Viewing Study NCT05068765



Ignite Creation Date: 2024-05-06 @ 4:41 PM
Last Modification Date: 2024-10-26 @ 2:15 PM
Study NCT ID: NCT05068765
Status: UNKNOWN
Last Update Posted: 2021-10-06
First Post: 2021-08-02

Brief Title: The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers
Sponsor: ŞİRİN HARKİN
Organization: Istanbul University - Cerrahpasa IUC

Study Overview

Official Title: The Effect of Communication Skills Focused Psychoeducation on Subjective Well-Being of the Caregivers of Individual With the Diagnosis of Schizophrenia
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to evaluate the effectiveness of a communication skills-focused psychoeducation program on the subjective well-being of primary caregivers of individuals with schizophrenia

Today with the adoption of contemporary treatment models the relatives of individuals with schizophrenia have become caregivers Some caregivers who are not competent enough to communicate satisfactorily with a person diagnosed with schizophrenia may have problems in patient-patient-relative interaction Problems that occur frequently in expressing oneself giving appropriate reactions in interaction with the patient and creating a sense of trust are seen as a major source of concern by caregivers In the solution of this problem improving the communication skills of the caregiver and increasing the self-confidence and motivation to communicate with the individual diagnosed with schizophrenia is an area that should be addressed by mental health professionals

By using a communication skills focused psychoeducation program it is aimed to increase the level of subjective well-being of caregivers of individuals with schizophrenia by establishing healthy and positive relationships coping with the negative emotions and difficulties they face realizing their strengths and leading a happy and meaningful life Within the scope of this aim it was aimed to evaluate the effect of a communication skills focused psychoeducation program on the subjective well-being of caregivers of individuals with schizophrenia
Detailed Description: This study was planned as an experimental study with a randomized control group in order to evaluate the effect of psychoeducation focused on communication skills on the subjective well-being of caregivers of individuals with schizophrenia

The population of the research will be family members who apply to ZBEÜ Application and Research Center Psychiatry Outpatient Clinic and care for individuals diagnosed with schizophrenia according to DSM-5 TR criteria Statistical power analysis was applied for the number of samples While calculating the power values the results were determined within the scope of 95 confidence level According to the power values obtained from the reference study in parallel with the research to be carried out if this study is studied with a total of 60 observations a test power of approximately 885 is reached As a result according to the power analysis it was determined that the research could be done with 60 observations The caregiver family members included in the study will be stratified according to the scores they get from the care burden and communication skills scale and some individual characteristics and an equal number of individuals from each stratum will be selected and they will be included in two intervention groups and a control group by randomization

The Criteria for Inclusion of Caregivers in the Research are as follows

The patient receiving care should have been diagnosed with schizophrenia at least one year ago according to the DSM-V TR diagnostic criteria
Living together with the caregiver for at least six months
Being directly fully responsible for the care of the patient being cared for
Being 18 years or older
Residing in the city center of Zonguldak
To be at least primary school graduate
No hearing and comprehension problems The first measurements Information Form Zarit Care Burden Scale Subjective Well-Being Scale and Communication Skills Scale will be collected by making face-to-face preliminary interviews with the caregivers who meet the research criteria and agree to participate in the research

After the pre-test intervention and control groups will be formed in line with homogeneity in terms of scale scores and some individual characteristics

While the control group continues their routine follow-ups psychoeducation focused on communication skills will be applied to the first intervention group and general psychoeducation program to the second intervention group

After the psychoeducation program is completed final measurements will be collected for intervention and control groups Follow-up measurements will be made in the intervention and control groups in the 1st and 3rd months

The first intervention group will be given a communication skills-focused psychoeducation program for eight weeks one session per week for a total of eight sessions The number of sessions was planned with reference to the study in which the effect of the psychoeducation program on general health and communication skills in caregivers of individuals with schizophrenia was investigated The second intervention group will be given a general psychoeducation program for four weeks one session per week in total Session groups will be formed from a single session of 60-90 minutes for each topic

Scales Subjective well-being scale The scale is a five-point Likert type consisting of 46 items The aim of the scale is to determine the subjective well-being levels of individuals by determining the frequency and intensity of positive and negative emotions with their cognitive evaluations of their lives Subjective well-being scale consists of personal judgments and positive and negative emotional expressions about living spaces The lowest score that can be obtained from the scale is 46 and the highest score is 230 A high score indicates a high level of subjective well-being

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None