NCT06838351

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

February 13, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

anxietymindfulnessdrawingRSA

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Anxiety Symptoms

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

Other Outcomes (1)

  • Respiratory Sinus Arrythmia

    From baseline (pre-drawing), throughout drawing session (~20 minutes), and to post-drawing (about 36 minutes after baseline start).

Study Arms (3)

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).

Behavioral: Guided Drawing Intervention

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.

Behavioral: Free Drawing Control

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.

Behavioral: Basic Control

Interventions

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).

Guided Drawing Group

Participants are instructed to draw freely for about 20 minutes.

Free Drawing Control Group
Basic ControlBEHAVIORAL

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

Basic Control Group

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

    PMID: 28359032BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sarah Myruski, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 20, 2025

Study Start

September 29, 2022

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
IPD will be available upon submission of manuscripts for review and remain available via link provided by the researchers and/or corresponding author(s).
Access Criteria
Reviewers and other interested researchers will be able to access the IPD via our osf.oi repository which will be linked in any relevant publications or journal submissions.

Locations