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临床试验/NCT06838351
NCT06838351已完成不适用

Drawing and Anxiety Study: Investigation of a Guided-Drawing and Mindfulness Intervention to Reduce Anxiety

Penn State University1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2022年9月29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
275
试验地点
1
主要终点
State anxiety

研究概览

简要总结

Anxiety is among the most common emotional difficulties impacting well-being, highlighting the need for approachable anxiety-reduction tools. Both mindfulness and art-based interventions have been shown to decrease anxiety symptoms. These studies integrate these approaches via a novel guided drawing intervention, and tests effects on anxiety (pre/post drawing and at one-week follow-up) and physiological regulation (respiratory sinus arrhythmia). This registration includes two separate intervention studies with similar protocols but using different samples - one consisting of adolescents ages 13 to 17.9 years, and the other consisting of adults ages 18 to 25 years. Participants complete a laboratory visit during which they complete questionnaires about their emotions and anxiety, complete pre/post measures of cardiac physiology and state anxiety, and engage in a drawing session. Participants also complete a one-week follow-up self-report of anxiety symptoms. The intervention protocol is briefly described as follows: participants in each sample are randomly assigned to one of three groups (guided drawing, free drawing control, or basic control).

详细描述

Materials The Screen for Adult Anxiety Related Disorders (SCAARED) is a 44-item self-report questionnaire designed for screening anxiety disorders in adulthood. Factors assessed include generalized anxiety disorder (GAD), social anxiety disorder (SAD), separation anxiety disorder, and somatic/panic/agoraphobia. Items include statements such as 'I worry about people liking me', 'People tell me that I look nervous', 'I am afraid to be alone in the house', and 'When I get anxious, I feel dizzy'. Participants indicate their response on a 3-point scale (0 = not true or hardly true ever, 1 = somewhat true or sometimes true, 2 = very true or often true). Higher scores indicate a higher likelihood of anxiety disorder(s).

State-Trait Anxiety Inventory - State Scale. The State-Trait Anxiety Inventory - State Scale (STAI-S, Spielberger et al., 1983) is a 20-item self-report questionnaire designed to assess state anxiety (current anxiety feelings). Items include statements such as 'I feel calm', 'I feel strained', and 'I am jittery'. Participants indicate their response on a 4-point scale (1 = not at all, 4 = very much so). Higher scores indicate greater state anxiety.

Participants are also asked to report on their emotion regulation difficulties as an individual difference moderator variable. The Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) is an 18-item self-report questionnaire designed for assessing emotion regulation problems. Items include statements such as 'I care about what I am feeling', 'When I'm upset, I have difficulty focusing on other things', and 'When I'm upset, it takes me a long time to feel better'. Participants indicate their response on a 5-point scale (1 = almost never, 5 = almost always).

Cardiac Activity Recording and Data Processing Electrocardiogram (ECG) data was recorded using Mindware software with a sampling rate of 500 ms. Three electrodes were applied to the participants: on the distal right collarbone, the lower left rib, and the lower right rib to acquire the electrocardiogram (ECG) signal.

Experimenters manually mark the beginning and end of each episode in the cardiac data using Mindware's BioLab software. During the session, markers are placed to indicate the onset and offset of the pre-drawing period (8 minutes), the drawing session (~20 minutes; guided drawing or controls), and the post-drawing period (8 minutes). During the pre-drawing and post-drawing periods, participants complete state questionnaires (~2-3 minutes) and then remain seated until a total of 8 minutes elapsed.

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
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Within the specified age range (13 to 17.9 years for adolescent version; 18 to 25 years for adult version)
  • •Able to speak, read and understand English

排除标准

  • •Outside the specified age range (13 to 17.9 years for adolescent version; 18 to 25 years for adult version)
  • •Not able to speak, read and understand English

研究组 & 干预措施

Guided Drawing Group

Experimental

Participants in this group were asked to complete a guided drawing activity (~20 min). Participants were given a pencil and blank paper to use while they watched a pre-recorded video guiding them through a mindfulness and drawing activity. In the pre-recorded video, participants are instructed to draw elements of nature from exemplar photographs (e.g., leaves, twigs). The activity incorporates drawing with aspects of mindfulness meditation (i.e., being non-judgmental of thoughts and behaviors, focusing on breathing, and embodiment).

干预措施: Guided Drawing Intervention (Behavioral)

Free Drawing Control Group

Active Comparator

In the free drawing group, participants watched a video with brief instructions and then were asked to draw whatever they would like for about 20 minutes.

干预措施: Free Drawing Control (Behavioral)

Basic Control Group

Placebo Comparator

In the basic control group, participants were asked to complete simple paper and pencil activities (e.g., connect the dots, mazes) on their own for about 20 minutes.

干预措施: Basic Control (Behavioral)

结局指标

主要结局

State anxiety

时间窗: State anxiety changes are evaluated from baseline (before drawing session) to post-drawing (i.e., about 30 minutes after baseline).

State anxiety is measured via the State-Trait Anxiety Inventory - State Scale (STAI-S), a 20-item self-report questionnaire designed to assess state anxiety (current anxiety feelings). Participants report their state anxiety before and after the drawing session by responding to the STAI-S items (e.g., "I feel strained") using a scale from (1) not at all to (4) very much so. Sum scores are computed to quantify state anxiety before and after drawing, with possible scores ranging from 20 to 80, with higher scores indicated higher state anxiety.

次要结局

  • Anxiety Symptoms(From baseline (before drawing session) to one week later (7 days after lab visit))

研究者

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

Sarah Myruski

Assistant Research Professor

Penn State University

研究点 (1)

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