- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739344
The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients
April 22, 2024 updated by: Begüm Dag, Sisli Hamidiye Etfal Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
13
Phase
- 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 Locations
-
-
-
Istanbul, Turkey, 34365
- Nisantası Community Mental Health Center
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be at least literate
- Be in remision
- Not have mental retardation, hearing and speech problem
Exclusion Criteria:
- Those in acute exacerbation
- Those with other psychiatric illnesses
- Those who are / have attended a similar training program
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Cognitive behavioral approach based resilience development program
|
The intervention will be administered as sessions of 2 hours once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience level
Time Frame: After 12 weeks
|
High resilience score
|
After 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Begum Dag, Sisli Etfal Training and Research Hospital
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)
February 1, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
February 5, 2023
First Submitted That Met QC Criteria
February 18, 2023
First Posted (Actual)
February 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Begüm Dağ
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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