目的:本研究的主要目的是探讨接受和承诺疗法(ACT)对同时改变冠心病患者心脏康复(CR)的风险和心理健康生物学指标的短期疗效。
方法:这是一项双臂随机对照试验,手工,基于ACT的常规护理干预(UC)。
方法:本研究在意大利的一个门诊CR病房进行。数据收集时间为2016年1月至2017年7月。
方法:纳入92例患者,ACT组(n=59)和对照组(n=33)的不平衡随机化比为2:1。85例患者完成了ACT(n=54)和UC(n=31)干预措施,并进行了分析。
方法:对照组接受UC,为期6周的多学科门诊CR计划,包括锻炼训练,教育咨询和体检。实验组,除了UC,参加了心脏疾病接受和承诺治疗(ACTonHEART)干预,包括基于ACT的三个小组会议。
结果:主要结局是低密度脂蛋白(LDL)胆固醇,静息收缩压,体重指数(BMI)和心理总体幸福感指数(PGWBI)衡量。在基线和CR结束时评估结果指标。
结果:基于线性混合模型,对于任一主要结局,均未观察到显著的组×时间交互作用(β,95%CI:PGWBI=-1.13,-6.40至-4.14;LDL胆固醇=-2.13,-11.02至-6.76;收缩压=-0.50,-10.76至-9.76;舒张压=-2.73,-10.12至-4.65;BMI=-0.16,-1.83至-1.51,所有p值>0.05)或次要结局(所有p值>0.05)。发现PGWBI总量具有显著的时间效应(β=4.72;p=0.03)。
结论:尽管分析显示结果无效,研究结果可以为未来基于ACT的CR干预措施的设计提供信息,并可以帮助研究人员在ACT干预措施的理想化实施与现有CR计划的结构限制之间取得平衡.
背景:NCT01909102。
OBJECTIVE: The main objective of the study is to investigate the short-term efficacy of Acceptance and Commitment Therapy (ACT) on the simultaneous modification of biological indicators of risk and psychological well-being in patients with coronary heart disease attending cardiac rehabilitation (CR).
METHODS: This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC).
METHODS: The study was conducted in an outpatient CR unit in Italy. Data collection took place from January 2016 to July 2017.
METHODS: Ninety-two patients were enrolled and randomised, following an unbalanced randomisation ratio of 2:1 to the ACT group (n=59) and the control group (n=33). Eighty-five patients completed the ACT (n=54) and the UC (n=31) interventions and were analysed.
METHODS: The control group received UC, a 6 weeks multidisciplinary outpatient CR programme, encompassing exercise training, educational counselling and medical examinations. The experimental group, in addition to UC, participated in the Acceptance and Commitment Therapy on HEART disease (ACTonHEART) intervention encompassing three group sessions based on ACT.
RESULTS: The primary outcomes were Low Density Lipoproteins (LDL)cholesterol, resting systolic blood pressure, body mass index (BMI) and psychological well-being measured by the Psychological General Well-Being Index (PGWBI). Outcome measures were assessed at baseline and at the end of CR.
RESULTS: Based on linear mixed models, no significant group × time interaction was observed for either the primary outcomes (β, 95% CI: PGWBI =-1.13, -6.40 to -4.14; LDL cholesterol =-2.13, -11.02 to -6.76; systolic blood pressure =-0.50, -10.76 to -9.76; diastolic blood pressure =-2.73, -10.12 to -4.65; BMI =-0.16, -1.83 to -1.51, all p values >0.05) or the secondary outcomes (all p values >0.05). A significant time effect was found for the PGWBI total (beta=4.72; p=0.03).
CONCLUSIONS: Although analyses revealed null findings, the results can inform the design of future ACT-based CR interventions and can help researchers to strike a balance between the idealised implementation of an ACT intervention and the structural limitations of existing CR programmes.
BACKGROUND: NCT01909102.