Acute Coronary Syndrome
Conditions
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.
Interventions
BEHAVIORALMulticomponent 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.
Sponsors
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Optimism | Week 10 | Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994 |
| Level of Positive Emotions | Week 10 | Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011) |
| Level of Anxiety | Week 10 | Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) |
| Level of Depression | 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) |
Countries
Spain
Outcome results
None listed