to assess adherence to behavior change goals.10 items related to cardiac health will be scored, score range is 10-60 with higher scores indicating greater adherence to healthcare provider recommendations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158219


Contacts
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Contact: Andrew M Busch, PhD 612-873-6681 Andrew.Busch@hcmed.org
Contact: Michelle L Chrastek, MPH 612-873-5364 Michelle.Chrastek@hcmed.org

Locations
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United States, Minnesota
Hennepin Healthcare Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Michelle L Chrastek, MPH    612-873-5364    Michelle.chrastek@hcmed.org   
Sub-Investigator: Katherine D Vickery, MD, MSc         
Sponsors and Collaborators
Hennepin Healthcare Research Institute
Investigators
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Principal Investigator: Andrew M Busch, PhD Hennepin Healthcare
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Responsible Party: Andrew Busch, Sr. Clinical Psychologist, Associate Professor, Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT04158219    
Other Study ID Numbers: 1R03HL136540 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Busch, Hennepin Healthcare Research Institute:
Behavioral randomized control trial
Behavioral activation
Multiple health behavior change
Integrated care
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Depression
Disease
Pathologic Processes
Behavioral Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases