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Clinical Trials/ChiCTR2300068803
ChiCTR2300068803Not yet recruitingEarly Phase 1

接纳承诺疗法对冠心病介入术后患者多维度干预效果研究

山东省自然科学基金2 sites in 1 countryStarted: March 1, 2023Last updated:
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Trial Snapshot

Phase
Early Phase 1
Status
Not yet recruiting
Sponsor
Locations
2
Primary Endpoint
心理灵活性
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  1. 探讨接纳承诺疗法对冠心病介入术后患者疾病接纳 / 心理灵活性的干预效果；
  2. 探讨接纳承诺疗法对冠心病介入术后患者心理、行为、生理多维度结局指标的影响。

Study Design

Study Type
干预性研究
Primary Purpose
随机平行对照
Masking
None

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1.符合 WHO 及我国相关指南制定的冠心病诊断标准；
  • •2.初次接受介入治疗；
  • •3.年龄≥18 岁，神志清楚，能进行正常沟通交流；
  • •4.自愿配合并签订知情同意书的患者。

Exclusion Criteria

  • •1.认知障碍或无法准确理解问卷问题的患者；
  • •2.病情不稳定的患者；
  • •3.合并重要器官功能障碍的患者；
  • •4.无运动能力或根据 2020 冠心病心脏康复基层指南判定运动风险等级分层为高危，需在严密的医学监护下进行运动康复训练的患者。

Arms & Interventions

干预组

对照组

Outcomes

Primary Outcomes

心理灵活性

Time Frame: 基线,初次干预后 3 个月,初次干预后 6 个月

Secondary Outcomes

  • 认知融合(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 承诺行动(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 负性情绪(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 运动代谢指数(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 体质指数(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 高密度脂蛋白胆固醇(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 低密度脂蛋白胆固醇(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 总胆固醇(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 甘油三酯(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 炎症因子(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 氧化因子(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 高密度脂蛋白功能(基线,初次干预后 3 个月,初次干预后 6 个月)
  • 低密度脂蛋白功能(基线,初次干预后 3 个月,初次干预后 6 个月)

Investigators

Sponsor
山东省自然科学基金

Study Sites (2)

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