SchizophreniaNCT05068765
The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers
A study testing Communication skills psychoeducation and General psychoeducation in people with Schizophrenia and Caregiver, run by ŞİRİN HARKİN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Caregiver, Psychoeducation
- What is being tested?
- Communication skills psychoeducation and General psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 30 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- Having a history of substance abuse (excluding nicotine)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
Zonguldak
About this study
Official title: The Effect of Communication Skills Focused Psychoeducation on Subjective Well-Being of the Caregivers of Individual With the Diagnosis of Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia, Caregiver, Psychoeducation, Communication Skills, Well-being
- Being tested
- Communication skills psychoeducation, General psychoeducation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication skills psychoeducationOther
Intervention explanations are explained in the groups section.
General psychoeducationOther
İntervention descriptions are explained in the intervention groups section.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months. |
| communication skills psychoeducation | Experimental | 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. Receives: Other: Communication skills psychoeducation |
| general psychoeducation | Experimental | 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. Receives: Other: General psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ŞİRİN HARKİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ŞİRİN HARKİN, Istanbul University - Cerrahpasa
- Investigators
- Hülya Bilgin, Prof., Study director, Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty Mental Health and Psychiatric Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068765
- Sponsor's protocol ID
- 157435
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD.
Publications
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.
PubMed 29587690Harkin S, Bilgin H. The effect of communication skills-focused psychoeducation on subjective well-being of caregivers of individuals with schizophrenia: a three-arm randomized controlled trial. BMC Psychiatry. 2026 Jul 24;26(1):697. doi: 10.1186/s12888-026-08413-2.
PubMed 42693442
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Communication Skills Focused Psychoeducation on Subjective Well-Being of the Caregivers of Individual With the Diagnosis of Schizophrenia
- ClinicalTrials.gov ID
- NCT05068765
- Acronym / sponsor ID
- 157435
- Conditions
- Schizophrenia, Caregiver, Psychoeducation, Communication Skills, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ŞİRİN HARKİNUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 Oct 2021 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months. |
| communication skills psychoeducation | Experimental | Other: Communication skills psychoeducationCommunication 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 | Experimental | Other: General psychoeducationGeneral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- Having a history of substance abuse (excluding nicotine)
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 |
|---|---|---|
| Communication skills psychoeducationIntervention explanations are explained in the groups section. | Other | communication skills psychoeducation |
| General psychoeducationİntervention descriptions are explained in the intervention groups section. | Other | general psychoeducation |
Primary outcome
The change of the "subjective well-being scale" score averages of the participants in the communication skills psychoeducation group before and after the training
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 29587690Gharavi 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.
- Derived from this study: PubMed 42693442Harkin S, Bilgin H. The effect of communication skills-focused psychoeducation on subjective well-being of caregivers of individuals with schizophrenia: a three-arm randomized controlled trial. BMC Psychiatry. 2026 Jul 24;26(1):697. doi: 10.1186/s12888-026-08413-2.
- 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), 174-181Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD.
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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.
Hülya Bilgin, Prof. study director
Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty Mental Health and Psychiatric Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication skills psychoeducation and General psychoeducation in people with Schizophrenia and Caregiver, run by ŞİRİN HARKİN 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. 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?
Results are not available in the source record.
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?
The change of the "subjective well-being scale" score averages of the participants in the communication skills psychoeducation group before and after the training (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068765, which also lists 2 linked publications.
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 6 Oct 2021.