Clinical trial NCT01807442: Positive Psychology to Improve Cardiac Health Behaviors
Official title: Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Emotions
Patient Compliance
Keywords: Acute Coronary Syndrome
Positive Psychology
Adherence to Health Behaviors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Deficits in positive affect
timeFrame: 12 weeks
measure: Barriers to health behaviors
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in positive affect
timeFrame: Change from baseline positive affect at 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References: