Clinical trial NCT06838351: Drawing and Anxiety Study
Official title: Drawing and Anxiety Study: Investigation of a Guided-Drawing and Mindfulness Intervention to Reduce Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: anxiety
mindfulness
drawing
RSA
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 280
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Procedure

Following informed consent (\~10 minutes), participants complete questionnaires to capture demographic (age, race, gender) information and individual differences in anxiety symptoms and emotion regulation difficulties (SCAARED, DERS-SF). After the questionnaires, cardiac activity monitors are applied (\~15 minutes), and participants are seated to complete state questionnaires and sitting cardiac resting state (8 minutes). After completion of the pre-drawing activity portion, the experimenter returns to the observation room and prepares the drawing session to which the participant has been randomly assigned. Participants are seated in front of a desktop computer. The experimenter places two pencils, a pencil sharpener, and an 8.5" X 11" blank sketchbook on the table in front of the participant. They are read the following instructions aloud and the experimenter leaves the room:

"Next, you're going to watch a video that will walk you through a drawing exercise. You have a pencil and some paper here to use. I'll leave the room, and you will not be asked to show your drawing to anyone. The video will explain everything else you need to know. When I leave the room, press the space bar to begin the video when you are ready. I'll be back shortly after the video is done playing."

In the guided drawing 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). In the free drawing group, participants watch a video with brief instructions and then were asked to draw whatever they would like. In the basic control group, participants are asked to complete simple paper and pencil activities (e.g., connect the dots, mazes) on their own.

After completion of the drawing session (\~20 minutes), participants again complete state questionnaires and sitting cardiac resting state (8 minutes). ECG electrodes were then removed (\~5 minutes), and participants complete closing questionnaires (\~10 minutes). Upon closing questionnaires, participants were given a debriefing document explaining the study's purpose and experimenters answered any questions they had (\~5 minutes). Participants spend approximately 90 minutes in the laboratory.

One week after the laboratory visit, participants are sent a link, via email, to their follow-up questionnaires including SCAARED.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: State anxiety
timeFrame: State anxiety changes are evaluated from baseline (before drawing session) to post-drawing (i.e., about 30 minutes after baseline).
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: From baseline (before drawing session) to one week later (7 days after lab visit)
Other outcomes:
measure: Respiratory Sinus Arrythmia
timeFrame: From baseline (pre-drawing), throughout drawing session (~20 minutes), and to post-drawing (about 36 minutes after baseline start).
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Sarah Myruski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman, E.A., Xia, M., Fosco, G. et al. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess 38, 443-455 (2016). https://doi.org/10.1007/s10862-015-9529-3
citation: Angulo M, Rooks BT, Gill M, Goldstein T, Sakolsky D, Goldstein B, Monk K, Hickey MB, Diler RS, Hafeman D, Merranko J, Axelson D, Birmaher B. Psychometrics of the screen for adult anxiety related disorders (SCAARED)- A new scale for the assessment of DSM-5 anxiety disorders. Psychiatry Res. 2017 Jul;253:84-90. doi: 10.1016/j.psychres.2017.02.034. Epub 2017 Feb 17.
citation: Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.