NCT07378150

Brief Summary

In recent years, art therapies have been discussed for their positive effects on mental disorders. One such therapy, clay therapy, is being studied to examine its effect on the functional recovery and individual and social performance of schizophrenia patients undergoing pharmacological treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

August 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

August 26, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

schizophreniaclay therapyFunctional RecoveryIndividual and Social Performanceart therapy

Outcome Measures

Primary Outcomes (1)

  • Functional Recovery Scale for Schizophrenia Patients

    This is a 5-point Likert-type scale consisting of 19 items that assesses improvements in functionality independent of the symptoms of the disease. Level 1 (absent) indicates the lowest level of improvement, while Level 5 (present to a high degree) corresponds to the 'ideal' level of function. Level 2 (partially present), Level 3 (sufficiently present) and Level 4 (almost completely present) are also included. When two levels are between, the lower level is selected. The maximum score that can be obtained from the scale is 95, and the minimum score is 19. The scale, which consists of subscales for daily living skills, social functioning, and health and treatment, measures functional improvement in three separate areas.

    12 weeks

Secondary Outcomes (1)

  • Individual and Social Performance Scale

    12 weeks

Study Arms (2)

Clay therapy group

EXPERIMENTAL

The experimental group will receive clay therapy sessions in addition to routine therapies.

Other: Clay therapy

Routine treatment group

NO INTERVENTION

Routine therapies will continue to be administered to the control group, but clay therapy will not be administered.

Interventions

Experimental: Clay therapy group

Clay therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with schizophrenia,
  • Being aged 18 or over,
  • Having completed at least primary school education,
  • Having achieved treatment compliance,
  • Currently undergoing pharmacological treatment,
  • Being in remission,
  • Having attended the Community Mental Health Centre regularly over the past year,
  • Having agreed to participate in the study
  • Scoring 20 points or higher on the Mini Mental State Examination

You may not qualify if:

  • Being under 18 years of age,
  • Not having an education,
  • Not having a diagnosis of schizophrenia,
  • Not adhering to treatment,
  • Not taking pharmacological treatment regularly,
  • Being in an acute attack/active phase,
  • Lacking insight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Utas-Akhan, L.., Avci, D., Basak, I. 2024. "Art Therapy as a nursing intervention for individuals with schizophrenia", Journal of Psychosocial Nursing and Mental Health Services, 62(5), 29-38. https://doi.org/10.3928/02793695-20231025-02

    BACKGROUND
  • Cataldas, S. K., Eren, N., Üstün, N., Ofluoğlu, F., Ayhan, C. H. 2025. "Effects of art therapy on quality of life and social functioning in individuals with schizophrenia", Journal of Psychosocial Nursing and Mental Health Services, 0(0), 1-7. https://doi.org/10.3928/02793695-20250107-02

    BACKGROUND
  • Ursuliak Z, Hughes J, Crocker CE, MacKenzie A, Tibbo PG. Claymation art therapy in early phase psychosis: A qualitative study to explore participants' experiences with the program and identify outcome effects. Early Interv Psychiatry. 2020 Dec;14(6):698-704. doi: 10.1111/eip.12896. Epub 2019 Nov 6.

    PMID: 31692270BACKGROUND
  • Taksal A, Sudhir PM, Janakiprasad KK, Viswanath D, Thirthalli J. Feasibility and effectiveness of the Integrated Psychological Therapy (IPT) in patients with schizophrenia: a preliminary investigation from India. Asian J Psychiatr. 2015 Oct;17:78-84. doi: 10.1016/j.ajp.2015.06.013. Epub 2015 Jul 30.

    PMID: 26277224BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
While the conventional treatment group continues to receive routine treatment, the experimental group will receive clay therapy sessions in addition to treatment, and the outcome assessments will be conducted by a researcher who is unaware of the group distribution.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 26, 2025

First Posted

January 30, 2026

Study Start

December 1, 2025

Primary Completion

January 9, 2026

Study Completion

February 20, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations