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The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients

Primary Purpose

Schizophrenia

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive behavioral approach based resilience development program for schizophrenic individuals
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia, Development resilience, Resilience, Functionality, Cognitive behavioral

Eligibility Criteria

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

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

Sites / Locations

  • Nisantası Community Mental Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

Cognitive behavioral approach based resilience development program

Outcomes

Primary Outcome Measures

Resilience level
High resilience score

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
February 18, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Collaborators
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT05739344
Brief Title
The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients
Official Title
The Effect of the Cognitive Behavioral Therapy - Based Resilience Development Program Applied to Schizophrenia Patients on Resilience and Functionality
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Collaborators
Uskudar University

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Development resilience, Resilience, Functionality, Cognitive behavioral

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Cognitive behavioral approach based resilience development program
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral approach based resilience development program for schizophrenic individuals
Intervention Description
The intervention will be administered as sessions of 2 hours once a week.
Primary Outcome Measure Information:
Title
Resilience level
Description
High resilience score
Time Frame
After 12 weeks

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begum Dag
Organizational Affiliation
Sisli Etfal Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nisantası Community Mental Health Center
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Developing Psychological Resilience on Functionality in Schizophrenia Patients

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