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临床试验/NCT04117906
NCT04117906已完成不适用

Developing and Piloting an Online, Self-help Intervention for Anxiety

Canterbury Christ Church University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2019年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.

研究概览

简要总结

This study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety.

详细描述

This study is a pilot randomised controlled trial (RCT) comparing a brief, online self-help, anxiety management training course ('STAGE') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 3) and at follow-up (week 5).

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)

盲法说明

Measures will be completed online without direct involvement from the research team.

入排标准

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

入选标准

  • •having a score, at baseline, on the Generalised Anxiety Disorder 7 (GAD-7) scale of between 8 and 15, inclusive;
  • •having regular internet access;
  • •being based in the UK.

排除标准

  • •significant risk issues in the last year;
  • •currently receiving another psychological intervention, whether it be self-help or face-to-face;
  • •having recently (within the last six months) completed a psychological intervention.

研究组 & 干预措施

Wait-list control

No Intervention

The wait-list control group will receive access to the STAGE course after the trial is complete.

STAGE course

Experimental

干预措施: STAGE training for anxiety (Behavioral)

结局指标

主要结局

Change from baseline (week 0) at post-intervention (week 3) on the Generalised Anxiety Disorder 7 (GAD-7) scale.

时间窗: Post-intervention (3 weeks after baseline).

The Generalised Anxiety Disorder 7 (GAD-7) scale is a self-report measure of general anxiety, producing a total score between 0 and 21, with higher scores indicating greater levels of general anxiety.

次要结局

  • Change from baseline (week 0) at follow-up (week 5) on the Generalised Anxiety Disorder 7 (GAD-7) scale.(Follow-up (5 weeks after baseline).)
  • Change from baseline (week 0) at follow-up (week 5) on the Patient Health Questionnaire 9 (PHQ-9).(Follow-up (5 weeks after baseline).)
  • Change from baseline (week 0) at follow-up (week 5) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).(Follow-up (5 weeks after baseline).)
  • Change from baseline (week 0) at post-intervention (week 3) on the Experience Questionnaire (EQ).(Post-intervention (3 weeks after baseline).)
  • Change from baseline (week 0) at post-intervention (week 3) on the Patient Health Questionnaire 9 (PHQ-9).(Post-intervention (3 weeks after baseline).)
  • Change from baseline (week 0) at post-intervention (week 3) on the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).(Post-intervention (3 weeks after baseline).)
  • Change from baseline (week 0) at follow-up (week 5) on the Experience Questionnaire (EQ).(Follow-up (5 weeks after baseline).)
  • Change from baseline (week 0) at post-intervention (week 3) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).(Post-intervention (3 weeks after baseline).)
  • Change from baseline (week 0) at follow-up (week 5) on the Putting into Perspective subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).(Follow-up (5 weeks after baseline).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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