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Completed

NCT Number: NCT02004158

Positive Psychology to Improve Healthy Behaviors After an Acute Coronary Syndrome

In this proof-of-concept study, the investigators will assess the ease and usefulness of a positive psychology program in patients with acute coronary syndrome and less-than-optimal adherence to health behaviors. The investigators believe that positive psychology (a field that studies boosting positive emotions rather than simply reducing negative emotions) will help this cardiac population to be more healthy. The investigators want to determine whether this positive psychology program has the potential to be an adjunctive treatment for cardiac populations.

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Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Health Behavior Heart Diseases Myocardial Ischemia Personal Satisfaction Psychological Well-Being Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients admitted to one of three cardiac inpatient units at Massachusetts General Hospital.
  • Primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina).
  • Less-than-optimal adherence to health behaviors. This will be defined as a mean score of less than 15 on the Medical Outcomes Study Specific Adherence Scale (scores range from 3-18, with higher scores indicating better adherence).

Exclusion criteria

  • Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
  • Patients not prescribed aspirin at discharge.
  • Inability to communicate in English.
  • Inability to participate in physical activity.

Treatment and study plan

Positive Psychology intervention

Behavioral

Primary outcomes

  1. Rate of Exercise Completion

    Time frame: 8 weeks

    Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.

  2. Ease of Exercises

    Time frame: 8 weeks

    Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.

  3. Self-reported Psychological Impact of Exercises

    Time frame: 8 weeks

    Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.

Secondary outcomes

  1. Objective Psychological Impact of Exercises

    Time frame: 8 weeks

    Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:

    • Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)
    • Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)
    • Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).

    Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Study of a Positive Psychology Program to Improve Healthy Behaviors After an Acute Coronary Syndrome: Proof of Concept Study

Acronym: PEACE II

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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