Positive Psychology to Improve Cardiac Health Behaviors

NCT ID: NCT01807442

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Acute Coronary Syndrome; Emotions; Patient Compliance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimal adherence

Participants receive the qualitative interview and adherence intervention.

This arm includes participants with scores of greater than or equal to 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of greater than or equal to 15 suggests optimal adherence to health behaviors.

Group Type: OTHER

Qualitative Interview and Adherence

Intervention Type: OTHER

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.

Sub-optimal adherence

Participants receive the qualitative interview and adherence intervention.

This arm includes participants with scores of less than 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of less than 15 suggests sub-optimal adherence to health behaviors.

Group Type: OTHER

Qualitative Interview and Adherence

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Medical Director of Inpatient Psychiatric Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff C Huffman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01HL113272-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011P002729

Identifier Type: -

Identifier Source: org_study_id