SchizophreniaNCT05739344
The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients
A study testing Cognitive behavioral approach based resilience development program for schizophrenic individuals in people with Schizophrenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
People with schizophrenia have low functionality and psychological resilience. Psychological resilience of individuals can be improved. The funcionality of individual with improved psychological resilience can also be improved. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive behavioral approach based resilience development program for schizophrenic individuals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Mar 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
- Be at least literate
- Be in remision
- Not have mental retardation, hearing and speech problem
Who cannot join
- Those in acute exacerbation
- Those with other psychiatric illnesses
- Those who are / have attended a similar training program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nisantası Community Mental Health Center
Istanbul, 34365
About this study
Official title: The Effect of the Cognitive Behavioral Therapy - Based Resilience Development Program Applied to Schizophrenia Patients on Resilience and Functionality
People with schizophrenia have low functionality and psychological resilience. Psychological resilience of individuals can be improved. The funcionality of individual with improved psychological resilience can also be improved. Therefore, both resilience and functionality can be increased by appliying resilience programs to patients with schizophrenia.
Read the detailed description
The aim of study is to determine the effect of the resilience development program applied to schizophrenia patients on the resilience and functionality of the patients. Experimental research design with pretest posttest control group will be used in the study. 36 patients receiving service from a community mental health center will be included in the study (determined by "power analysis"). 18 people will be included in the experimental group and 18 people in the control group (Random appointment will be made by drawing lots). The data of the study will bu collected with "Personal Information Form", "Adult Resilience Scale", "Short Functionality Assessment Scale" and "Beck Cognitive Insight Scale - for Schizophrenic Patients". Consent will be obtained from the individuals participating in the study before the study. An "ethics commitee approval certificate" will also be obtained before starting the study. "Resilience Development Program" based on cognitive behavioral approach developed by the researcher will be applied to the experimental group. SPSS 28.0 program will be used in the analysis of the data. Mean, standard deviation, median, minimum and maximum values will be used in the descriptive statistics of the data. Mann whitney u test, chi-square test and wilcoxon test will be used in the analysis of quantitative independent data.
- Conditions
- Schizophrenia
- Being tested
- Cognitive behavioral approach based resilience development program for schizophrenic individuals
- Keywords
- Schizophrenia, Development resilience, Resilience, Functionality, Cognitive behavioral
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral approach based resilience development program for schizophrenic individualsBehavioural
The intervention will be administered as sessions of 2 hours once a week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Cognitive behavioral approach based resilience development program Receives: Behavioral: Cognitive behavioral approach based resilience development program for schizophrenic individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience level
High resilience score
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2022
- Primary completion28 Feb 2023
- Study completion1 Mar 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Begüm Dag, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Begum Dag, Principal investigator, Sisli Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739344
- Sponsor's protocol ID
- Begüm Dağ
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Cognitive Behavioral Therapy - Based Resilience Development Program Applied to Schizophrenia Patients on Resilience and Functionality
- ClinicalTrials.gov ID
- NCT05739344
- Acronym / sponsor ID
- Begüm Dağ
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Development resilience, Resilience, Functionality, Cognitive behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 22 Feb 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.
People with schizophrenia have low functionality and psychological resilience. Psychological resilience of individuals can be improved. The funcionality of individual with improved psychological resilience can also be improved. Therefore, both resilience and functionality can be increased by appliying resilience programs to patients with schizophrenia.
Detailed description
The aim of study is to determine the effect of the resilience development program applied to schizophrenia patients on the resilience and functionality of the patients. Experimental research design with pretest posttest control group will be used in the study. 36 patients receiving service from a community mental health center will be included in the study (determined by "power analysis"). 18 people will be included in the experimental group and 18 people in the control group (Random appointment will be made by drawing lots). The data of the study will bu collected with "Personal Information Form", "Adult Resilience Scale", "Short Functionality Assessment Scale" and "Beck Cognitive Insight Scale - for Schizophrenic Patients". Consent will be obtained from the individuals participating in the study before the study. An "ethics commitee approval certificate" will also be obtained before starting the study. "Resilience Development Program" based on cognitive behavioral approach developed by the researcher will be applied to the experimental group. SPSS 28.0 program will be used in the analysis of the data. Mean, standard deviation, median, minimum and maximum values will be used in the descriptive statistics of the data. Mann whitney u test, chi-square test and wilcoxon test will be used in the analysis of quantitative independent data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Cognitive behavioral approach based resilience development program for schizophrenic individualsCognitive behavioral approach based resilience development program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least literate
- Be in remision
- Not have mental retardation, hearing and speech problem
Key exclusion criteria (3 listed)
- Those in acute exacerbation
- Those with other psychiatric illnesses
- Those who are / have attended a similar training program
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 |
|---|---|---|
| Cognitive behavioral approach based resilience development program for schizophrenic individualsThe intervention will be administered as sessions of 2 hours once a week. | Behavioural | Experimental Group |
Primary outcome
Resilience level
Time frame: After 12 weeks
High resilience score
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 23 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
Begum Dag principal investigator
Sisli Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral approach based resilience development program for schizophrenic individuals in people with Schizophrenia, run by Sisli Hamidiye Etfal Training and Research Hospital 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 3 inclusion and 3 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 23 Apr 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?
Resilience level (time frame: After 12 weeks). 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 23 Apr 2024.