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Positive Psychology Program in Cardiac Rehabilitation (PSICO-CARE)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multicomponent Psychological Program (MPP)
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP):

Cardiac Rehabilitation (CR)

Arm Description

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.

The patient will follow the usual process of cardiac rehabilitation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 11, 2022
Last Updated
March 17, 2022
Sponsor
Hospital Universitario 12 de Octubre
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1. Study Identification

Unique Protocol Identification Number
NCT05287061
Brief Title
Positive Psychology Program in Cardiac Rehabilitation
Acronym
PSICO-CARE
Official Title
Implementation of a Positive Psychology Program in Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario 12 de Octubre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP):
Arm Type
Experimental
Arm Description
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.
Arm Title
Cardiac Rehabilitation (CR)
Arm Type
No Intervention
Arm Description
The patient will follow the usual process of cardiac rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Multicomponent Psychological Program (MPP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of Optimism
Description
Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994
Time Frame
Week 10
Title
Level of Positive Emotions
Description
Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011)
Time Frame
Week 10
Title
Level of Anxiety
Description
Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
Time Frame
Week 10
Title
Level of Depression
Description
Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
Time Frame
Week 10
Title
Level of Coping
Description
Measured by the Brief-COPE Breve (Carver, 1997)
Time Frame
Week 10
Title
Level of Emotional Regulation
Description
Measured by the Emotional Regulation Difficulties Scale (Gratz & Roemer, 2014)
Time Frame
Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Héctor Bueno, MD, PhD
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Positive Psychology Program in Cardiac Rehabilitation

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