Positive Psychology to Improve Cardiac Health Behaviors (PEACE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01807442
First received: March 4, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Emotions
Patient Compliance
Other: Qualitative Interview and Adherence

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Deficits in positive affect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Barriers to health behaviors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Changes in positive affect [ Time Frame: Change from baseline positive affect at 12 weeks ] [ Designated as safety issue: No ]

    Qualitative data:

    The investigators will compare information from the 2 qualitative interviews to learn about participants' changes in positive affect.



Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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.

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807442

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeff C. Huffman, MD, Medical Director of Inpatient Psychiatric Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01807442     History of Changes
Other Study ID Numbers: 2011P002729, 1R01HL113272-01A1
Study First Received: March 4, 2013
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Acute Coronary Syndrome
Positive Psychology
Adherence to Health Behaviors

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014