Acute Coronary SyndromePSICO-CARENCT05287061
Positive Psychology Program in Cardiac Rehabilitation
A study testing Multicomponent Psychological Program (MPP) in people with Acute Coronary Syndrome, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Multicomponent Psychological Program (MPP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jul 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Acute Coronary Syndrome (ACS) referred to the CR Program and consent to participate in the trial.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Positive Psychology Program in Cardiac Rehabilitation
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Multicomponent Psychological Program (MPP)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Psychological Program (MPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Psychological Program (MPP) |
| Cardiac Rehabilitation (CR) | No intervention | The patient will follow the usual process of cardiac rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Optimism
Measured by the Life Orientation Test - R (LOT-R; Scheier, Carver y Bridges, 1994
Measured: Week 10
Level of Positive Emotions
Measured by the PERMA Questionnaire (Positive emotion, Engagement, Relationships, Meaning, and Accomplishment Questionaire; Seligman, 2011)
Measured: Week 10
Level of Anxiety
Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
Measured: Week 10
Level of Depression
Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
Measured: Week 10
Level of Coping
Measured by the Brief-COPE Breve (Carver, 1997)
Measured: Week 10
Level of Emotional Regulation
Measured by the Emotional Regulation Difficulties Scale (Gratz \& Roemer, 2014)
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start17 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Héctor Bueno, MD, PhD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287061
- Sponsor's protocol ID
- 17/171
- Acronym
- PSICO-CARE
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39629185
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Positive Psychology Program in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05287061
- Acronym / sponsor ID
- PSICO-CARE / 17/171
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP): | Experimental | Behavioral: Multicomponent Psychological Program (MPP)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. |
| Cardiac Rehabilitation (CR) | No intervention | –The patient will follow the usual process of cardiac rehabilitation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Acute Coronary Syndrome (ACS) referred to the CR Program and consent to participate in the trial.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent 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. | Behavioural | Cardiac Rehabilitation (CR) + Multicomponent Psychological Program (MPP): |
Primary outcome
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 Anxiety
Time frame: Week 10
Measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)
Level of Depression
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 39629185Magan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Héctor Bueno, MD, PhD principal investigator
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Psychological Program (MPP) in people with Acute Coronary Syndrome, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Optimism (time frame: Week 10). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.