跳至主要内容
临床试验/NCT03692988
NCT03692988已完成不适用

Dignity Therapy: a Brief Psychological and Existential Intervention for Patients With Early Dementia and Their Family. A Randomized Controlled Trial

University of Zurich2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia

研究概览

简要总结

Developed by Harvey M. Chochinov in 2005, Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share. DT has shown to improve quality of life and a sense of dignity, as well as supporting relatives in the process of grievance. Featuring a gradual loss of memories of the past, decline of cognitive functions and awareness of self, dementia can be regarded as a life-limiting or life-changing illness, which is often accompanied by significant psychological stress. DT may help patients and their relatives reduce this stress. Yet, no studies have been conducted to determine the benefits of DT in patients with early stage dementia (ESD). This study investigates the feasibility and acceptance of DT by patients with (very) mild dementia (CDR: 0.5 - 1.5) and their relatives, as well as their overall satisfaction. This study further seeks to determine the effects of DT on sense of dignity, quality of life, dyadic coping, and levels of anxiety and depression in a randomized controlled design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Signed Informed Consent
  • Diagnosis of very mild dementia
  • older 18 years of age
  • Study partner (life partner, relative, close friend) available

排除标准

  • Unable to speak and read German
  • Physical or cognitive incapacity to participate

结局指标

主要结局

Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia

时间窗: 10 days post randomization

Acceptance based on the participation and refusal rate and dropout rate.

Overall satisfaction of patients and their relatives

时间窗: 10 days post randomization

Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.

次要结局

  • Psychological distress(10 days post randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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