Acute Coronary Syndrome
Conditions
Keywords
Acute coronary syndrome, Health behavior, Mental health
Brief summary
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.
Interventions
BEHAVIORALPositive psychology intervention
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Exercise Completion | 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. |
| Ease of Exercises | 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. |
| Self-reported Psychological Impact of Exercises | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Psychological Impact of Exercises | 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: 1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism) 2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect) 3. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Psychology Positive psychology intervention | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Positive Psychology |
|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 11.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Ease of Exercises
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology | Ease of Exercises | 7.4 scores on a scale | Standard Deviation 2.1 |
Primary
Rate of Exercise Completion
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Psychology | Rate of Exercise Completion | 17 Participants |
Primary
Self-reported Psychological Impact of Exercises
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology | Self-reported Psychological Impact of Exercises | Optimism | 7.9 points | Standard Deviation 1.5 |
| Positive Psychology | Self-reported Psychological Impact of Exercises | Happiness | 8.0 points | Standard Deviation 1.6 |
Secondary
Objective Psychological Impact of Exercises
Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include: 1. Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism) 2. Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect) 3. 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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology | Objective Psychological Impact of Exercises | LOT-R | 23.5 points | Standard Deviation 4.8 |
| Positive Psychology | Objective Psychological Impact of Exercises | HADS | 13.4 points | Standard Deviation 8.9 |
| Positive Psychology | Objective Psychological Impact of Exercises | PANAS | 35.1 points | Standard Deviation 7.9 |
| Positive Psychology | Objective Psychological Impact of Exercises | HADS | 9.0 points | Standard Deviation 5.6 |
| Positive Psychology | Objective Psychological Impact of Exercises | LOT-R | 23.0 points | Standard Deviation 5.8 |
| Positive Psychology | Objective Psychological Impact of Exercises | PANAS | 38.2 points | Standard Deviation 8.6 |