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In-person recruitment deemed not feasible due to COVID
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intervention sessions completed by participants | Measured by number of intervention sessions completed by participants | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | As measured by accelerometer | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Moskowitz, PhD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11315248 | Background | Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218. | |
| 3397865 | Background | Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000080032 | Psychology, Positive |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
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|
| Baseline, 12 week |
| Change in dietary adherence | Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. | Baseline, 12 week |
| Change in positive affect | Measured by the Positive and Negative Affect Schedule (PANAS) | Baseline, 12 week |
| Change in trait optimism | Measured by the Life Orientation Test-Revised (LOT-R) | Baseline, 12 week |
| Change in state optimism | Measured by the State Optimism Scale developed by Dr. Jeff Huffman | Baseline, 12 week |
| Change in anxiety | Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) | Baseline, 12 week |
| Change in depression | Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) | Baseline, 12 week |
| Change in physical function | Measured by the Duke Activity Status Index (DASI) | Baseline, 12 week |
| Change in health-related quality of life | Measured by the Short Form 12 (SF-12) | Baseline, 12 week |
| Change in adherence to health behaviors | Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS) | Baseline, 12 week |
| Change in cardiac symptoms | Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study | Baseline, 12 week |
| Change in physical activity | Measured by the self-report International Physical Activity Questionnaire (IPAQ) | Baseline, 12 week |
| Change in perceived stress | Measured by the perceived stress scale (PSS-4) measure | Baseline, 12 week |
| 21115758 | Background | Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990. |
| 22018588 | Background | Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. |
| 17577653 | Background | Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19. |
| 12485966 | Background | National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available. |
| 9738608 | Background | Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789. |
| 7815302 | Background | Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063. |
| 7744171 | Background | Shifren K, Hooker K. Stability and change in optimism: a study among spouse caregivers. Exp Aging Res. 1995 Jan-Mar;21(1):59-76. doi: 10.1080/03610739508254268. |
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 2782256 | Background | Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 17199462 | Background | Krantz DS, Olson MB, Francis JL, Phankao C, Bairey Merz CN, Sopko G, Vido DA, Shaw LJ, Sheps DS, Pepine CJ, Matthews KA. Anger, hostility, and cardiac symptoms in women with suspected coronary artery disease: the Women's Ischemia Syndrome Evaluation (WISE) Study. J Womens Health (Larchmt). 2006 Dec;15(10):1214-23. doi: 10.1089/jwh.2006.15.1214. |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |