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Clinical Trials/NCT05287061
NCT05287061
Completed
Not Applicable

Implementation of a Positive Psychology Program in Cardiac Rehabilitation

Hospital Universitario 12 de Octubre1 site in 1 country104 target enrollmentJuly 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Hospital Universitario 12 de Octubre
Enrollment
104
Locations
1
Primary Endpoint
Level of Optimism
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2017
End Date
July 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Universitario 12 de Octubre
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Level of Optimism

Time Frame: Week 10

Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994

Level of Positive Emotions

Time Frame: Week 10

Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011)

Level of Depression

Time Frame: Week 10

Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)

Level of Anxiety

Time Frame: Week 10

Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)

Level of Coping

Time Frame: Week 10

Measured by the Brief-COPE Breve (Carver, 1997)

Level of Emotional Regulation

Time Frame: Week 10

Measured by the Emotional Regulation Difficulties Scale (Gratz \& Roemer, 2014)

Study Sites (1)

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