Positive Psychology Program in Cardiac Rehabilitation

Acute Coronary Syndrome Clinical Trial

— PSICO-CARE  

Official title:

Implementation of a Positive Psychology Program in Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287061
• Other study ID #: 17/171
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2022
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

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