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临床试验/NCT02900534
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

University of Bern2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年5月最近更新:
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:

  1. 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.
  2. The effects in the intervention group are larger than the effects in the waiting control group.
  3. 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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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