- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062383
Positive Emotions After Acute Coronary Events at Northwestern University (PEACE-NU)
Positive Psychology for Acute Coronary Syndrome Patients: A proof-of Concept Feasibility Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible patients must meet at least two of three World Health Organization criteria for an acute MI: typical chest pain, elevated cardiac enzymes, and electrocardiographic changes consistent with MI. For UA, participants must have new-onset angina within 2 months, exacerbation of previous angina with rest or with minimal exercise, or angina within 2 weeks of MI.
- Suboptimal adherence to health behaviors: eligible patients must meet a total item score of <15 (suboptimal) based on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items OR a total item score of 15 and a physical activity item score of <5.
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen,33 used to assess appropriate participation of medically ill patients in research studies and defined by a score of < 4.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and Dr. James Flaherty.
- Individuals who have undergone coronary artery bypass surgery, or any open heart surgery, in the past 1 year.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of intervention sessions completed by participants
Time Frame: 12 weeks
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Measured by number of intervention sessions completed by participants
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity
Time Frame: Baseline, 12 week
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As measured by accelerometer
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Baseline, 12 week
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Change in medication adherence
Time Frame: Baseline, 12 week
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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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Baseline, 12 week
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Change in dietary adherence
Time Frame: Baseline, 12 week
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
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Baseline, 12 week
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Change in positive affect
Time Frame: Baseline, 12 week
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Measured by the Positive and Negative Affect Schedule (PANAS)
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Baseline, 12 week
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Change in trait optimism
Time Frame: Baseline, 12 week
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Measured by the Life Orientation Test-Revised (LOT-R)
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Baseline, 12 week
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Change in state optimism
Time Frame: Baseline, 12 week
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Measured by the State Optimism Scale developed by Dr. Jeff Huffman
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Baseline, 12 week
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Change in anxiety
Time Frame: Baseline, 12 week
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Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
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Baseline, 12 week
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Change in depression
Time Frame: Baseline, 12 week
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Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
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Baseline, 12 week
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Change in physical function
Time Frame: Baseline, 12 week
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Measured by the Duke Activity Status Index (DASI)
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Baseline, 12 week
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Change in health-related quality of life
Time Frame: Baseline, 12 week
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Measured by the Short Form 12 (SF-12)
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Baseline, 12 week
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Change in adherence to health behaviors
Time Frame: Baseline, 12 week
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Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
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Baseline, 12 week
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Change in cardiac symptoms
Time Frame: Baseline, 12 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study
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Baseline, 12 week
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Change in physical activity
Time Frame: Baseline, 12 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ)
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Baseline, 12 week
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Change in perceived stress
Time Frame: Baseline, 12 week
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Measured by the perceived stress scale (PSS-4) measure
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Baseline, 12 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith Moskowitz, PhD, MPH, Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00208301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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