Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-01-02 @ 4:29 AM
Study NCT ID:
NCT05287061
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Psychology Program in Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Optimism', 'timeFrame': 'Week 10', 'description': 'Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994'}, {'measure': 'Level of Positive Emotions', 'timeFrame': 'Week 10', 'description': 'Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011)'}, {'measure': 'Level of Anxiety', 'timeFrame': 'Week 10', 'description': 'Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)'}, {'measure': 'Level of Depression', 'timeFrame': 'Week 10', 'description': 'Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)'}, {'measure': 'Level of Coping', 'timeFrame': 'Week 10', 'description': 'Measured by the Brief-COPE Breve (Carver, 1997)'}, {'measure': 'Level of Emotional Regulation', 'timeFrame': 'Week 10', 'description': 'Measured by the Emotional Regulation Difficulties Scale (Gratz \\& Roemer, 2014)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '39629185', 'type': 'DERIVED', 'citation': 'Magan I, Jurado-Barba R, Moreno G, Ayan-Sanz MP, Izquierdo-Garcia J, Corradi G, Tello R, Bueno H. PsicoCare: a pilot randomized controlled trial testing a psychological intervention combining cognitive-behavioral treatment and positive psychology therapy in acute coronary syndrome patients. Front Psychol. 2024 Nov 19;15:1420137. doi: 10.3389/fpsyg.2024.1420137. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Study to try to clarify the role of the dimensions of positive psychology as cardioprotective factors, controlling the classic CVR factors, both biomedical and psychosocial, as well as develop and test the effectiveness of a program Protocolized Psychological Intervention (PI), in a randomized clinical trial.', 'detailedDescription': 'It is intended to develop a collaborative study between Hospital Universitario 12 de October and the Faculty of Psychology of the Camilo José Cela University of Madrid to try to clarify the role of the dimensions of positive psychology as cardioprotective factors, controlling the classic CVR factors, both biomedical and psychosocial, as well as develop and test the effectiveness of a Protocolized Psychological Intervention, in a randomized clinical trial that will be developed in different phases of the cardiac recovery process in people who have had an acute coronary syndrome (ACS). The psychological intervention will include (1) a brief early intervention during hospitalization (based on psychoeducation, relaxation techniques, behavioral activation and focus on positive attitudes), and (2) during the follow-up phases, from two months after the hospital discharge, an intervention that will be made up of different packages depending on the individual profile (management of emotions, lifestyle healthy, post-traumatic growth and resilience, consolidation of intentions), versus a control group that will follow the standard cardiac rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with Acute Coronary Syndrome (ACS) referred to the CR Program and consent to participate in the trial.\n\nExclusion Criteria:\n\n* Presence of diagnosed major psychiatric disorders according to DSM 5 criteria, who will be referred directly to the Psychiatry service.\n* Inability to participate in a cardiac rehabilitation program for any reason.'}, 'identificationModule': {'nctId': 'NCT05287061', 'acronym': 'PSICO-CARE', 'briefTitle': 'Positive Psychology Program in Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Implementation of a Positive Psychology Program in Cardiac Rehabilitation', 'orgStudyIdInfo': {'id': '17/171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP):', 'description': 'The patients who are assigned to this treatment arm will have access to a psychological intervention program, which will use techniques from the positive psychology and motivational interviewing to work on several modules: Health pills (phase I), CR in phase II identical to the standar, and MPP interspersed in Phase II of the conventional program. An individualized program will be included in this branch, which will be added to the follow-up carried out in primary care. It will contain a post-traumatic growth module, an emotion management module, and an intention consolidation module.', 'interventionNames': ['Behavioral: Multicomponent Psychological Program (MPP)']}, {'type': 'NO_INTERVENTION', 'label': 'Cardiac Rehabilitation (CR)', 'description': 'The patient will follow the usual process of cardiac rehabilitation.'}], 'interventions': [{'name': 'Multicomponent Psychological Program (MPP)', 'type': 'BEHAVIORAL', 'description': 'Patients will receive "health pills" during hospital admission. This intervention will be brief for individual application, but without specific content for each person, protocolized in its content and tools, and with a cognitive-behavioral orientation. Its therapeutic objective is to provide the patient with immediate control strategies for negative emotions and some pattern of active and positive coping. Two months after hospital discharge, the patients will also receive a multicomponent psychological program of a group nature. Based on motivational interviewing and positive psychology, with two blocks: emotions and consolidation of intentions. Two individual sessions will be carried out at the beginning to be able to do individual orientation, plan the intervention protocol, determine the objectives, the group intervention, and the specific action packages that the patient will receive.', 'armGroupLabels': ['Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Héctor Bueno, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}