跳至主要内容
临床试验/NCT01838889
NCT01838889已完成不适用

Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin

Lancashire Care NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)

研究概览

简要总结

This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is that depressed British women of South Asian origin receiving the group intervention will show significant improvements in terms of severity of depression as compared to the treatment as usual (TAU) 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
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics,
  • over the age of 16 years
  • living with their babies,
  • who meet the criteria for ICD-10 depression

排除标准

  • women with diagnosed physical or learning disability,
  • post-partum or other psychosis,
  • severely depressed
  • actively suicidal.

结局指标

主要结局

Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)

时间窗: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).

次要结局

  • Client Service Receipt Inventory (CSRI)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • EuroQoL-5 Dimensions (EQ-5D)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • Dyadic Adjustment Scale (DAS)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • The Parenting Stress Index (PSI)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • Multidimensional Scale of Perceived Social Support (MSPSS)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • Home Inventory (HI)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))
  • Hamilton Rating Scale for Depression (HRSD)(Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months))

研究者

发起方
Lancashire Care NHS Foundation Trust
申办方类型
Network
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验