Is High Quality Effectiveness Research on Effective Stress Reduction in the Community Possible? -a Three-armed Parallel Pilot Trial in a Danish Municipality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Recruitment-rate
研究概览
简要总结
The aim was to assess the feasibility and to improve the quality of a definitive Randomised Controlled Trial (RCT) with the purpose to investigate the effectiveness of stress reduction programmes in the community. (A definitive RCT = an RCT with statistical power). Intermediate aims: to investigate 1) the potential generalizability: the accept among the target population (people with perceived stress) of participating in an RCT, including a description of the participant characteristics and the recruitment time ; 2) the risk of intervention effect dilution: the accept of allocated intervention in terms of programme completion ; 3) the risk of contamination: potential participation in (other) stress reduction treatment beyond the allocated intervention or non-intervention ; 4) the risk of selection problems or -bias: the lost to follow-up in the trial arms ; and finally, 5) the risk of information problems: the accept among participants of chosen outcome measurements, sensitivity of chosen outcome measures to detect effects, and indications of potential effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •at least 18 years old
- •able to understand, speak, and read Danish.
排除标准
- •acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- •abuse of alcohol, drugs, medicine
- •pregnancy.
结局指标
主要结局
Recruitment-rate
时间窗: over 4 months
Accept among total target group
Intervention-competition-rates participation
时间窗: over 8 weeks
Accept of the MBSR and the LSR programme defined by participation in \>4 meetings
Proportions_ lost-to-follow-up
时间窗: over 8-10 weeks
Risk of selection bias. Proportions of allocated participants lost to follow-up
Proportions_other_treatment
时间窗: over 8 weeks
Risk of dilution of intervention effects. Proportions of allocated participants that have participated in other stress reduction treatment during the trial
次要结局
- Proportions_Completed_PSS(twice over 8-10 weeks)
- Proportions_Completed_WHO_5(twice over 8-10 weeks)
- Proportions_Completed_FFMQ(twice over 8-10 weeks)
- Proportions_Completed_EQ(twice over 8-10 weeks)
- Proportions_measured_weight(twice over 8-10 weeks)
- Proposed_Effects_waist(over 8-10 weeks)
- Proposed_Effects_crp(over 8-10 weeks)
- dehydroepiandrosterone-sulfate (DHEAS)(over 8-10 weeks)
- Proportions_Completed_BRS(twice over 8-10 weeks)
- Proportions_measured_sysbp(twice over 8-10 weeks)
- Proportions_Completed_SCS(twice over 8-10 weeks)
- Proportions_measured_waist(twice over 8-10 weeks)
- Proportions_completed_tova(twice over 8-10 weeks)
- Proportions_measured_cholesterol(twice over 8-10 weeks)
- Proposed_Effects_PSS(over 8-10 weeks)
- Proposed_Effects__ARSQ(over 8-10 weeks)
- Proposed_Effects_FFMQ(over 8-10 weeks)
- Proposed_Effects_sysbp(over 8-10 weeks)
- Proportions_Completed_ARSQ(twice over 8-10 weeks)
- Proportions_measured_il6(twice over 8-10 weeks)
- Proposed_Effects_SCL_5(over 8-10 weeks)
- Proposed_Effects_BRS(over 8-10 weeks)
- Proportions_Completed_SCL_5(twice over 8-10 weeks)
- Proportions_measured_diabp(twice over 8-10 weeks)
- Proportions_measured_crp(twice over 8-10 weeks)
- Proposed_Effects_WHO_5(over 8-10 weeks)
- Proposed_Effects_SCS(over 8-10 weeks)
- Proposed_Effects_cholesterol(over 8-10 weeks)
- Proposed_Effects_EQ(over 8-10 weeks)
- Proposed_Effects_weight(over 8-10 weeks)
- Proposed_Effects_diabp(over 8-10 weeks)
- Proposed_Effects_tova(over 8-10 weeks)
- Proposed_Effects_il6(over 8-10 weeks)