- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560241
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
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
44
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Intermodal art therapy program
Other Names:
|
|
No Intervention: Comparison group
No intervention was planned for the control group.
|
What is the study measuring?
Primary Outcome Measures
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
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)
April 29, 2026
Primary Completion (Estimated)
June 18, 2026
Study Completion (Estimated)
July 18, 2026
Study Registration Dates
First Submitted
April 24, 2026
First Submitted That Met QC Criteria
April 24, 2026
First Posted (Actual)
May 1, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 24, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Art Therapy
-
Uludag UniversityCompletedArt TherapyTurkey (Türkiye)
-
Medical University of South CarolinaNational Endowment for the Arts, United StatesActive, not recruitingPhysical Therapy | Hematopoietic Stem Cell Transplantation | Art TherapyUnited States
-
Sanko UniversityCompletedHemodialysis Patients | Art Therapy | Mandala PaintingTurkey
-
Istanbul Medeniyet UniversityCompletedAnger | Elderly | Art Therapy | Death Anxiety | Mandala ColoringTurkey (Türkiye)
-
HAN University of Applied SciencesCompletedTrauma | Psychological | Art TherapyNetherlands
-
Arba Minch UniversityNot yet recruitingAntiretroviral Therapy (ART) Adherence Among Adolescents Living With HIVEthiopia
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRecruitingPregnancy | HIV | Post-partum | HIV Antiretroviral Therapy (ART) AdherenceBotswana
-
Çankırı Karatekin UniversityNot yet recruitingChild Development | Art Therapy
-
University of ConnecticutNational Institute of Mental Health (NIMH)CompletedHealth Behavior | HIV Antiretroviral Therapy (ART) AdherenceUnited States
-
Association pour la promotion de la recherche en...Hôpital Côte de Nacre, CHU de CaenRecruitingHIV Antiretroviral Therapy (ART) AdherenceFrance
Clinical Trials on Art Therapy
-
King Abdullah University HospitalCompletedPTSD - Post Traumatic Stress DisorderJordan
-
Dokuz Eylul UniversityRecruitingAnxiety | Sleep Disturbance | Colorectal Cancer (Diagnosis)Turkey (Türkiye)
-
University of DerbyCompletedPerinatal Mental HealthUnited Kingdom
-
Hampton VA Medical CenterTerminatedPost-traumatic Stress Disorder | Stress Disorder, Post-TraumaticUnited States
-
University of ZurichRecruitingPosttraumatic Stress Disorder | Pancreas Cancer | Depression, Anxiety | Lower Gastrointestinal Neoplasms BenignSwitzerland
-
Mersin UniversityNot yet recruiting
-
Centre Hospitalier de PerigueuxUniversity Hospital, LimogesRecruitingTherapy-Associated CancerFrance
-
Dr. Sarkis MeterissianThe Cedars Cancer InstituteCompleted
-
Chonbuk National UniversityRecruiting