NCT02900534已完成不适用
Evaluation of a Randomised Guided Internet-based Self-help Intervention for Older Adults Who Seek Support for Coping With Prolonged Grief Symptoms After Marital Bereavement or Divorce - LIVIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Grief symptoms
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an internet-based self-help intervention for older adults with prolonged grief symptoms after spousal bereavement or separation/divorce. The study design is a randomized trial with a waiting control condition of 12 weeks and a follow-up after 6 months. The investigators will test the following main hypotheses:
- The intervention group shows a significant decrease in grief symptoms, psychological distress, depression symptoms and embitterment, and a significant increase in life satisfaction, as well as session related outcomes from baseline to 12 weeks post intervention assessment.
- The effects in the intervention group are larger than the effects in the waiting control group.
- These effects are stable from the post measure at 12 weeks to the 6-month follow-up.
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Marital bereavement or separation/divorce. Both events should have happened more than 6 months before participating in the study.
- •Seeking support for coping with grief symptoms
- •Internet access
- •Mastery of the German language
- •Informed Consent
排除标准
- •Acute suicidality (BDI Suicide item > 1 or suicidal ideation in the telephone interview)
- •No emergency plan: In the telephone interview, an emergency plan will be developed which specifies a health care professional, who participants can turn to in an acute crisis. If no such person or health care service can be found, individuals will be excluded from the intervention.
- •Severe psychological or somatic disorders which need immediate treatment.
- •Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
- •Prescribed drugs against depression or anxiety lead to an exclusion if prescription or dosage has changed in the month prior or during the self-help intervention.
- •Inability to follow the procedures of the study, e.g. due to comprehension problems
结局指标
主要结局
Grief symptoms
时间窗: 6 months after the start of the intervention
Texas Revised Inventory of Grief (German version, Znoj,2008; Faschingbauer, 1981)
Psychological distress
时间窗: 6 months after the start of the intervention
Brief Symptom Inventory (German version, Franke, 2000)
次要结局
- Depression symptoms(6 months after the start of the intervention)
- Satisfaction with life(6 months after the start of the intervention)
- Embitterment(6 months after the start of the intervention)
研究者
研究点 (2)
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