ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Adjustment Disorder - New Module 20 (ADNM-20)
研究概览
简要总结
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events.
详细描述
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events compared to a waiting list, in a randomized controlled trial design. Assessments are at baseline, 4-week and 3 months post-randomization. After 4 weeks, participants in the waiting control group get also access to the intervention.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Negative life event in a period between two weeks and two years before the study
- •Internet account
- •Sufficient German language skills
- •Informed consent
排除标准
- •Persons with moderate or severe depressive symptoms
- •Acute suicidality
- •Psychotic disorder, bipolar disorder
- •Severe, acute mental or physical disorder
研究组 & 干预措施
Active Group
Internet-based self-help
干预措施: Internet-based self-help program (Other)
Waiting List Group
结局指标
主要结局
Adjustment Disorder - New Module 20 (ADNM-20)
时间窗: 4-week
The ADNM-20 is a self-report assessment for adjustment disorder. It is aimed at adults who feel burdened by a critical life event. The ADNM-20 consists of two parts: an event list for recording stress and an item list for recording the resulting symptoms. In the event list, all burdens during the last two years are recorded and the subjectively highest burdens are named. On the basis of the item list, preoccupations and mismatch, the main symptom groups of the adaptation disorder according to ICD-11, as well as the concomitant symptoms of avoidance, depressiveness, anxiety, impulse control problems and functional impairment are recorded. The scale ranges from 0 (no stress) to 80 (high exposure).
次要结局
- Credibility/Expectancy Questionaire (CEQ)(4-week)
- Beck Depression Inventory (BDI)(4-week)
- Questionnaire for measuring patient satisfaction (ZUF-8)(4-week)
- System Usability Scale (SUS)(4-week)
- Short Form 12-Item Survey (SF-12)(4-week)
- Sense of Coherence Questionaire Revised (SOC-R)(4-week)
- Brief Symptom Inventory - Short Version (BSI-18)(4-week)