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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Social skills training
Sponsored by
Nigde Omer Halisdemir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Social Skills, Apraxia, Motor, Social Functioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Niğde Ömer Halisdemir UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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.

No intervention.

Outcomes

Primary Outcome Measures

The effect of social skills training on praxis in patients with schizophrenia was evaluated with TULIA
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.
The effect of social skills training on social functionality in individuals with schizophrenia
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.

Secondary Outcome Measures

The effect of social skills training on schizophrenia positive symptoms in individuals with schizophrenia
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.
The effect of social skills training on schizophrenia negative symptoms in individuals with schizophrenia
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.

Full Information

First Posted
April 26, 2023
Last Updated
June 9, 2023
Sponsor
Nigde Omer Halisdemir University
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1. Study Identification

Unique Protocol Identification Number
NCT05901922
Brief Title
The Effect of Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia
Official Title
The Effect of Activity-Focused Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nigde Omer Halisdemir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, Social Skills, Apraxia, Motor, Social Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups, an application and a control group, will be used. Social skills training will be applied to one of the two groups with schizophrenia and not to the other group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Social skills training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of social skills training on praxis in patients with schizophrenia was evaluated with TULIA
Description
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.
Time Frame
2 months
Title
The effect of social skills training on social functionality in individuals with schizophrenia
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The effect of social skills training on schizophrenia positive symptoms in individuals with schizophrenia
Description
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.
Time Frame
2 months
Title
The effect of social skills training on schizophrenia negative symptoms in individuals with schizophrenia
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatıma Zehra Doğan, lecturer
Phone
05066320804
Email
zehradogn80@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia Çoban, psychologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etem Erdal Erşan, professor
Organizational Affiliation
Niğde Ömer Halisdemir University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Onur Altuntaş, associate professor
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Niğde Ömer Halisdemir University
City
Niğde
State/Province
Bor
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Çoban, psychologist
First Name & Middle Initial & Last Name & Degree
Etem Erdal Erşan, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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

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