Positive Psychology to Improve Cardiac Health Behaviors

Acute Coronary Syndrome Clinical Trial

— PEACE  

Official title:

Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807442
• Other study ID #: 2011P002729
• Secondary ID: 1R01HL113272-01A
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: September 15, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to understand peoples' positive emotions, like how optimistic or grateful they feel, after they have had a heart problem. The investigators want to determine whether positive emotions affect peoples' ability to follow recommendations, like following a healthy diet, exercising, and taking medication.

Description:

The investigators aim to develop a novel positive psychology intervention that is adapted for patients hospitalized for an acute coronary syndrome (ACS). A treatment cultivating positive emotions in this vulnerable population could provide broad and significant health benefits, and may have distinct—and more powerful—effects than simply attempting to dampen negative emotions.

In this study, the investigators will use mixed methods (qualitative and quantitative) to take the first step towards developing such a treatment, with a major focus on the qualitative aspects of the patient assessments/interviews.

In this project, the investigators hope to do the following:

1. Identify, through qualitative research, deficits in positive emotional and cognitive states prior to, during, and after cardiac admission: What positive emotions are lacking in hospitalized ACS patients?

2. Explore strategies to enhance positive emotional and cognitive states in ACS patients.

3. Identify links between these positive states and health behavior (diet, physical activity, and medication).

4. Identify other barriers to compliance with health behaviors. What other factors adversely influence compliance with health behaviors in this population?

5. Use quantitative measures of positive affect to ensure that the investigators are adequately capturing information about optimism and other positive states

6. Develop a preliminary positive psychology-based intervention using the above information

7. Explore the feasibility of using methods to objectively measure aspirin adherence and physical activity in this population.

To accomplish these goals, the investigators will interview 30 ACS patients during admission to the inpatient cardiac unit and 12 weeks after discharge. The investigators will identify 15 patients who demonstrate suboptimal adherence as reported by the Medical Outcomes Study Specific Adherence Scale (MOS-SAS) and 15 patients who demonstrate good adherence to health-related behaviors.

For these interviews, the investigators will first ask about positive emotional states that patients have experienced. the investigators will then inquire about potential ideas for increasing these positive emotional states by asking patients what has worked for them in the past and what they have noticed seems to work for others. The investigators will also describe some positive psychology exercises to the patients and ask whether they think those exercises would be effective at increasing positive emotional states. Next, the investigators will ask about health behaviors in which the patient has engaged. The investigators will explore the relationship between these behaviors and positive emotional states. Finally, the investigators will explore with patients some barriers to completing health behaviors and solicit suggestions for overcoming or mitigating these barriers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to Massachusetts General Hospital cardiac floors (Ellison 9, 10, 11)

• Age 18 or older

• Admitted with myocardial infarction or unstable angina

• Score of less than 15 --OR-- greater than or equal to 15 on the adherence scale

• Ability to read and write in English

Exclusion Criteria:

• Cognitive deficits as assessed by a 6-item screen

• Medical conditions that prevent interviewing or are likely to lead to death within 6 months

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Emotions
• Patient Compliance

Intervention

Other:
• Qualitative Interview and Adherence
All participants receive the same intervention. The intervention involves two qualitative interviews per participant. The first interview occurs in the hospital, and the second interview occurs at 12 weeks. Participants also receive a pill bottle that tracks when they take their aspirin. They will also receive a step counter to use for two weeks at the end of the study.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deficits in positive affect	Qualitative data: The investigators will extract information from 2 quantitative interviews to learn about participants' deficits in positive affect.; Quantitative data: Life Orientation Test-Revised, Positive And Negative Affect Scale, Hospital Anxiety and Depression Scale.	12 weeks	No
Primary	Barriers to health behaviors	Qualitative data: The investigators will extract information from 2 qualitative interviews to learn about participants' barriers to completing health behaviors.; Quantitative data: Participants will receive a pill bottle that tracks when they take their aspirin. Participants will also receive a step counter to wear for two weeks.	12 weeks	No
Secondary	Changes in positive affect	Qualitative data: The investigators will compare information from the 2 qualitative interviews to learn about participants' changes in positive affect.	Change from baseline positive affect at 12 weeks	No