Healthy Heart Habits

Depression Clinical Trial

— H^3  

Official title:

Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158219
• Other study ID #: 1R03HL136540
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 15, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: March 2022
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Depression
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
United States	Hennepin Healthcare	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment Engagement Measured by Sessions Attended	Throughout the study we will measure engagement by tracking attendance of treatment sessions.	At 12 weeks
Secondary	Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments	Study retention will be tracked by measuring the number of participants who complete the follow-up assessments	At 12 weeks
Secondary	Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)	Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms.	At 12 weeks
Secondary	Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)	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.	At 12 weeks
Secondary	Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)	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. Items are rated on a 1-6 scale. Because not all items will be relevant to all participants, the average score across the relevant items for each participant will be presented. Higher scores indicating greater adherence to healthcare provider recommendations.	At 12 weeks