NCT05901922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

April 26, 2023

Last Update Submit

February 1, 2024

Conditions

Keywords

schizophreniaSocial SkillsApraxia, MotorSocial Functioning

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 months

  • 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.

    2 months

Secondary Outcomes (2)

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

    2 months

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

    2 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

No intervention.

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University

Niğde, Bor, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SchizophreniaSocial SkillsApraxiasSocial Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehaviorPsychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Etem Erdal Erşan, professor

    Niğde Ömer Halisdemir University

    STUDY DIRECTOR
  • Onur Altuntaş, associate professor

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 26, 2023

First Posted

June 13, 2023

Study Start

March 7, 2023

Primary Completion

June 10, 2023

Study Completion

July 15, 2023

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations