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临床试验/NCT03205332
NCT03205332已完成不适用

An Experimental Investigation of the Effects of Concrete Thinking on Worry, Problem-Solving and Cognitive Processing in Individuals With Generalized Anxiety Disorder

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2015年6月12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
121
试验地点
2
主要终点
Change in worry as measured by the Penn State Worry Questionnaire - Past Week

研究概览

简要总结

Generalized Anxiety Disorder (GAD) is a chronic condition whose hallmark feature is excessive and uncontrollable worry (American Psychiatric Association, 2013). Theories of GAD propose that specific cognitive biases are involved in the maintenance and etiology of chronic worry. One cognitive bias that plays a role in worrying is abstract thinking, or the tendency to "verbalize" thoughts and worries in a manner that is vague and lacking in detail. There is evidence that training depressed people to think more concretely improves depressive symptoms and depression-type thinking styles, and reduces emotional reactivity. Given that chronic worry and depression have commonalities (e.g., repetitive thinking styles, difficulties with problem-solving and attentional control, emotion dysregulation), concreteness training may help people who struggle with chronic worry. The main goals of this proof of concept experiment are 1) to test in individuals reporting chronic worry the effects of an active form of concreteness training that involves imagery practice (compared to a no training control condition) on frequency of worrying, problem solving quality, and worry-related processes; 2) to examine the degree to which concreteness training causes improvements in daily worry and negative affect during the 7 days of practice. The study design will provide us with an understanding on a more "macro" level of the potential short-term benefits and will at the same time allow us to see, on a more "micro" level, how training concreteness affects worry and mood on a day-to-day basis during a 7-day period. The findings from this study will inform relevant clinical literature about efficacious methods to reduce chronic worry.

详细描述

The main goals of this proof of concept experiment are 1) to test in individuals reporting chronic worry the effects of an active form of concreteness training that involves imagery practice (compared to a no training control condition) on frequency of worrying, problem solving quality, and worry-related processes; 2) to examine the degree to which concreteness training causes improvements in daily worry and negative affect during the 7 days of practice. Participants are recruited from the community via advertisements. Following a telephone screen, participants attend a baseline visit during which they complete the MINI interview. Those who continue to be eligible complete the outcome measures and are randomly assigned to either the experimental condition or the control condition. Participants assigned to the experimental condition receive training in concrete processing and learn how to complete the daily experience sampling diary. Participants assigned to the control condition do not receive training and learn how to complete the daily experience sampling diary. All participants then complete their assigned activities for 7 days. They then return to the lab to complete the outcome measures at post-test, 1 week follow up and 1 month follow up. Participants are then debriefed.

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
None

盲法说明

Eligibility Assessor

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in worry as measured by the Penn State Worry Questionnaire - Past Week

时间窗: this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up

次要结局

  • Change in negative problem orientation as measured by the Negative Problem Orientation Questionnaire(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in problem solving style as measured by the Social Problem Solving Inventory Revised(Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up)
  • Change in residual working memory capacity as measured by the Random Interval Generation Task(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in depressive symptoms as measured by the Centre for Epidemiological Studies Depression Scale(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in worry as measured by experience sampling completed during the 7 days between baseline and post test(Daily during 7-day intervention period)
  • Change in quality of problem-solving as measured by The Means-Ends Problem-Solving task(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in attentional control as measured by the Attentional Control Scale(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • - Change in interpretation bias as measured by the Ambiguous/ Unambiguous Situations Diary Extended(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)
  • Change in affect as measured by experience sampling completed during the 7 days between baseline and post test(Daily during 7-day intervention period)
  • Change in concreteness as measured by experience sampling completed during the 7 days between baseline and post test.(Daily during 7-day intervention period)
  • Change in GAD-Q-IV severity(this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naomi Koerner

Associate Professor

Toronto Metropolitan University

研究点 (2)

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