SchizophreniaNCT05901922
The Effect of Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia
A study testing Social skills training in people with Schizophrenia, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Social skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2023to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being an individual with a diagnosis of schizophrenia registered with the Community Mental Health Center
- Volunteering for the study and having written consent
Who cannot join
- Be under the age of 18 or over the age of 65
- Having a physical disability that limits participation in group activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Social skills training
- Keywords
- schizophrenia, Social Skills, Apraxia, Motor, Social Functioning
- Medical subject headings
- Schizophrenia, Social Skills, Apraxias, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Social skills training |
| control group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start7 Mar 2023
- Primary completion10 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatıma Zehra DOĞAN, Nigde Omer Halisdemir University
- Investigators
- Etem Erdal Erşan, professor, Study director, Niğde Ömer Halisdemir UniversityOnur Altuntaş, associate professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901922
- Sponsor's protocol ID
- NigdeOHU.OT
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Activity-Focused Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia
- ClinicalTrials.gov ID
- NCT05901922
- Acronym / sponsor ID
- NigdeOHU.OT
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Social Skills, Apraxia, Motor, Social Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Social skills trainingSocial 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. |
| control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being an individual with a diagnosis of schizophrenia registered with the Community Mental Health Center
- Volunteering for the study and having written consent
Key exclusion criteria (2 listed)
- Be under the age of 18 or over the age of 65
- Having a physical disability that limits participation in group activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social skills trainingIn 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. | Behavioural | intervention group |
Primary outcome
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.
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 secondary outcomes
The effect of social skills training on schizophrenia positive symptoms in individuals with schizophrenia
Time frame: 2 months
The effect of social skills training on schizophrenia negative symptoms in individuals with schizophrenia
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etem Erdal Erşan, professor study director
Niğde Ömer Halisdemir University
Onur Altuntaş, associate professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social skills training in people with Schizophrenia, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of social skills training on praxis in patients with schizophrenia was evaluated with TULIA (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.