The Effect of Art Therapy on Disease Severity and Anxiety Levels in Inpatients at a Psychiatry Clinic

NCT07162428 | Not Yet Recruiting DMC

• 1 other identifier: tugbasahin
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Psychiatric Disorders

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Before and after each session across the 5-day intervention week for each group (three groups in total, over three weeks).

Study Arms (2)

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.

Behavioral: Art Therapy

Control Group (Standard Care)

NO INTERVENTION

Participants in this group will receive standard psychiatric care without additional art therapy sessions.

Interventions

Art Therapy BEHAVIORAL

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.

Art Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Tuğba ŞAHİN TOKATLIOĞLU, Dr.

CONTACT

+90539 474 87 07; tugbasahin@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; neither participants nor investigators are blinded to the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the art therapy intervention group or the control group receiving standard care

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: September 15, 2025
• Primary Completion: September 16, 2025
• Study Completion: November 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share