Schizophrenia and Related DisordersNCT07378150
Clay Therapy in Schizophrenia Patients
A study testing Clay therapy in people with Schizophrenia and Related Disorders, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- Clay therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 23 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Clay Therapy on Functional Improvement and Individual and Social Performance in Schizophrenic Patients
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.
Read the detailed description
Schizophrenia is a chronic illness that can manifest in various forms, ranging from symptoms such as delusions and hallucinations to functional impairments, and is often characterised by relapses.
The care of people with schizophrenia concerns all sectors of society, including families, healthcare professionals, and organisations providing psychosocial support. The treatment of schizophrenia is of great importance due to its potential for early onset and its status as one of the most common psychiatric disorders leading to functional impairment.
While pharmacological treatments support a large part of the treatment process, the effect of art therapy on preventing disability and treatment compliance and disease awareness is the subject of current studies. Clay therapy, a component of art therapy, has been used in the treatment of psychiatric disorders, especially in recent years. Studies have highlighted the therapeutic aspects of clay. When examining the therapeutic properties of clay, it is seen to provide benefits in the following areas:
- Facilitating the expression of emotions,
- Bringing unconscious material to the surface,
- Facilitating rich and deep expression,
- Facilitating verbal communication,
- Concretisation and symbolisation. This study aims to examine the effect of clay therapy on the functional recovery and individual and social performance of schizophrenia patients.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- Clay therapy
- Keywords
- schizophrenia, clay therapy, Functional Recovery, Individual and Social Performance, art therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clay therapyOther
Experimental: Clay therapy group
| Study group | Role | What they receive |
|---|---|---|
| Clay therapy group | Experimental | The experimental group will receive clay therapy sessions in addition to routine therapies. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Individual and Social Performance Scale
This scale, scored from 1 to 100, is conducted in three stages. In the first stage, the level of functionality is determined through a sequential assessment across four dimensions: socially beneficial activities, individual and social relationships, self-care, and disruptive and aggressive behaviours. After each dimension is assessed, it is scored between 0 and 10 points based on the degree of impairment in that dimension.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Dec 2025
- Primary completion5 Dec 2025
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a conventional therapy control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Karabulut, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378150
- Sponsor's protocol ID
- KSHU-SBF-EK-01
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Utas-Akhan L, Avci D, Basak I. Art Therapy as a Nursing Intervention for Individuals With Schizophrenia. J Psychosoc Nurs Ment Health Serv. 2024 May;62(5):29-38. doi: 10.3928/02793695-20231025-02. Epub 2023 Nov 13.
PubMed 37956349Cataldas SK, Eren N, Ustun N, Ofluoglu F, Ayhan CH. Effects of Art Therapy on Quality of Life and Social Functioning in Individuals With Schizophrenia. J Psychosoc Nurs Ment Health Serv. 2025 May;63(5):49-55. doi: 10.3928/02793695-20250107-02. Epub 2025 Jan 15.
PubMed 39808488Ursuliak 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.
PubMed 31692270Taksal 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.
PubMed 26277224
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clay Therapy on Functional Improvement and Individual and Social Performance in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT07378150
- Acronym / sponsor ID
- KSHU-SBF-EK-01
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- schizophrenia, clay therapy, Functional Recovery, Individual and Social Performance, art therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 30 Jan 2026 (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.
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.
Detailed description
Schizophrenia is a chronic illness that can manifest in various forms, ranging from symptoms such as delusions and hallucinations to functional impairments, and is often characterised by relapses.
The care of people with schizophrenia concerns all sectors of society, including families, healthcare professionals, and organisations providing psychosocial support. The treatment of schizophrenia is of great importance due to its potential for early onset and its status as one of the most common psychiatric disorders leading to functional impairment.
While pharmacological treatments support a large part of the treatment process, the effect of art therapy on preventing disability and treatment compliance and disease awareness is the subject of current studies. Clay therapy, a component of art therapy, has been used in the treatment of psychiatric disorders, especially in recent years. Studies have highlighted the therapeutic aspects of clay. When examining the therapeutic properties of clay, it is seen to provide benefits in the following areas:
- Facilitating the expression of emotions,
- Bringing unconscious material to the surface,
- Facilitating rich and deep expression,
- Facilitating verbal communication,
- Concretisation and symbolisation. This study aims to examine the effect of clay therapy on the functional recovery and individual and social performance of schizophrenia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Clay therapy group | Experimental | Other: Clay therapyThe experimental group will receive clay therapy sessions in addition to routine therapies. |
| Routine treatment group | No intervention | –Routine therapies will continue to be administered to the control group, but clay therapy will not be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Clay therapyExperimental: Clay therapy group | Other | Clay therapy group |
Primary outcome
Functional Recovery Scale for Schizophrenia Patients
Time frame: 8 weeks
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.
1 secondary outcome
Individual and Social Performance Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 37956349Utas-Akhan L, Avci D, Basak I. Art Therapy as a Nursing Intervention for Individuals With Schizophrenia. J Psychosoc Nurs Ment Health Serv. 2024 May;62(5):29-38. doi: 10.3928/02793695-20231025-02. Epub 2023 Nov 13.
- Background: PubMed 39808488Cataldas SK, Eren N, Ustun N, Ofluoglu F, Ayhan CH. Effects of Art Therapy on Quality of Life and Social Functioning in Individuals With Schizophrenia. J Psychosoc Nurs Ment Health Serv. 2025 May;63(5):49-55. doi: 10.3928/02793695-20250107-02. Epub 2025 Jan 15.
- Background: PubMed 31692270Ursuliak 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.
- Background: PubMed 26277224Taksal 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clay therapy in people with Schizophrenia and Related Disorders, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery Scale for Schizophrenia Patients (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07378150, which also lists 4 linked publications.
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 28 Jul 2026.