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AnxietyD&ANCT06838351

Drawing and Anxiety Study

A study testing Guided Drawing Intervention in people with Anxiety, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
Guided Drawing Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
1 siteUnited States
Study dates
29 Sep 2022to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

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

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).

Read the 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.

Conditions
Anxiety
Being tested
Guided Drawing Intervention, Free Drawing Control, Basic Control
Keywords
anxiety, mindfulness, drawing, RSA
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided Drawing InterventionBehavioural

    The guided drawing activity is a 20 minute session which integrates mindfulness and drawing elements. 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).

  • Free Drawing ControlBehavioural

    Participants are instructed to draw freely for about 20 minutes.

  • Basic ControlBehavioural

    Participants are instructed to complete simple paper and pencil activities (e.g., mazes, connect the dots) for about 20 minutes.

Study groups in NCT06838351
Study groupRoleWhat they receive
Guided Drawing GroupExperimentalParticipants 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).
Receives: Behavioral: Guided Drawing Intervention
Free Drawing Control GroupActive comparatorIn 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.
Receives: Behavioral: Free Drawing Control
Basic Control GroupPlacebo comparatorIn 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.
Receives: Behavioral: Basic Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State anxiety

    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.

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

Secondary outcomes (1)
  1. Anxiety Symptoms

    The Screen for Adult Anxiety Related Disorders (SCAARED) is a 44-item self-report questionnaire designed for screening anxiety disorders in adulthood. 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). Total anxiety symptom scores were used as a secondary outcome.

    Measured: From baseline (before drawing session) to one week later (7 days after lab visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2025
  2. Study start29 Sep 2022
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838351
Sponsor's protocol ID
STUDY00021234
Acronym
D&A
Status last verified
Jul 2025
First submitted
13 Feb 2025
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared on the osf.oi platform. We will share scored self-report and physiological data pertinent to publications from this study.

Publications

  • Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23.

    PubMed 41522882
  • 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.

    PubMed 28359032
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Guided Drawing Intervention in people with Anxiety, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State anxiety (time frame: State anxiety changes are evaluated from baseline (before drawing session) to post-drawing (i.e., about 30 minutes after baseline).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06838351, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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Drawing and Anxiety Study (NCT06838351) | AzTrials