- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199817
The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Schizophrenia
The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Patients With Schizophrenia: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- have a physical health problem that prevents participation in the research
- Having a communication problem
- not willing to participate in research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
music, garden-soil and sports practices for individuals diagnosed with schizophrenic disorder
|
|
No Intervention: Control Group
The control group was informed about the research.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 month
|
|
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 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Remission of General Schzophrenia Scale (Post Test)
Time Frame: Forth 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.
"Functional Remission of General Schzophrenia Scale" score was expected to increase in the post test.
|
Forth month
|
|
Subjective Recovery Assessment Scale (Post Test)
Time Frame: Forth 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.
It was expected that the score obtained from the scale in the post-test would be high.
|
Forth month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Remission of General Schzophrenia Scale (Follow Up Test)
Time Frame: Seventh 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.
"Functional Remission of General Schzophrenia Scale" score was expected to increase in the follow up test.
|
Seventh month
|
|
Subjective Recovery Assessment Scale (Follow Up Test)
Time Frame: Seventh 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.
It was expected that the score obtained from the scale in the follow-up test would be high.
|
Seventh month
|
|
Effect Size of Functional Remission of General Schzophrenia Scale
Time Frame: Seventh month
|
It shows how the applied occupational therapies affect the final and follow-up test scale scores of the intervention and control groups in terms of time.
|
Seventh month
|
|
Effect Size of Subjective Recovery Assessment Scale
Time Frame: Seventh month
|
It shows how the applied occupational therapies affect the final and follow-up test scale scores of the intervention and control groups in terms of time.
|
Seventh month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aysegul Donmez, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-5.1/7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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