ACS - Acute Coronary Syndrome
Conditions
Brief summary
This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes. The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
Detailed description
The initial study visit will occur in-person two weeks after discharge from the hospital. Participants will meet with a member of the study staff (the study trainer) and complete self-report questionnaires assessing health behavior adherence and mental and physical health. Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions. A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise. If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise. Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise. Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant. Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment. Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures. Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
Interventions
For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
BEHAVIORALMotivational Interviewing Health Education
Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating study staff will be aware of the patient's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
Intervention model description
Randomized, single-blinded, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units * Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team) * Age 18 or older * Suboptimal adherence on MOS-SAS: Score \< 15 OR Score = 15 with physical activity \< 6
Exclusion criteria
* Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies. * Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator. * Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping. * Inability to communicate in English. * Inability to participate in physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the PP-MI Based Health Behavior Intervention | 24 weeks | Feasibility will be measured by examining the number of completed exercises. |
| Acceptability of the PP-MI Exercises: Utility Score | Weeks 1-12 | Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises. |
| Acceptability of the PP-MI Exercises: Ease Score | Weeks 1-12 | Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive Affect | Change in score from Baseline to 12 weeks, 24 weeks | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect. |
| Change in Trait Optimism | Change in score from baseline to 12 week, 24 week | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism. |
| Change in State Optimism | Change of score from Baseline to 12 weeks, 24 weeks | Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. |
| Changes in HADS-A Scores | Change in score from Baseline to 12 week, 24 week | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety. |
| Change in HADS-D Scores | Change in score from Baseline to 12 week, 24 week | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression). |
| Change in Physical Function | Change of score from Baseline to 12 week, 24 week | Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity. |
| Minutes of Moderate to Vigorous Physical Activity (Actigraph) | MVPA at 12 weeks and 24 weeks | ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity. |
| Change in SF-12 Scores (Mental) | Change of score from baseline to 12 and 24 weeks. | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. |
| Change in Adherence to Health Behaviors | Change of score from Baseline to 12 week, 24 week | Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors. |
| Change in Cardiac Symptoms | Change of score from Baseline to 12 week, 24 week | Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms. |
| Change in Physical Activity | Change of score from Baseline to 12 week, 24 week | Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. |
| Change in Perceived Stress | Change of score from Baseline to 12 week, 24 week | Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress. |
| Change in SF-12 Scores (Physical) | Change of score from Baseline to 12 week, 24 week | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. |
| Change in Medication Adherence | Change in score from Baseline to 12 weeks, 24 weeks | Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence. |
| Change in Dietary Adherence | Change in score from Baseline to 12 weeks, 24 weeks | Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence. |
Countries
United States
Participant flow
Pre-assignment details
69 participants enrolled in the study but 22 either withdrew their consent or failed to attend their first in-person visit before randomization. Forty-seven individuals were randomized to a treatment condition.
Participants by arm
| Arm | Count |
|---|---|
| Positive Psychology + Motivational Interviewing Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting. | 24 |
| Motivational Interviewing Health Education Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction). | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | Terminated due to cognitive problem | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Positive Psychology + Motivational Interviewing | Motivational Interviewing Health Education | Total |
|---|---|---|---|
| Adherence to Health Behaviors | 9.9 score on a scale STANDARD_DEVIATION 2.7 | 11.1 score on a scale STANDARD_DEVIATION 2.6 | 10.5 score on a scale STANDARD_DEVIATION 2.7 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 12 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 11 Participants | 29 Participants |
| Cardiac Symptoms | 9.2 score on a scale STANDARD_DEVIATION 5.2 | 8.5 score on a scale STANDARD_DEVIATION 5.3 | 8.9 score on a scale STANDARD_DEVIATION 5.2 |
| Dietary Adherence | 54.8 score on a scale STANDARD_DEVIATION 27.4 | 55.4 score on a scale STANDARD_DEVIATION 32.2 | 55.1 score on a scale STANDARD_DEVIATION 29.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HADS-A Score | 5.5 score on a scale STANDARD_DEVIATION 3.9 | 5.2 score on a scale STANDARD_DEVIATION 4 | 5.3 score on a scale STANDARD_DEVIATION 3.9 |
| HADS-D Score | 4.0 score on a scale STANDARD_DEVIATION 2.9 | 3.5 score on a scale STANDARD_DEVIATION 2.4 | 3.7 score on a scale STANDARD_DEVIATION 2.7 |
| Medication Adherence | 95 percentage of time STANDARD_DEVIATION 18 | 98 percentage of time STANDARD_DEVIATION 4 | 97 percentage of time STANDARD_DEVIATION 13 |
| Perceived Stress | 5.7 score on a scale STANDARD_DEVIATION 3.4 | 5.7 score on a scale STANDARD_DEVIATION 2.7 | 5.7 score on a scale STANDARD_DEVIATION 3 |
| Physical Activity | 2439.7 MET-minutes per week STANDARD_DEVIATION 5067.6 | 1809.8 MET-minutes per week STANDARD_DEVIATION 2266.8 | 2131.5 MET-minutes per week STANDARD_DEVIATION 3924.2 |
| Physical Function | 37.3 score on a scale STANDARD_DEVIATION 13.3 | 43.2 score on a scale STANDARD_DEVIATION 13.9 | 40.2 score on a scale STANDARD_DEVIATION 13.8 |
| Positive Affect | 28.5 score on a scale STANDARD_DEVIATION 7.2 | 33.3 score on a scale STANDARD_DEVIATION 6.3 | 30.9 score on a scale STANDARD_DEVIATION 7.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 19 Participants | 43 Participants |
| Region of Enrollment United States | 24 participants | 23 participants | 47 participants |
| Sex: Female, Male Female | 17 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Male | 7 Participants | 19 Participants | 26 Participants |
| SF-12 Scores (Mental) | 46.9 score on a scale STANDARD_DEVIATION 8.9 | 49.3 score on a scale STANDARD_DEVIATION 8 | 48.1 score on a scale STANDARD_DEVIATION 8.5 |
| SF-12 Scores (Physical) | 37.0 score on a scale STANDARD_DEVIATION 7 | 40.0 score on a scale STANDARD_DEVIATION 9 | 38.3 score on a scale STANDARD_DEVIATION 8 |
| State Optimisim | 25.8 score on a scale STANDARD_DEVIATION 6.9 | 28.0 score on a scale STANDARD_DEVIATION 5.4 | 26.9 score on a scale STANDARD_DEVIATION 6.2 |
| Trait Optimism | 16.1 score on a scale STANDARD_DEVIATION 5.7 | 16.5 score on a scale STANDARD_DEVIATION 4.6 | 16.3 score on a scale STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 7 / 24 | 6 / 23 |
| serious Total, serious adverse events | 11 / 24 | 11 / 23 |
Outcome results
Primary
Acceptability of the PP-MI Exercises: Ease Score
Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Time frame: Weeks 1-12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Acceptability of the PP-MI Exercises: Ease Score | Ease of the PP component | 8.3 units on a scale | Standard Deviation 2.3 |
| Positive Psychology + Motivational Interviewing | Acceptability of the PP-MI Exercises: Ease Score | Ease of the MI component | 8.1 units on a scale | Standard Deviation 2.4 |
Primary
Acceptability of the PP-MI Exercises: Utility Score
Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Time frame: Weeks 1-12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Acceptability of the PP-MI Exercises: Utility Score | Utility of the PP component | 8.0 units on a scale | Standard Deviation 2.3 |
| Positive Psychology + Motivational Interviewing | Acceptability of the PP-MI Exercises: Utility Score | Utility of the MI component | 8.2 units on a scale | Standard Deviation 2.2 |
Primary
Feasibility of the PP-MI Based Health Behavior Intervention
Feasibility will be measured by examining the number of completed exercises.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Feasibility of the PP-MI Based Health Behavior Intervention | 10.0 exercises completed | Standard Deviation 3.9 |
Secondary
Change in Adherence to Health Behaviors
Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Adherence to Health Behaviors | 12 weeks | 4.9 score on a scale | Standard Deviation 3.1 |
| Positive Psychology + Motivational Interviewing | Change in Adherence to Health Behaviors | 24 weeks | 4.4 score on a scale | Standard Deviation 2.9 |
| Motivational Interviewing Health Education | Change in Adherence to Health Behaviors | 12 weeks | 3.5 score on a scale | Standard Deviation 2.7 |
| Motivational Interviewing Health Education | Change in Adherence to Health Behaviors | 24 weeks | 3.3 score on a scale | Standard Deviation 3.4 |
Secondary
Change in Cardiac Symptoms
Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Not all participants provided data at all follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Cardiac Symptoms | 12 weeks | -6.6 score on a scale | Standard Deviation 3.7 |
| Positive Psychology + Motivational Interviewing | Change in Cardiac Symptoms | 24 weeks | -6.6 score on a scale | Standard Deviation 4.6 |
| Motivational Interviewing Health Education | Change in Cardiac Symptoms | 12 weeks | -4.8 score on a scale | Standard Deviation 4.4 |
| Motivational Interviewing Health Education | Change in Cardiac Symptoms | 24 weeks | -5.1 score on a scale | Standard Deviation 4.3 |
Secondary
Change in Dietary Adherence
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence.
Time frame: Change in score from Baseline to 12 weeks, 24 weeks
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone who provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Dietary Adherence | 12 weeks | -2.8 score on a scale | Standard Deviation 31.2 |
| Positive Psychology + Motivational Interviewing | Change in Dietary Adherence | 24 weeks | 2.1 score on a scale | Standard Deviation 33.8 |
| Motivational Interviewing Health Education | Change in Dietary Adherence | 12 weeks | -17.6 score on a scale | Standard Deviation 21.5 |
| Motivational Interviewing Health Education | Change in Dietary Adherence | 24 weeks | -7.7 score on a scale | Standard Deviation 25.6 |
Secondary
Change in HADS-D Scores
The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).
Time frame: Change in score from Baseline to 12 week, 24 week
Population: We will use a random effects regression model with a random intercept for each participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in HADS-D Scores | 12 weeks | -1.8 score on a scale | Standard Deviation 2.8 |
| Positive Psychology + Motivational Interviewing | Change in HADS-D Scores | 24 weeks | -1.5 score on a scale | Standard Deviation 3.3 |
| Motivational Interviewing Health Education | Change in HADS-D Scores | 12 weeks | .5 score on a scale | Standard Deviation 2.5 |
| Motivational Interviewing Health Education | Change in HADS-D Scores | 24 weeks | -0.8 score on a scale | Standard Deviation 2.2 |
Secondary
Change in Medication Adherence
Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence.
Time frame: Change in score from Baseline to 12 weeks, 24 weeks
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Medication Adherence | 12 weeks | 5 percentage of time | Standard Deviation 2.2 |
| Positive Psychology + Motivational Interviewing | Change in Medication Adherence | 24 weeks | 0 percentage of time | Standard Deviation 0 |
| Motivational Interviewing Health Education | Change in Medication Adherence | 12 weeks | 5 percentage of time | Standard Deviation 2.2 |
| Motivational Interviewing Health Education | Change in Medication Adherence | 24 weeks | -6 percentage of time | Standard Deviation 5.4 |
Secondary
Change in Perceived Stress
Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Not all participants provided data at all follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Perceived Stress | 12 weeks | -2.8 score on a scale | Standard Deviation 3 |
| Positive Psychology + Motivational Interviewing | Change in Perceived Stress | 24 weeks | -2.3 score on a scale | Standard Deviation 3 |
| Motivational Interviewing Health Education | Change in Perceived Stress | 12 weeks | -1.4 score on a scale | Standard Deviation 3.1 |
| Motivational Interviewing Health Education | Change in Perceived Stress | 24 weeks | -2.5 score on a scale | Standard Deviation 2.9 |
Secondary
Change in Physical Activity
Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Physical Activity | 12 weeks | 649.5 MET-minutes per week | Standard Deviation 1857.1 |
| Positive Psychology + Motivational Interviewing | Change in Physical Activity | 24 weeks | -359.4 MET-minutes per week | Standard Deviation 1671.7 |
| Motivational Interviewing Health Education | Change in Physical Activity | 12 weeks | 159.9 MET-minutes per week | Standard Deviation 4244.6 |
| Motivational Interviewing Health Education | Change in Physical Activity | 24 weeks | -171.1 MET-minutes per week | Standard Deviation 2014 |
Secondary
Change in Physical Function
Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Physical Function | 12 weeks | 9.7 score on a scale | Standard Error 11.7 |
| Positive Psychology + Motivational Interviewing | Change in Physical Function | 24 weeks | 14.1 score on a scale | Standard Error 13 |
| Motivational Interviewing Health Education | Change in Physical Function | 12 weeks | 4.4 score on a scale | Standard Error 13.3 |
| Motivational Interviewing Health Education | Change in Physical Function | 24 weeks | 4.9 score on a scale | Standard Error 10.8 |
Secondary
Change in Positive Affect
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.
Time frame: Change in score from Baseline to 12 weeks, 24 weeks
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Positive Affect | 12 weeks | 8.8 score on a scale | Standard Deviation 6 |
| Positive Psychology + Motivational Interviewing | Change in Positive Affect | 24 weeks | 9.5 score on a scale | Standard Deviation 6.8 |
| Motivational Interviewing Health Education | Change in Positive Affect | 12 weeks | 4.9 score on a scale | Standard Deviation 6.5 |
| Motivational Interviewing Health Education | Change in Positive Affect | 24 weeks | 2.2 score on a scale | Standard Deviation 6.6 |
Secondary
Change in SF-12 Scores (Mental)
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
Time frame: Change of score from baseline to 12 and 24 weeks.
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in SF-12 Scores (Mental) | 12 week | 8.8 score on a scale | Standard Deviation 8.7 |
| Positive Psychology + Motivational Interviewing | Change in SF-12 Scores (Mental) | 24 week | 6.3 score on a scale | Standard Deviation 7.9 |
| Motivational Interviewing Health Education | Change in SF-12 Scores (Mental) | 12 week | 1.3 score on a scale | Standard Deviation 5.8 |
| Motivational Interviewing Health Education | Change in SF-12 Scores (Mental) | 24 week | 2.6 score on a scale | Standard Deviation 4.8 |
Secondary
Change in SF-12 Scores (Physical)
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.
Time frame: Change of score from Baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in SF-12 Scores (Physical) | 12 weeks | 8.0 score on a scale | Standard Deviation 8 |
| Positive Psychology + Motivational Interviewing | Change in SF-12 Scores (Physical) | 24 weeks | 12.3 score on a scale | Standard Deviation 7.4 |
| Motivational Interviewing Health Education | Change in SF-12 Scores (Physical) | 12 weeks | 7.2 score on a scale | Standard Deviation 8.3 |
| Motivational Interviewing Health Education | Change in SF-12 Scores (Physical) | 24 weeks | 6.8 score on a scale | Standard Deviation 7.4 |
Secondary
Change in State Optimism
Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Time frame: Change of score from Baseline to 12 weeks, 24 weeks
Population: Not all participants provided data at all follow-up points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in State Optimism | Change in SOM at 24 weeks | 6.0 score on a scale | Standard Deviation 7.1 |
| Positive Psychology + Motivational Interviewing | Change in State Optimism | Change in SOM at 12 weeks | 5.3 score on a scale | Standard Deviation 6.5 |
| Motivational Interviewing Health Education | Change in State Optimism | Change in SOM at 12 weeks | -.1 score on a scale | Standard Deviation 6.8 |
| Motivational Interviewing Health Education | Change in State Optimism | Change in SOM at 24 weeks | .6 score on a scale | Standard Deviation 4.6 |
Secondary
Change in Trait Optimism
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism.
Time frame: Change in score from baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Trait Optimism | 12 weeks | 2.2 score on a scale | Standard Deviation 3.8 |
| Positive Psychology + Motivational Interviewing | Change in Trait Optimism | 24 weeks | 1.7 score on a scale | Standard Deviation 5.9 |
| Motivational Interviewing Health Education | Change in Trait Optimism | 12 weeks | 2.0 score on a scale | Standard Deviation 5.3 |
| Motivational Interviewing Health Education | Change in Trait Optimism | 24 weeks | 2.8 score on a scale | Standard Deviation 3.8 |
Secondary
Changes in HADS-A Scores
The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety.
Time frame: Change in score from Baseline to 12 week, 24 week
Population: Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Changes in HADS-A Scores | 12 weeks | -2.8 score on a scale | Standard Deviation 3.3 |
| Positive Psychology + Motivational Interviewing | Changes in HADS-A Scores | 24 weeks | -2.3 score on a scale | Standard Deviation 3.8 |
| Motivational Interviewing Health Education | Changes in HADS-A Scores | 12 weeks | -1.3 score on a scale | Standard Deviation 2.8 |
| Motivational Interviewing Health Education | Changes in HADS-A Scores | 24 weeks | -1.9 score on a scale | Standard Deviation 2 |
Secondary
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
Time frame: MVPA at 12 weeks and 24 weeks
Population: Not everyone provided follow-up data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Minutes of Moderate to Vigorous Physical Activity (Actigraph) | MVPA at 12-week | 33.0 minutes/day | Standard Deviation 19 |
| Positive Psychology + Motivational Interviewing | Minutes of Moderate to Vigorous Physical Activity (Actigraph) | MVPA at 24-week | 34.6 minutes/day | Standard Deviation 22.9 |
| Motivational Interviewing Health Education | Minutes of Moderate to Vigorous Physical Activity (Actigraph) | MVPA at 12-week | 23.2 minutes/day | Standard Deviation 26.2 |
| Motivational Interviewing Health Education | Minutes of Moderate to Vigorous Physical Activity (Actigraph) | MVPA at 24-week | 18.1 minutes/day | Standard Deviation 11.9 |