PDF(Pubmed)
Abstract：
BACKGROUND: Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being.
METHODS: A stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices.
CONCLUSIONS: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being.
BACKGROUND: ClinicalTrials.gov NCT05611112. Registered on October 28, 2022.
METHODS: A stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices.
CONCLUSIONS: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being.
BACKGROUND: ClinicalTrials.gov NCT05611112. Registered on October 28, 2022.
摘要：
背景：心理健康问题在患有慢性身体状况的患者中很常见，影响大约五分之一的患者。不良的心理健康与更糟糕的疾病结局和死亡率增加有关。问题解决疗法（PST）可能是针对这些患者不良心理健康的合适治疗方法。本研究方案描述了一项健康思维干预的随机对照试验，基于一般实践的干预措施，为2型糖尿病和/或缺血性心脏病且心理健康差的患者提供PST。
方法：将在丹麦的一般实践中进行为期1年的阶梯式楔形集群随机对照试验。在年度慢性护理咨询中，2型糖尿病和/或慢性缺血性心脏病患者将接受心理健康不良筛查.对照组的患者将接受常规护理，而干预组的患者将接受由全科医生（GP）或全科医生提供的PST治疗。比如护士,在从对照组过渡到干预组之前，他们将接受2天的PST课程。主要结果是6个月和12个月后抑郁症状的变化。次要结果包括心理健康的变化，焦虑,6个月和12个月后的糖尿病困扰（2型糖尿病患者）以及总胆固醇水平的变化，低密度脂蛋白（LDL）水平，和12个月后的血糖水平（糖尿病患者）。过程成果包括执行措施和影响机制。我们的目标是纳入总共188名患者，对应于大约14个平均大小的一般做法。
结论：健康思维试验调查了PST治疗对慢性病患者和心理健康差的影响。这将是第一个随机对照试验，确定PST治疗在一般实践中对慢性病患者的影响。这项研究的结果将为帮助全科医生提供相关见解，和全科医生管理心理健康差的患者。
背景：ClinicalTrials.govNCT05611112。2022年10月28日注册。
方法：将在丹麦的一般实践中进行为期1年的阶梯式楔形集群随机对照试验。在年度慢性护理咨询中，2型糖尿病和/或慢性缺血性心脏病患者将接受心理健康不良筛查.对照组的患者将接受常规护理，而干预组的患者将接受由全科医生（GP）或全科医生提供的PST治疗。比如护士,在从对照组过渡到干预组之前，他们将接受2天的PST课程。主要结果是6个月和12个月后抑郁症状的变化。次要结果包括心理健康的变化，焦虑,6个月和12个月后的糖尿病困扰（2型糖尿病患者）以及总胆固醇水平的变化，低密度脂蛋白（LDL）水平，和12个月后的血糖水平（糖尿病患者）。过程成果包括执行措施和影响机制。我们的目标是纳入总共188名患者，对应于大约14个平均大小的一般做法。
结论：健康思维试验调查了PST治疗对慢性病患者和心理健康差的影响。这将是第一个随机对照试验，确定PST治疗在一般实践中对慢性病患者的影响。这项研究的结果将为帮助全科医生提供相关见解，和全科医生管理心理健康差的患者。
背景：ClinicalTrials.govNCT05611112。2022年10月28日注册。
