Efficacy of Systemic Stress Prevention Via Application SysLife© for Companies: A Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change from baseline stress and coping at 4 months
研究概览
简要总结
The purpose of this study is to investigate the efficacy of systemic stress prevention via SysLife© application in a prospective, interventive, balanced, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.
Research Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?
Hypothesis: We expect improvement of participants' subjective stress experience, goal achievement, systemic functioning in private and organisational social systems while using the SysLife© application.
详细描述
Background: Systemic prevention serves the prophylaxis of disease and/or illness, and/or damage to health. For social subsystems such as professional teams, there however still is a lack of effective preventive or health-promoting interventions. With the Prevention Act introduced in 2015 (Social Security Code, Germany: § 20 para. 1 SGB V), prevention now has to address the social context of people's everyday life as well ("setting/life-world approach"). Positive changes in terms of reduced stress perception or acute exposition to stress factors are supposed to be accompanied by improved systemic, psychological and physical well-being. This RCT will investigate the efficacy of the systemic stress prevention program SysLife© application.
Methods: This prospective, interventive, balanced, monocentric, explanatory pilot RCT compares an experimental group (n = 19) receiving SysLife© application with a control group (n = 19) with subsequent intervention, i.e. the SysLife@ application 4 months after the experimental group. The primary endpoint is the participants' subjective stress experience.
The data collection encompasses 5 measurement points: t1, i.e. baseline for the experimental group; t2: 2-month follow-up; t3: 4-month follow-up for the experimental group and baseline for the control group; t4: 6-month follow-up for the experimental group and 2-month follow-up for the control group; t5: 8-month follow-up for the experimental group and 2-month follow-up for the control group).
This allows for the calculation of trends considering the potential efficacy of the SysLife© application in the RCT design on the one hand (n = 19, 2-study arm approach), and in a cumulative study (n = 38, 1-study arm approach).
Research Question: Which implementations are necessary, based on the experience from this pilot RCT, to ensure the quality of a subsequent confirmatory RCT?
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
- Single (Outcomes Assessor)
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
- •Minimum age: 18 years
- •Interest in active use of the SysLife© application
- •Knowledge of German at native language level or the ability to use German language independently (at least B-level)
- •Only persons capable of giving consent will be included in the study
- •Written consent to participate after information about the study
排除标准
- •No written consent
结局指标
主要结局
Change from baseline stress and coping at 4 months
时间窗: baseline, 4-month follow-up
Stress and Coping Inventory (SCI; Satow, 2012): Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = not modified (positive), 7 = very strongly modified (negative)
Change from baseline chronic stress at 4 months
时间窗: baseline, 4-month follow-up
Trier Inventory on Chronic Stress (TICS; Schulz, Schlotz \& Becker, 2004): Self-report measure to assess chronic stress; Likert scale: 0 = never (positive), 4 = very often (negative)
次要结局
- Stress and Coping Inventory (SCI; Satow, 2012)(baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up)
- Trier Inventory on Chronic Stress (TICS; Schulz, Schlotz & Becker, 2004)(baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up)
- Goal Attainment Scaling (GAS; Grosse Holtforth & Grawe, 2002)(baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up)
- Experience in Social Systems (EXIS; Hunger et al., 2017)(baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up)
- Frequency of application use(baseline, 2-month follow-up, 4-month follow-up, 6-month follow-up, 8-month follow-up)
研究者
Christina Hunger-Schoppe
Chair for clinical psychology and psychotherapy
University of Witten/Herdecke