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临床试验/NCT05287061
NCT05287061已完成不适用

Implementation of a Positive Psychology Program in Cardiac Rehabilitation

Hospital Universitario 12 de Octubre2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
2
主要终点
Level of Optimism

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Level of Optimism

时间窗: Week 10

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

Level of Positive Emotions

时间窗: Week 10

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

Level of Depression

时间窗: Week 10

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

Level of Anxiety

时间窗: Week 10

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

Level of Coping

时间窗: Week 10

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

Level of Emotional Regulation

时间窗: Week 10

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

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario 12 de Octubre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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