The Effect of Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia

February 1, 2024 updated by: Fatıma Zehra DOĞAN, Nigde Omer Halisdemir University

The Effect of Activity-Focused Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia

This study will be carried out with individuals diagnosed with schizophrenia who continue to community mental health. Social skills training will be applied in the study. This study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia.

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

This study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia. Test of Upper Limb Apraxia (TULIA) will be used for praxis assessment. Social Functioning Assessment Scale (SFAS) will be used for social functioning assessment. In this study, individuals with schizophrenia will be examined with the Model of Creativity Ability as an occupational therapy model and role playing activities will be determined according to the model. In secondary outcomes, the effect of social skills training on the symptoms of schizophrenia will be examined. therefore Scale for the Assessment of Positive Symptoms - SAPS and Scale for the Assessment of Negative Symptoms - SANS will be used in the study.

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.
24

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Rabia Çoban, psychologist

Study Locations

  • Turkey
    • Bor
      • Niğde, Bor, Turkey
        • Nigde Omer Halisdemir University

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 an individual with a diagnosis of schizophrenia registered with the Community Mental Health Center
  • Volunteering for the study and having written consent

Exclusion Criteria:

  • Be under the age of 18 or over the age of 65
  • Having a physical disability that limits participation in group activities

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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
Social skills training will be applied to this group. social skills training will be applied for 10 sessions. Sessions will be 2 sessions per week. Session duration will be 1 hour.
Behavioral: Social skills training
In this training, role-playing will be done in groups of six. In these role playing, the importance and application of the social skill specified before the session will be studied.
No Intervention: control group
No intervention.

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
The effect of social skills training on praxis in patients with schizophrenia was evaluated with TULIA
Time Frame: 2 months
Test of Upper Limb Apraxia- TULIA: TULIA is a short-term apraxia test. TULIA was developed for the evaluation of hand movements (gestures) with and without symbolic meaning. Those that have symbolic value are also gestures associated with communication and also with the use of objects/tools. These three areas are evaluated as imitation (imitation) and pantomime ("pretending-following verbal instructions") examination by following the practitioner. Thus, TULIA, which consists of 6 subtests, consists of 48 items in the form of 8 items in each subtest. The 6-point scoring method (0-5) is used to calculate the result (range 0-240). A higher score means a better result in this assessment test. The test has Turkish validity.
2 months
The effect of social skills training on social functionality in individuals with schizophrenia
Time Frame: 2 months
Social Functioning Evaluation Scale:This scale, which was developed in Turkey, evaluates social functioning in schizophrenia patients with 19 items and four sub-dimensions. Among the factors, interpersonal relations and entertainment consist of seven items, self-care consists of seven items, independent living skills consist of four items and work life consists of one item. The score that can be obtained from the scale is between 19 and 57, and a high score means a high level of social functionality.
2 months

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
The effect of social skills training on schizophrenia positive symptoms in individuals with schizophrenia
Time Frame: 2 months

Scale for the Assessment of Positive Symptoms - SAPS:

The scale evaluates the level, distribution and severity of positive symptoms of patients with schizophrenia. The reliability of the Turkish form was made. It is a scale that has 4 subscales and includes 34 items. The subscales are hallucinations, delusions, strange behavior, and formal thought disorder. The scoring of each item varies between 0-5. The total score varies between 0-170. A lower score means a better result on this assessment test.
2 months
The effect of social skills training on schizophrenia negative symptoms in individuals with schizophrenia
Time Frame: 2 months

Scale for the Assessment of Negative Symptoms - SANS:

The scale evaluates the level, distribution and severity of negative symptoms of patients with schizophrenia. The reliability of the Turkish form was made. Has 5 subscales and includes 25 items. Subscales are affective blunting, alogy, apathy, anhedonia, and attention deficit. The scoring of each item varies from 0 to 25.The total score ranges from 0 to 125. A lower score means a better result on this assessment test.
2 months

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.
Nigde Omer Halisdemir 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: Etem Erdal Erşan, professor, Nigde Omer Halisdemir University
  • Study Director: Onur Altuntaş, associate professor, Hacettepe 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.
March 7, 2023

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.
June 10, 2023

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.
July 15, 2023

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).
April 26, 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.
June 9, 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.
June 13, 2023

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 2, 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 1, 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.
February 1, 2024

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.
  • NigdeOHU.OT

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.

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