Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Stress symptoms
研究概览
简要总结
In this single-blinded randomized controlled clinical trial 290 patients with stress or burnout will be investigated regarding the effectiveness of a digital therapeutic for improvement of stress level, the unguided online intervention reviga.
Inclusion criteria are: age 18-65 years, ICD-10 diagnosis Z73, operationalized as above average general stress level (PSS score > 21) and increased levels of work-related stress / burnout (OLBI score ≥ 2.18), living in Germany, working a minimum of 20h per week, having a stable treatment for at least 30 days at the time of inclusion, and consent to participation. Exclusion criterion is having plans to change the treatment in the upcoming three months at the time of inclusion.
Patients will be randomized and allocated to either an intervention group, receiving reviga in addition to treatment as usual (TAU), or a control group, receiving only TAU. The control group will be granted access to the program at the end of the study. Primary endpoint will be the perceived stress measured by the PSS score, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be anxiety symptoms, level of functioning, burnout symptoms, health-related quality of life, and sick days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All endpoints are patient-reported outcome measures (PROMs). Given that participants are aware of their study group (receiving reviga in addition to treatment as usual or only receiving treatment as usual), this trial is not blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years
- •living in Germany
- •employed (minimum of 20h/week)
- •ICD-10 diagnosis Z73, operationalized as above average general stress level (PSS score > 21) and increased levels of work-related stress / burnout (OLBI score ≥ 2.18)
- •stable treatment (psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
- •consent to participation
排除标准
- •plans to change treatment (psychotherapy, medication, ...) in the upcoming three months at the time of inclusion
结局指标
主要结局
Stress symptoms
时间窗: 3 months
Perceived Stress Scale (PSS-10). Total score ranging from 0-40; higher scores mean more stress symptoms (worse outcome).
次要结局
- Functioning(3 months, 6 months)
- Sick days(3 months, 6 months)
- Stress symptoms(6 months)
- Anxiety symptoms(3 months, 6 months)
- Burnout symptoms(3 months, 6 months)
- Health-related quality of life(3 months, 6 months)