The Effect Of Multiple Occupational Therapies On Functional Remission And Subjective Recovery For Schizophrenia

February 2, 2024 updated by: Merve Uğuryol Ünal, Ege University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: occupational therapies
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Aysegul Donmez, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-5.1/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Schizophrenia

Clinical Trials on occupational therapies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings