跳至主要内容
临床试验/NCT02902159
NCT02902159Unknown不适用

Randomised Controlled Trial of an Established Direct to Public Peer Support and E-therapy Programme (Big White Wall) Versus Information to Aid Self-management of Depression and Anxiety.

University of Nottingham2 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,200
试验地点
2
主要终点
Warwick-Edinburgh Mental Well-being Scale - 14 Item

研究概览

简要总结

A randomised controlled trial to compare the effect on wellbeing of an online peer review website (Big White Wall) compared to freely available online information (NHS Moodzone) for people with depression and anxiety.

详细描述

Introduction

Unipolar depression and anxiety are respectively the second and seventh leading causes of years lived with disability in the world among all health problems according to the World Health Organisation. Self-support methods of management of depression and anxiety through a population approach such as online therapy and peer support is attractive for a number of reasons including: the scale of the problem and the ability of current services to cope; providing choice about the management of their symptoms; creating personal empowerment; developing supportive social networks; recurrence prevention.

The use of public health interventions for physical conditions such as cigarette smoking, weight loss and diabetes is increasingly utilised and effective in reaching the wider public.

Big White Wall

Big White Wall (BWW) is a well-established digital service (website and apps) 3 that offers:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Live in the County of Nottinghamshire, including Nottingham City
  • •Scores between10-20 on the Personal Health Questionnaire (PHQ9) and/or 10+ on Genral Anxiety Disorder Scale (GAD7)
  • •Access to internet through a pc or smartphone (Windows, iOS, Android)
  • •Able and willing to give informed consent

排除标准

  • •Scores 21 or more on the PHQ-9 (severe depression)
  • •And /Or Scores 2 or 3 on PHQ-9 item "thoughts that you would be better off dead or of hurting yourself in some way".
  • •Participant does not feel that they are sufficiently proficient in the use of the English Language (BWW and Moodzone are only available in English)

研究组 & 干预措施

BWW

Experimental

Free access to online peer support through BWW for 6 months

干预措施: BWW Online Peer Support (Other)

MZ

Experimental

Access to NHS Moodzone Information Only

干预措施: NHS Moodzone Online Information (Other)

结局指标

主要结局

Warwick-Edinburgh Mental Well-being Scale - 14 Item

时间窗: 6 weeks

Change on the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) from baseline to week 6

次要结局

  • SF-12 v2 Health Survey 12(6, 12 & 26 weeks)
  • Work and Social Adjustment Scale 8 Item - Social Function 13(6, 12 & 26 weeks)
  • Warwick-Edinburgh Mental Well-being Scale - 14 Item(12 and 26 weeks)
  • Generalised Anxiety Disorder 7 Item Scale (GAD-7)(6, 12 & 26 weeks)
  • Personal Health Questionnaire 9 Item (PHQ-9) 11(6, 12 & 26 weeks)
  • 8-item social support measure14(6, 12 & 26 weeks)
  • 12-item Brugha Inventory of Life Events15(26 weeks)
  • 8-item Standardised Assessment of Personality-Abbreviated Scale (SAPAS(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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