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The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers

Primary Purpose

Schizophrenia, Caregiver, Psychoeducation

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Communication skills psychoeducation
General psychoeducation
Sponsored by
ŞİRİN HARKİN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The patient receiving care has a diagnosis of schizophrenia,
  • Living with the patient receiving care for 6 months,
  • Being directly (full) responsible for the care of the patient being cared for,
  • Be over 18 years old,
  • Living in the city center of Zonguldak,
  • To be at least primary school graduate,
  • Having no hearing and comprehension problems,

Exclusion Criteria:

• Having a history of substance abuse (excluding nicotine)

Sites / Locations

  • Zonguldak Bulent Ecevit University Health Practice and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

communication skills psychoeducation

general psychoeducation

Arm Description

Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months.

Communication skills focused psychoeducation 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.Session groups will be formed from a single session of 60-90 minutes for each topic.

General psychoeducation 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.

Outcomes

Primary Outcome Measures

The change of the "subjective well-being scale" score averages of the participants in the communication skills psychoeducation group before and after the training
After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale scores of the participants will increase. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after training. 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. Quantitative data will be used to measure the change in participants' views and feelings before and after the training. The data will be analyzed using the Statistical Package for Social Sciences package program.
The change of the "subjective well-being scale" mean scores of the participants in the communication skills psychoeducation group after the training compared to the mean scores of the control group participants
After the training, the difference in the "subjective well-being scale" score averages of the communication skills psychoeducation and control group participants will be examined.After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale mean scores of the participants will increase compared to the control group.Control group participants will not receive any intervention. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. 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.
The change of the "subjective well-being scale" score averages of the communication skills focused psychoeducation group participants after the training compared to the general psychoeducation group participants' mean scores
After the training, the difference between the subjective well-being scale scores of the participants in the communication skills psychoeducation group and the scores of the participants in the general psychoeducation group will be examined. It is expected that the mean scores of the communication skills psychoeducation group will be higher than the general psychoeducation group. An 8-week training program will be applied to the communication skills focused psychoeducation group, and a general psychoeducation program will be applied to the general psychoeducation group. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. 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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2021
Last Updated
September 24, 2021
Sponsor
ŞİRİN HARKİN
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1. Study Identification

Unique Protocol Identification Number
NCT05068765
Brief Title
The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers
Official Title
The Effect of Communication Skills Focused Psychoeducation on Subjective Well-Being of the Caregivers of Individual With the Diagnosis of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ŞİRİN HARKİN

4. Oversight

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

5. Study Description

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 88.5% 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Caregiver, Psychoeducation, Communication Skills, Well-being

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months.
Arm Title
communication skills psychoeducation
Arm Type
Experimental
Arm Description
Communication skills focused psychoeducation 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.Session groups will be formed from a single session of 60-90 minutes for each topic.
Arm Title
general psychoeducation
Arm Type
Experimental
Arm Description
General psychoeducation 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.
Intervention Type
Other
Intervention Name(s)
Communication skills psychoeducation
Intervention Description
Intervention explanations are explained in the groups section.
Intervention Type
Other
Intervention Name(s)
General psychoeducation
Intervention Description
İntervention descriptions are explained in the intervention groups section.
Primary Outcome Measure Information:
Title
The change of the "subjective well-being scale" score averages of the participants in the communication skills psychoeducation group before and after the training
Description
After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale scores of the participants will increase. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after training. 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. Quantitative data will be used to measure the change in participants' views and feelings before and after the training. The data will be analyzed using the Statistical Package for Social Sciences package program.
Time Frame
12 months
Title
The change of the "subjective well-being scale" mean scores of the participants in the communication skills psychoeducation group after the training compared to the mean scores of the control group participants
Description
After the training, the difference in the "subjective well-being scale" score averages of the communication skills psychoeducation and control group participants will be examined.After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale mean scores of the participants will increase compared to the control group.Control group participants will not receive any intervention. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. 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.
Time Frame
12 months
Title
The change of the "subjective well-being scale" score averages of the communication skills focused psychoeducation group participants after the training compared to the general psychoeducation group participants' mean scores
Description
After the training, the difference between the subjective well-being scale scores of the participants in the communication skills psychoeducation group and the scores of the participants in the general psychoeducation group will be examined. It is expected that the mean scores of the communication skills psychoeducation group will be higher than the general psychoeducation group. An 8-week training program will be applied to the communication skills focused psychoeducation group, and a general psychoeducation program will be applied to the general psychoeducation group. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. 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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patient receiving care has a diagnosis of schizophrenia, Living with the patient receiving care for 6 months, Being directly (full) responsible for the care of the patient being cared for, Be over 18 years old, Living in the city center of Zonguldak, To be at least primary school graduate, Having no hearing and comprehension problems, Exclusion Criteria: • Having a history of substance abuse (excluding nicotine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hülya Bilgin, Prof.
Organizational Affiliation
Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty Mental Health and Psychiatric Nursing Department
Official's Role
Study Director
Facility Information:
Facility Name
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD.
IPD Sharing Time Frame
12 months
Citations:
PubMed Identifier
29587690
Citation
Gharavi Y, Stringer B, Hoogendoorn A, Boogaarts J, Van Raaij B, Van Meijel B. Evaluation of an interaction-skills training for reducing the burden of family caregivers of patients with severe mental illness: a pre-posttest design. BMC Psychiatry. 2018 Mar 27;18(1):84. doi: 10.1186/s12888-018-1669-z.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.ejpsy.2018.04.001
Description
Rezaei, et al. (2018). Applying psychoeducational program on general health and communication skills in caregivers of patients with schizophrenia: a randomized controlled trial. The European Journal of Psychiatry, 32(4), 174-181

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The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers

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