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临床试验/NCT01443234
NCT01443234已完成2 期

OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression

University of Oxford2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Change in score on Beck Depression Inventory - II

研究概览

简要总结

This research study is designed to investigate the effects of an online computer program, called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The OxIGen program will be delivered online over four weeks and with follow-up at one, three and six months. This will inform potential future development of this computerized task into an online intervention to modify negative thinking styles in depression.

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 (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Willing and able to give consent to the study
  • •Male or Female, aged between 18 and 65 years
  • •Current Major Depressive Episode (assessed by semi-structured clinical interview)
  • •Access to internet in order to complete the online program
  • •Able to travel to research centre for assessment appointments
  • •Fluent in written and spoken English

排除标准

  • •Meets criteria for current psychotic disorder
  • •History of mania or hypomania as assessed by semi-structured clinical interview, or has elsewhere received a diagnosis of Bipolar disorder
  • •Antidepressant medication begun or changed in dosage during last month
  • •Meets criteria for current substance abuse disorder
  • •Involved in other current treatment trials
  • •Currently receiving psychological therapy

研究组 & 干预措施

OxIGen program

Experimental

Internet based intervention taking place over 4 weeks

干预措施: OxIGen (Other)

OxIGen: control version

Placebo Comparator

A control version of the internet-based OxIGen intervention

干预措施: OxIGen: control version (Other)

结局指标

主要结局

Change in score on Beck Depression Inventory - II

时间窗: Baseline and post-intervention (4 weeks)

次要结局

  • Change in Neuroticism(Baseline and Post-Intervention (4 weeks))
  • Change in score on Quick Inventory of Depressive Symptoms - Self Report(Baseline and post-intervention (4 weeks))
  • Change in State-Trait Anxiety Inventory (Trait scale)(Baseline and Post-Intervention (4 weeks))
  • Change on Beck Anxiety Inventory(Baseline and Follow-Up (one month, three months, six months))
  • Change on Scrambled Sentences Task(Baseline and Post-Intervention (4 weeks))
  • Change on Life Orientation Test - Revised(Baseline and Follow-Up (one month, three months, six months))
  • Change on Prospective Imagery Test(Baseline and Follow-Up (one month, three months, six months))
  • Change on Behavioural Activation in Depression Scale(Baseline and Follow-Up (one month, three months, six months))
  • Change in IAPT Toolkit(Baseline and Post-Intervention (4 weeks))
  • Change on EuroQol-5D(Baseline and Post-Intervention (4 weeks))
  • Change on Beck Depression Inventory - II(Baseline and Follow-Up (one month, three months, six months))
  • Change on Quick Inventory of Depressive Symptoms - Self Report(Baseline and Follow-Up (one month, three months, six months))
  • Change on State-Trait Anxiety Inventory (Trait scale)(Baseline and Follow-Up (one month, three months, six months))
  • Change on IAPT Toolkit(Baseline and Follow-Up (one month, three months, six months))
  • Change on Euroqol-5D(Baseline and Follow-Up (one month, three months, six months))
  • Change on Neuroticism(Baseline and Follow-Up (one month, three months, six months))
  • Image Generation Task(Post-Intervention (4 weeks))
  • Change on Prospective Imagery Test(Baseline and Post-Intervention (4 weeks))
  • Change on Beck Anxiety Inventory(Baseline and Post-Intervention (4 weeks))
  • Change on Life Orientation Test - Revised(Baseline and Post-Intervention (4 weeks))
  • Change on Behavioural Activation in Depression Scale(Baseline and Post-Intervention (4 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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