The Effects of an Intermodal Art Therapy Program on Depression, Anxiety, Stress, and Emotion Regulation Skill Levels in Nursing Students: A Randomized Controlled Study

April 24, 2026 updated by: Atlas University
Nursing students face stress during their education, especially when transitioning to clinical practice; poorly managed stress reduces academic achievement and increases levels of depression and anxiety. Therefore, developing students' emotional awareness and coping skills is important. Art therapy is an effective method that supports individuals in self-expression and the development of emotion regulation skills. Although the literature shows positive effects of art-based interventions on psychological well-being, there are limited randomized controlled studies that address depression, anxiety, stress, and emotion regulation skills together in nursing students. Accordingly, this study aims to determine the effect of an intermodal art therapy program on these variables in nursing students. The research was planned as a two-group, single-blind, observational, randomized controlled interventional study. The population of the study will consist of 1st and 2nd-year nursing students studying at Istanbul Atlas University, and 44 students meeting the inclusion-exclusion criteria will constitute the sample of the study. The intermodal art therapy program will be applied to the intervention group. Data; Data will be collected using an Individual Demographic Form, the Depression, Anxiety, Stress Scale, and the Emotion Regulation Skills Scale. Interventions will be administered in approximately grouped sessions, once a week, for a total of 8 sessions, each lasting 90 minutes, in a structured format. Data analysis will be performed using the SPSS 23.0 software package. Descriptive statistics such as frequency distribution, mean, and standard deviation will be used to define the sample size; pairwise pairs or the Wilcoxon pairwise test will be used for intragroup comparisons according to parametric test assumptions; and the Chi-square test will be used for the analysis of categorical data. A 95% significance level will be used to determine differences in the analyses. This study aims to contribute to strengthening the psychosocial care of nursing students by providing evidence on the effectiveness of an intermodal art therapy program applied to nursing students.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34408
        • Istanbul Atlas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being enrolled in the 1st or 2nd year of the Nursing Department at Istanbul Atlas University in the Spring Semester of 2025-2026,
  • Voluntarily participating in the research

Exclusion Criteria:

  • Having any comprehension or speech impairment,
  • Having any psychiatric diagnosis,
  • Being on any psychotropic medication,
  • Being enrolled in another program using a similar method that could affect the study's outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Art Therapy Group
In the study, it was planned to apply art therapy program the independent variable to the intervention group in 8 sessions of 90-120 minutes, one days a week, and no intervention was planned for the control group.
Behavioral: Art Therapy
Intermodal art therapy program
Other Names:
  • Intermodal art therapy
No Intervention: Comparison group
No intervention was planned for the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression, anxiety, stress
Time Frame: Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
Depression, Anxiety, Stress Scale (DASS-21) Lovibond and Lovibond (1995) created DASS-21 by shortening DASS-42. Sarıçam (2018) performed psychometric tests on the Turkish version of the "Depression Anxiety Stress-21 Scale (DASS-21)" in normal and clinical samples. In the normal sample, test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale. The scale, which is a four-point Likert type, consists of 7 questions each measuring the "depression, stress, and anxiety dimensions". In the depression subscale scores, 0-4 points indicate normal, 5-6 points mild, 7-10 points moderate, 11-13 points advanced, and 14 points and above indicate very advanced depression. In the anxiety subscale, scores between 0-3 indicate normal, 4-5 indicates mild, 6-7 indicates moderate, 8-9 indicates advanced, and 10 and above indicates very advanced anxiety levels. In the stress subscale, scores between 0-7 indic
Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
Emotion Regulation Skills
Time Frame: Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
Emotion Regulation Skills Scale (EDS) This is a scale developed by Berking and Znoj (2008) to determine individuals' emotion regulation skills. The adaptation of the scale into Turkish, and its validity and reliability study, were carried out by Vatan and Kâhya (2018). The scale is a self-report instrument consisting of 27 items with a five-point Likert scale (0=almost never, 4=almost always). The Emotional Behavior Test (EBT) encompasses nine sub-dimensions: awareness/attention (e.g., 'I paid attention to my feelings.'), bodily sensations (e.g., 'My physical sensations were a good indicator of how I felt.'), clarity (e.g., 'I was sure of which emotions I was experiencing.'), understanding (e.g., 'I was aware of why I felt that way.'), acceptance (e.g., 'I accepted my emotions.'), tolerance (e.g., 'I felt I could tolerate my negative emotions.'), preparedness for confrontation (e.g., 'Even though it made me feel uncomfortable or anxious, I did what I planned.'), self-support (e.g., 'I
Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share if necessary

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Contacting authors

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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