Clinical trial NCT05287061: Positive Psychology Program in Cardiac Rehabilitation
Official title: Implementation of a Positive Psychology Program in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of Optimism
timeFrame: Week 10
measure: Level of Positive Emotions
timeFrame: Week 10
measure: Level of Anxiety
timeFrame: Week 10
measure: Level of Depression
timeFrame: Week 10
measure: Level of Coping
timeFrame: Week 10
measure: Level of Emotional Regulation
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Héctor Bueno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: