Positive Psychology Program in Cardiac Rehabilitation

NCT05287061 | Completed

• 1 other identifier: 17/171
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (6)

• Level of Optimism

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

  Week 10

• Level of Positive Emotions

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

  Week 10

• Level of Anxiety

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

  Week 10

• Level of Depression

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

  Week 10

• Level of Coping

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

  Week 10

• Level of Emotional Regulation

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

  Week 10

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Multicomponent Psychological Program (MPP)

Cardiac Rehabilitation (CR)

NO INTERVENTION

The patient will follow the usual process of cardiac rehabilitation.

Interventions

Multicomponent Psychological Program (MPP) BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Acute Coronary Syndrome (ACS) referred to the CR Program and consent to participate in the trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (1)

• Magan I, Jurado-Barba R, Moreno G, Ayan-Sanz MP, Izquierdo-Garcia J, Corradi G, Tello R, Bueno H. PsicoCare: a pilot randomized controlled trial testing a psychological intervention combining cognitive-behavioral treatment and positive psychology therapy in acute coronary syndrome patients. Front Psychol. 2024 Nov 19;15:1420137. doi: 10.3389/fpsyg.2024.1420137. eCollection 2024.

  PMID: 39629185 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Héctor Bueno, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 18, 2022
• Study Start: July 17, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)