Bridging the Gap: A Multiple Baseline Design Study on the Effectiveness of a Mobile-based Stress Management Intervention in Adults on Waiting Lists for Mental Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress
研究概览
简要总结
This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.
详细描述
Prolonged waiting times for mental healthcare pose significant challenges, with nearly 100,000 people on waiting lists in the Netherlands as of December 2023. During this period, symptoms can worsen, daily functioning may decline, and quality of life decreases. Stappvoorstap was developed in co-creation with waitlist clients and experts-by-experience to address this gap. The app is based on stress-signaling plans used in Dutch mental healthcare and functions as an ecological momentary intervention. It measures perceived stress 2-4 times daily, creates visual overviews of stress patterns, and provides real-time coping suggestions, mindfulness exercises, informational articles, and personal stories from other clients. This study uses a nonconcurrent multiple baseline design with A-B-A design. Participants are randomly assigned to 3, 4, or 5-week baseline phases, followed by 4 weeks of app use, and 3 weeks of follow-up. Weekly assessments include the Perceived Stress Scale (PSS-10), Coping Self-Efficacy Scale (CSES-13), and WHOQOL-BREF. Both group-level and individual case analyses will be conducted using mixed-effects modeling and Tau-(BC) effect size measures.
Participants are recruited from mental health waiting lists across the Netherlands. As this is a mobile app-based intervention, participation is location-independent and takes place remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Currently on a waiting list at a mental health organization in the Netherlands.
- •Aged 18 years or older
- •Owns a smartphone and has the ability to operate it
- •Sufficient proficiency in Dutch or English language (at least B1 level)
排除标准
- •Currently enrolled in another medical-scientific research study
研究组 & 干预措施
Group 1: 3-week baseline
Participants receive 3 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (10 total measurements).
干预措施: Stappvoorstap: mobile self-management waitlist intervention (Behavioral)
Group 2: 4-week baseline
Participants receive 4 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (11 total measurements).
干预措施: Stappvoorstap: mobile self-management waitlist intervention (Behavioral)
Group 3: 5-week baseline
Participants receive 5 weeks of baseline measurements, 4 weeks of Stappvoorstap app intervention, and 3 weeks of follow-up (12 total measurements).
干预措施: Stappvoorstap: mobile self-management waitlist intervention (Behavioral)
结局指标
主要结局
Change in Perceived Stress
时间窗: Weekly measurements for 10-12 weeks (depending on group assignment)
Measured using the Perceived Stress Scale with 10 items (PSS-10). The PSS-10 is a validated self-report questionnaire assessing how stressful situations were perceived in the past week. Items are rated on a 5-point scale (1=never to 5=very often). Higher scores indicate higher perceived stress. Change from baseline phase to intervention phase, and to follow-up will be assessed.
次要结局
- Change in Coping Self-Efficacy(Weekly measurements for 10-12 weeks (depending on group assignment))
- Change in Quality of Life(Weekly measurements for 10-12 weeks (depending on group assignment))
研究者
Sevda Demirel
PhD Candidate
GGZ Centraal