Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
275 participants
INTERVENTIONAL
2022-09-29
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility of a Mental-Health Intervention Based on Contemplative Sleep Practices
NCT07217340
Augmenting Mindfulness Training Through Experience-driven Neurofeedback
NCT02413177
Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli
NCT03206437
Influence of the Coloring of a Complex Form on Anxiety Associated With Care.
NCT03489980
Mindfulness Meditation for Cognition and Mood
NCT01946893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Guided Drawing Group
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).
Guided Drawing Intervention
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 Control Group
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.
Free Drawing Control
Participants are instructed to draw freely for about 20 minutes.
Basic Control Group
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.
Basic Control
Participants are instructed to complete simple paper and pencil activities (e.g., mazes, connect the dots) for about 20 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Guided Drawing Intervention
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 Control
Participants are instructed to draw freely for about 20 minutes.
Basic Control
Participants are instructed to complete simple paper and pencil activities (e.g., mazes, connect the dots) for about 20 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to speak, read and understand English
Exclusion Criteria
* Not able to speak, read and understand English
13 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Penn State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Myruski
Assistant Research Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Myruski, PhD
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State University
University Park, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00021234
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.