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临床试验/NCT03384615
NCT03384615已完成不适用

The Aarhus Bereavement Study (TABs): A Randomized Controlled Trial of the Efficacy of Compassion-Focused Therapy for Prolonged Grief Symptoms in Bereaved Adults

University of Aarhus2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年1月3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
82
试验地点
2
主要终点
Prolonged grief symptoms

研究概览

简要总结

Prolonged grief disorder (PGD) is a novel diagnostic entity proposed to describe a psychiatric disorder that occurs after the loss of a loved one. The disorder is to be implemented in The International Classification of Diseases 11th Revision (ICD-11), scheduled for release in 2018. Failure to recognize and treat PGD may have negative effects on health, functional capacity and quality of life. However, very little is known about the characteristics and treatment of PGD in adult Danish populations although such knowledge is much needed before introducing the disorder in Danish health services.

The present study aims to develop, test and disseminate a group-based treatment manual for PGD in bereaved partners and their adult children. People with high levels of symptoms will be recruited from a large-scale survey study examining frequency, predictors and prognosis of PGD symptoms (NCT03049007). Participants will be randomized to group-based compassion-focused therapy (CFT) for grief or a waitlist control group. Treatment effects will be estimated with prolonged grief symptoms as the primary outcome. Secondary outcomes include depressive symptoms, posttraumatic stress symptoms, symptoms of anxiety, and quality-of-life. The investigators expect that CFT will yield statistically significant effects on prolonged grief symptom compared with the waitlist control group. If CFT is shown to be efficacious in reducing prolonged grief symptoms, the investigators will conduct moderation and mediation analyses with the aim of identifying what works, for whom. Finally, the investigators will perform cost-effectiveness analyses by linking the data with healthcare utilization data from the Danish National registries.

详细描述

Aims

Our primary hypotheses are:

• CFT will have a statistically significant and long-term effect on PGD symptoms compared with the waitlist control group

Secondary hypotheses are:

  • Self-compassion self-criticism, rumination, and exposure to the loss will mediate the effects of CFT on PGD symptoms
  • Baseline PGD symptom level will moderate the intervention effects of CFT, with higher symptom level predicting larger symptom improvement
  • Gender, age, type of loss, attachment style, neuroticism, positive affect and social support will predict who will benefit most from treatment (moderator analyses)
  • CFT will reduce levels of depression, anxiety, and posttraumatic stress symptoms and increase quality-of-life (QoL) compared with the wait-list control group
  • Time spent on homework practice will moderate the intervention effects of CFT, with more time spent on homework predicting larger symptom improvement
  • CFT is a cost-effective psychological treatment compared with the waitlist-control group

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residence in the Central Region of Denmark
  • Status of partner or child to the deceased
  • A min. score of 25 on the PG-13 at 11 months after the loss

排除标准

  • Insufficient ability to understand Danish
  • Serious psychiatric disease, e.g., schizophrenia, bipolar disease
  • Acute suicidal ideation
  • Serious cognitive impairment, e.g., Alzheimer's disease
  • Active treatment for serious disease, e.g., chemotherapy for cancer

结局指标

主要结局

Prolonged grief symptoms

时间窗: From baseline (T1) to 6 months after the intervention (T4)

Prolonged grief (PG-13; Prigerson et al., 2009)

次要结局

  • Depression symptoms(From baseline (T1) to 6 months after the intervention (T4))
  • Prolonged Grief Disorder (PGD) (diagnostic criteria)(From baseline (T1) to 6 months after the intervention (T4))
  • Anxiety symptoms(From baseline (T1) to 6 months after the intervention (T4))
  • Utility measure(From baseline (T1) to 6 months after the intervention (T4))
  • Posttraumatic stress symptoms(From baseline (T1) to 6 months after the intervention (T4))
  • Well-being(From baseline (T1) to 6 months after the intervention (T4))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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