Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 336
- 试验地点
- 8
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) Anxiety
研究概览
简要总结
The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of Heart & Mind Trial is (I) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.
详细描述
The Heart & Mind Trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including four university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.
The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy.
The intervention consists of three steps: (1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with (CBT) training, plus usual care or usual care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
Because of the conditions required for psycho-educational interventions, it is not possible to blind the intervention staff and patients. All baseline information and clinical interviews are collected and performed before randomization. Physical tests, data collection, data management and administration will be done by blinded staff. Statistical analysis of outcomes and conclusions from these will be blinded. Results of the trial are analysed by an independent statistician, and the results will be interpreted by the research group. The conclusion will be prepared in two versions, before the allocation code is broken, with the two arms alternately assumed as intervention (one that assumes that arm A is the intervention, and second, that assumes that the arm B intervention).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥18 years
- •Diagnosed with cardiac disease
- •Speak and understand Danish
- •Score ≥8 on the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
- •HADS-A score must exceed the HADS-D score
- •Gives written informed consent.
排除标准
- 未提供
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) Anxiety
时间窗: 5 months
Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards. Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.
次要结局
- Becks Anxiety Inventory (BAI)(Baseline, 5 months and 12 months)
- Hospital Anxiety and Depression Scale (HADS) Anxiety(Baseline)
- Heart rate variability (HRV)(Baseline, 5 months)
研究者
Selina Kikkenborg Berg
Professor
Rigshospitalet, Denmark