This study is a single-arm, 12-week trial to test the feasibility of a PP-MI intervention for patients recently admitted following ACS. PP-MI is a novel positive psychology-based health behavior intervention that is adapted for patients hospitalized for ACS. The intervention aims to cultivate positive emotions in this vulnerable population that could provide broad and significant health benefits, and may have distinct-and more powerful-effects than simply attempting to dampen negative emotions. The primary aim is to assess whether the intervention exercises are feasible and linked with immediate boosts in positive affect upon completion. The secondary goal is to provide the research team with greater experience recruiting inpatients with an ACS, successfully completing intervention sessions, and administering psychological and medical assessments by phone.
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, a study interventionist will provide a treatment manual for the positive psychology + motivational interviewing intervention, 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 and motivational interviewing portions of the program, and will be assigned the first exercise. Participants 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 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, 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 the follow-up timepoint as an objective measure of physical activity, which they will return by mail to the study staff.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
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.
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Number of intervention sessions completed by participants
Measured by number of intervention sessions completed by participants
Time frame: 12 weeks
Change in physical activity
As measured by accelerometer
Time frame: Baseline, 12 week
Change in medication adherence
Measured by SRMA, a two-item self-report medication adherence scale measuring percentage of time patients report taking their heart medications in the past one and two weeks.
Time frame: Baseline, 12 week
Change in dietary adherence
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Time frame: Baseline, 12 week
Change in positive affect
Measured by the Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, 12 week
Change in trait optimism
Measured by the Life Orientation Test-Revised (LOT-R)
Time frame: Baseline, 12 week
Change in state optimism
Measured by the State Optimism Scale developed by Dr. Jeff Huffman
Time frame: Baseline, 12 week
Change in anxiety
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Baseline, 12 week
Change in depression
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Baseline, 12 week
Change in physical function
Measured by the Duke Activity Status Index (DASI)
Time frame: Baseline, 12 week
Change in health-related quality of life
Measured by the Short Form 12 (SF-12)
Time frame: Baseline, 12 week
Change in adherence to health behaviors
Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
Time frame: Baseline, 12 week
Change in cardiac symptoms
Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study
Time frame: Baseline, 12 week
Change in physical activity
Measured by the self-report International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 12 week
Change in perceived stress
Measured by the perceived stress scale (PSS-4) measure
Time frame: Baseline, 12 week
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