Psychiatric DisordersNCT07162428
The Effect of Art Therapy on Disease Severity and Anxiety Levels in Inpatients at a Psychiatry Clinic
A study testing Art Therapy in people with Psychiatric Disorders, run by Koç University.
Trial summary
The aim of this study is to examine the effect of art therapy applied to inpatients in the psychiatry ward on disease severity and anxiety levels. Art therapy is considered a complementary intervention that can positively contribute to the psychiatric recovery process by facilitating the expression and regulation of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Currently hospitalized in the psychiatry clinic and expected to remain hospitalized during the study period.
- No medical condition such as intellectual disability or organic mental disorder that would interfere with the administration of scales and tests.
- A PANSS score of ≤62 (since a score of 61 is considered the remission criterion in schizophrenia, patients scoring 62 or below will be included).
- A score between 5-18 on the Young Mania Rating Scale.
- Receiving treatment in the clinic for at least 3 days.
- Providing verbal and/or written informed consent to participate in the study.
Who cannot join
- Being in an acute psychotic episode or having severe psychotic symptoms (e.g., severe delusions, hallucinations) making the patient unsuitable for group participation.
- Clinical conditions involving excessive agitation or homicidal risk that make group participation inappropriate.
- Inability to actively participate in art therapy due to visual, hearing, or severe motor impairments.
- Patients for whom discharge is planned during the clinical course (e.g., those scheduled for discharge in less than 3 days).
- Diagnosis of an organic mental disorder (e.g., dementia, delirium).
- Severe physical illness or motor impairment preventing participation in group activities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to examine the effect of art therapy applied to inpatients in the psychiatry ward on disease severity and anxiety levels. Art therapy is considered a complementary intervention that can positively contribute to the psychiatric recovery process by facilitating the expression and regulation of an individual's emotional state.
This research will be conducted with a randomized controlled design and aims to demonstrate the effectiveness of art therapy practices within the clinical process through objective data. The originality of the study lies in the fact that art therapy will be implemented with individuals hospitalized in an acute psychiatric ward. In this respect, the study provides the opportunity to evaluate the applicability of art therapy even during crisis periods and carries the potential to make significant practice-oriented contributions to the field of mental health.
Read the detailed description
Mental health is currently defined as a significant public health issue on a global scale. Mental disorders manifest across a wide spectrum, ranging from mild anxiety disorders to behavioral abnormalities. Psychiatric illnesses not only diminish individuals' quality of life but also impose substantial social and economic burdens on healthcare systems.
Alternative and complementary treatment methods are gaining increasing importance in alleviating this burden. In this context, art therapy has recently attracted attention as a supportive method in psychiatric treatments. The British Association of Art Therapists (BAAT) defines art therapy as "a form of psychotherapy in which art materials are used as the primary medium of expression and communication," whereas the American Art Therapy Association (AATA) defines it as "a mental health and human services profession that integrates creative processes, psychological theory, and human experience".
Art therapy represents a multidimensional approach that encompasses various practices such as drama therapy, dance-movement psychotherapy, body therapy, music therapy, painting, drawing, and crafts. This form of therapy aims to promote recovery not only at the mental level but also at the physical and emotional levels in the treatment of psychiatric disorders .
Research has shown that art therapy enhances individual expressive abilities, facilitates emotion regulation, and provides a personalized healing process. It has been demonstrated to yield effective results particularly in post-traumatic stress disorder (PTSD), personality disorders, and mood disorders. Furthermore, its effectiveness in reducing depression in elderly individuals has been supported by randomized controlled trials. Similarly, studies on reducing anxiety levels in children have also reported positive outcomes.
This study aims to investigate the effect of art therapy practices on disease severity and anxiety levels among inpatients in a psychiatric ward, using a randomized controlled trial design. The originality of this study lies in its implementation of art therapy with individuals hospitalized in an acute psychiatric ward. In this regard, examining the direct impact of art therapy within the clinical process has the potential to provide significant practical contributions for both practitioners and the healthcare system.
- Conditions
- Psychiatric Disorders
- Being tested
- Art Therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
The art therapy sessions will be conducted by a certified art therapist who has completed a two-year training program, together with a psychiatric nurse who has completed a 4-hour training course on "Severe Personality Disorders and Therapeutic Interventions - Art Therapy." A clinical nurse and a psychiatry resident will also participate as observers. The therapist will deliver the intervention through semi-structured sessions, following a predefined content and method. These sessions are referred to as Semi-Structured Art Therapy Sessions.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy Intervention | Experimental | Participants in this group will receive art therapy sessions in addition to standard psychiatric care. The intervention will consist of 3 sessions per week, conducted on 5 consecutive days, with each session lasting approximately 50 minutes. Sessions will be carried out in groups of 8 participants and will focus on creative expression through drawing and painting. All sessions will be facilitated by a trained art therapist. Receives: Behavioral: Art Therapy |
| Control Group (Standard Care) | No intervention | Participants in this group will receive standard psychiatric care without additional art therapy sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Mania Rating Scale (YMRS)
The YMRS is an 11-item scale developed by Young et al. to assess the severity of manic episodes. Seven items are rated on a 5-point Likert scale and four items on a 9-point Likert scale, with a total score range of 0 to 44. The Turkish version has been validated for reliability and validity. The total score can range from 0 to 60, with higher scores indicating more severe manic symptoms.
Measured: Before and after each therapy session (daily assessments during the 5-day intervention week for each group). Each group receives one week of therapy; in total, three groups will complete the intervention over three consecutive weeks.
State-Trait Anxiety Inventory (STAI - Form I and II)
Self-report measure assessing state and trait anxiety, consisting of 20 items each, rated on a 4-point Likert scale.
Measured: Before and after each session across the 5-day intervention week for each group (three groups in total, over three weeks).
Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item scale developed by Kay et al. to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. Scores are rated across three subscales. The Turkish version has been validated by Kostakoğlu et al. In this scale (PANSS: Positive and Negative Syndrome Scale), as the score increases, symptoms/psychopathology become more severe. In other words, the higher the score, the greater the severity of symptoms and the greater the impairment in the patient's daily functioning.
Measured: Before and after each session across the 5-day intervention week for each group (three groups in total, over three weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion16 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the art therapy intervention group or the control group receiving standard care
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162428
- Sponsor's protocol ID
- tugbasahin
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art Therapy on Disease Severity and Anxiety Levels in Inpatients at a Psychiatry Clinic
- ClinicalTrials.gov ID
- NCT07162428
- Acronym / sponsor ID
- tugbasahin
- Conditions
- Psychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 16 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect of art therapy applied to inpatients in the psychiatry ward on disease severity and anxiety levels. Art therapy is considered a complementary intervention that can positively contribute to the psychiatric recovery process by facilitating the expression and regulation of an individual's emotional state.
This research will be conducted with a randomized controlled design and aims to demonstrate the effectiveness of art therapy practices within the clinical process through objective data. The originality of the study lies in the fact that art therapy will be implemented with individuals hospitalized in an acute psychiatric ward. In this respect, the study provides the opportunity to evaluate the applicability of art therapy even during crisis periods and carries the potential to make significant practice-oriented contributions to the field of mental health.
Detailed description
Mental health is currently defined as a significant public health issue on a global scale. Mental disorders manifest across a wide spectrum, ranging from mild anxiety disorders to behavioral abnormalities. Psychiatric illnesses not only diminish individuals' quality of life but also impose substantial social and economic burdens on healthcare systems.
Alternative and complementary treatment methods are gaining increasing importance in alleviating this burden. In this context, art therapy has recently attracted attention as a supportive method in psychiatric treatments. The British Association of Art Therapists (BAAT) defines art therapy as "a form of psychotherapy in which art materials are used as the primary medium of expression and communication," whereas the American Art Therapy Association (AATA) defines it as "a mental health and human services profession that integrates creative processes, psychological theory, and human experience".
Art therapy represents a multidimensional approach that encompasses various practices such as drama therapy, dance-movement psychotherapy, body therapy, music therapy, painting, drawing, and crafts. This form of therapy aims to promote recovery not only at the mental level but also at the physical and emotional levels in the treatment of psychiatric disorders .
Research has shown that art therapy enhances individual expressive abilities, facilitates emotion regulation, and provides a personalized healing process. It has been demonstrated to yield effective results particularly in post-traumatic stress disorder (PTSD), personality disorders, and mood disorders. Furthermore, its effectiveness in reducing depression in elderly individuals has been supported by randomized controlled trials. Similarly, studies on reducing anxiety levels in children have also reported positive outcomes.
This study aims to investigate the effect of art therapy practices on disease severity and anxiety levels among inpatients in a psychiatric ward, using a randomized controlled trial design. The originality of this study lies in its implementation of art therapy with individuals hospitalized in an acute psychiatric ward. In this regard, examining the direct impact of art therapy within the clinical process has the potential to provide significant practical contributions for both practitioners and the healthcare system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the art therapy intervention group or the control group receiving standard care
| Arm | Type | Receives |
|---|---|---|
| Art Therapy Intervention | Experimental | Behavioral: Art TherapyParticipants in this group will receive art therapy sessions in addition to standard psychiatric care. The intervention will consist of 3 sessions per week, conducted on 5 consecutive days, with each session lasting approximately 50 minutes. Sessions will be carried out in groups of 8 participants and will focus on creative expression through drawing and painting. All sessions will be facilitated by a trained art therapist. |
| Control Group (Standard Care) | No intervention | –Participants in this group will receive standard psychiatric care without additional art therapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Currently hospitalized in the psychiatry clinic and expected to remain hospitalized during the study period.
- No medical condition such as intellectual disability or organic mental disorder that would interfere with the administration of scales and tests.
- A PANSS score of ≤62 (since a score of 61 is considered the remission criterion in schizophrenia, patients scoring 62 or below will be included).
- A score between 5-18 on the Young Mania Rating Scale.
Key exclusion criteria (6 listed)
- Being in an acute psychotic episode or having severe psychotic symptoms (e.g., severe delusions, hallucinations) making the patient unsuitable for group participation.
- Clinical conditions involving excessive agitation or homicidal risk that make group participation inappropriate.
- Inability to actively participate in art therapy due to visual, hearing, or severe motor impairments.
- Patients for whom discharge is planned during the clinical course (e.g., those scheduled for discharge in less than 3 days).
- Diagnosis of an organic mental disorder (e.g., dementia, delirium).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art TherapyThe art therapy sessions will be conducted by a certified art therapist who has completed a two-year training program, together with a psychiatric nurse who has completed a 4-hour training course on "Severe Personality Disorders and Therapeutic Interventions - Art Therapy." A clinical nurse and a psychiatry resident will also participate as observers. The therapist will deliver the intervention through semi-structured sessions, following a predefined content and method. These sessions are referred to as Semi-Structured Art Therapy Sessions. | Behavioural | Art Therapy Intervention |
Primary outcome
Young Mania Rating Scale (YMRS)
Time frame: Before and after each therapy session (daily assessments during the 5-day intervention week for each group). Each group receives one week of therapy; in total, three groups will complete the intervention over three consecutive weeks.
The YMRS is an 11-item scale developed by Young et al. to assess the severity of manic episodes. Seven items are rated on a 5-point Likert scale and four items on a 9-point Likert scale, with a total score range of 0 to 44. The Turkish version has been validated for reliability and validity. The total score can range from 0 to 60, with higher scores indicating more severe manic symptoms.
State-Trait Anxiety Inventory (STAI - Form I and II)
Time frame: Before and after each session across the 5-day intervention week for each group (three groups in total, over three weeks).
Self-report measure assessing state and trait anxiety, consisting of 20 items each, rated on a 4-point Likert scale.
Positive and Negative Syndrome Scale (PANSS)
Time frame: Before and after each session across the 5-day intervention week for each group (three groups in total, over three weeks).
The PANSS is a 30-item scale developed by Kay et al. to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. Scores are rated across three subscales. The Turkish version has been validated by Kostakoğlu et al. In this scale (PANSS: Positive and Negative Syndrome Scale), as the score increases, symptoms/psychopathology become more severe. In other words, the higher the score, the greater the severity of symptoms and the greater the impairment in the patient's daily functioning.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Psychiatric Disorders, run by Koç University.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba ŞAHİN TOKATLIOĞLU, Dr. (+90539 474 87 07, tugbasahin@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young Mania Rating Scale (YMRS) (time frame: Before and after each therapy session (daily assessments during the 5-day intervention week for each group). Each group receives one week of therapy; in total, three groups will complete the intervention over three consecutive weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.