Positive Psychology Program in Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Behavioral: Multicomponent Psychological Program (MPP)

• Registration Number: NCT05287061
• Lead Sponsor: Hospital Universitario 12 de Octubre

Brief Summary

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.

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 Timeline

• Study Start: 2017-07-17
• Primary Completion: 2018-07-01
• Study Completion: 2019-07-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-18
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP):	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain