Occupational TherapyNCT06199817
The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Schizophrenia
A study testing occupational therapies in people with Occupational Therapy and Schizophrenia, run by Ege University.
Trial summary
Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Occupational Therapy, Schizophrenia, Remission
- What is being tested?
- occupational therapies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 19 Aug 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the 18-65 age group
- have been diagnosed with schizophrenia for at least one year
- be in remission of the disease
- volunteering to participate in research
- not have any physical health problems that would prevent their participation in the research
Who cannot join
- have a physical health problem that prevents participation in the research
- Having a communication problem
- not willing to participate in research
About this study
Official title: The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Patients With Schizophrenia: A Randomized Controlled Trial
Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services.
Read the detailed description
Background: Occupational therapies are one of the psycho-social intervention methods used in the treatment of serious mental disorders characterized by disability, such as schizophrenia.
Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder.
Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services. Data were collected using the Subjective Recovery Assessment Scale and the Functional Remission of General Schizophrenia Scale.
- Being tested
- occupational therapies
- Keywords
- Shizophrenic Disorder, Occupational Therapy, Remission, Well-Being, Psychological
- Medical subject headings
- Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapiesBehavioural
music, garden-soil and sports practices for individuals diagnosed with schizophrenic disorder
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group was informed about the research. The intervention group consists of patients diagnosed with schizophrenic disorder. Music, sports and garden-soil activities were applied to the intervention group. Receives: Behavioral: occupational therapies |
| Control Group | No intervention | The control group was informed about the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Remission of General Schzophrenia Scale (Pre Test)
The scale is a 5-point Likert type scale consisting of 19 items. The minimum score obtained from the scale is 19 points and the maximum score is 95 points. High scores from the scale indicate high functionality, while low scores from the scale indicate low functionality. Scale scores were expected to be low in the pretest.
Measured: 2 month
Subjective Recovery Assessment Scale (Pre Test)
The scale is a 5-point Likert type consisting of 17 items. The lowest score from the scale is 17 and the highest score is 85. Higher scores from the scale indicate that the individual perceives himself as more improved. Scale scores were expected to be low in the pretest.
Measured: 2 month
Secondary outcomes (2)
Functional Remission of General Schzophrenia Scale (Post Test)
The scale is a 5-point Likert type scale consisting of 19 items. The minimum score obtained from the scale is 19 points and the maximum score is 95 points. High scores from the scale indicate high functionality, while low scores from the scale indicate low functionality. "Functional Remission of General Schzophrenia Scale" score was expected to increase in the post test.
Measured: Forth month
Subjective Recovery Assessment Scale (Post Test)
The scale is a 5-point Likert type consisting of 17 items. The lowest score from the scale is 17 and the highest score is 85. Higher scores from the scale indicate that the individual perceives himself as more improved. It was expected that the score obtained from the scale in the post-test would be high.
Measured: Forth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jun 2016
- Primary completion1 May 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational TherapyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Uğuryol Ünal, Ege University
- Investigators
- Aysegul Donmez, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199817
- Sponsor's protocol ID
- 16-5.1/7
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Patients With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06199817
- Acronym / sponsor ID
- 16-5.1/7
- Keywords
- Shizophrenic Disorder, Occupational Therapy, Remission, Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 10 Jan 2024 (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.
Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services.
Detailed description
Background: Occupational therapies are one of the psycho-social intervention methods used in the treatment of serious mental disorders characterized by disability, such as schizophrenia.
Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder.
Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services. Data were collected using the Subjective Recovery Assessment Scale and the Functional Remission of General Schizophrenia Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: occupational therapiesThe intervention group was informed about the research. The intervention group consists of patients diagnosed with schizophrenic disorder. Music, sports and garden-soil activities were applied to the intervention group. |
| Control Group | No intervention | –The control group was informed about the research. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being in the 18-65 age group
- have been diagnosed with schizophrenia for at least one year
- be in remission of the disease
- volunteering to participate in research
- not have any physical health problems that would prevent their participation in the research
Key exclusion criteria (3 listed)
- have a physical health problem that prevents participation in the research
- Having a communication problem
- not willing to participate in research
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 |
|---|---|---|
| occupational therapiesmusic, garden-soil and sports practices for individuals diagnosed with schizophrenic disorder | Behavioural | Intervention Group |
Primary outcome
Functional Remission of General Schzophrenia Scale (Pre Test)
Time frame: 2 month
The scale is a 5-point Likert type scale consisting of 19 items. The minimum score obtained from the scale is 19 points and the maximum score is 95 points. High scores from the scale indicate high functionality, while low scores from the scale indicate low functionality. Scale scores were expected to be low in the pretest.
Subjective Recovery Assessment Scale (Pre Test)
Time frame: 2 month
The scale is a 5-point Likert type consisting of 17 items. The lowest score from the scale is 17 and the highest score is 85. Higher scores from the scale indicate that the individual perceives himself as more improved. Scale scores were expected to be low in the pretest.
2 secondary outcomes
Functional Remission of General Schzophrenia Scale (Post Test)
Time frame: Forth month
Subjective Recovery Assessment Scale (Post Test)
Time frame: Forth month
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 6 Feb 2024.
- 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.
Aysegul Donmez study director
Ege University
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapies in people with Occupational Therapy and Schizophrenia, run by Ege 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 5 inclusion and 3 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 6 Feb 2024. 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?
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 Remission of General Schzophrenia Scale (Pre Test) (time frame: 2 month). The study lists 2 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 6 Feb 2024.