Positive Psychology Program in Cardiac Rehabilitation (PSICO-CARE)

Implementation of a Positive Psychology Program in Cardiac Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: Multicomponent Psychological Program (MPP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with Acute Coronary Syndrome (ACS) referred to the CR Program and consent to participate in the trial.

Exclusion Criteria:

• Presence of diagnosed major psychiatric disorders according to DSM 5 criteria, who will be referred directly to the Psychiatry service.
• Inability to participate in a cardiac rehabilitation program for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP): 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.	Behavioral: Multicomponent Psychological Program (MPP); 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.
No Intervention: Cardiac Rehabilitation (CR); The patient will follow the usual process of cardiac rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Optimism	Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994	Week 10
Level of Positive Emotions	Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011)	Week 10
Level of Anxiety	Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)	Week 10
Level of Depression	Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)	Week 10
Level of Coping	Measured by the Brief-COPE Breve (Carver, 1997)	Week 10
Level of Emotional Regulation	Measured by the Emotional Regulation Difficulties Scale (Gratz & Roemer, 2014)	Week 10

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre
• Investigators: Principal Investigator: Héctor Bueno, MD, PhD, Hospital Universitario 12 de Octubre

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 17/171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No