Chronic Mental DisorderNCT05074004
The Effect of Psychoeducation Given In Psychiatry Day Hospital
A study testing Psychoeducation in people with Chronic Mental Disorder and Psychoeducation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Background: Psychoeducation is a process used in the realization of the principles of treatment and rehabilitation of mental illnesses and aims to help the patient and his/her family outside the hospital, to help the patient cope with the problems, experiencing, and to support them to live productive lives in society. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Mental Disorder, Psychoeducation
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 15 May 2018
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who were followed up in the psychiatry day hospital,
- accepted to participate in the study,
- signed the informed consent form, and were able to read
Who cannot join
- individuals indicating their desire to leave the study,
- the development of an attack requiring hospitalization,
- not attending education for more than two sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Psychoeducation Given In Psychiatry Day Hospital on The Self-Sufficiency and Well-Being of The Patients
Background: Psychoeducation is a process used in the realization of the principles of treatment and rehabilitation of mental illnesses and aims to help the patient and his/her family outside the hospital, to help the patient cope with the problems, experiencing, and to support them to live productive lives in society.
Aims: This study aims to determine the effect of psychoeducation, given in a psychiatry dayhospital, on patients' self-sufficiency and well-being.
Read more
Methods: The research is a single-blind randomized controlled experimental study. The sample of the study consisted of 28 schizophrenic patient(14experiment-14control), who agreed to participate in the study, followed in XXX University Psychiatry Day Hospital. In the study, an 8-week psychoeducation program was applied to the experimental group, and no intervention was made tothe control group. Socio-demographic data form, self-sufficiency scale, and well-being scale were used as data collection tools. The data obtained were analyzed using theSPSS-23 package program.
Results: After the eight-week psychoeducation program, the pretest and posttest scores of the evaluations obtained from the scales of both groups were compared. It was found that while there was no change in thescores of the control group, there was an increase in the well-being and self-efficacy scores of the experimental group. While the increase in well-being was statistically significant(p<0.05), the increase in self-sufficiency score wasnot statistically significant(p>0.05), but the numerical increase was considered tobe aclinically significant result.
Read the detailed description
Mental illnesses cause deterioration in various areas of functionality such as personal care, family and social relations, communication, professional life, and leisure activities. Mental diseases that cause disability are common in society. Mental disorders such as depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder are among the diseases that cause loss of ability.
Rehabilitation services are important in order to support the adaptation of chronic mental patients to treatment outside the institution and to maintain their role in society. Self-sufficiency is one of the important issues to be addressed in chronic diseases that cause disability. Self-sufficiency refers to the individual's perception of the ability to successfully perform a certain action, the ability to control events, and the potential to accomplish a certain job. Individuals with high self-sufficiency set more difficult goals for themselves and make more efforts to achieve their goals. Since self-esteem is affected in mental disorders, self-sufficiency may be low.
High self-sufficiency leads to an increase in well-being. It is very important for psychological well-being for the individual to realize their potential and live a happy life. In recent years, attention has been paid to the well-being of individuals with mental disorders. Research has found that high well-being reduces disease recurrences. Some studies have also found that well-being is associated with having a depressive mood and an inability to cope with stress.
In psychological or physical diseases, educational intervention programs structured to teach people about their diseases and their emotional responses to the disease, to develop coping skills, to adapt to the disease, and to cooperate with treatment are defined as psychoeducation . The purpose of interventions is to teach individuals how to cope with their problems by creating knowledge and behavior changes, to help the patient to understand their own situation, to improve self-care activities, to prevent complications, to increase well-being and quality of life.
Studies in the literature conducted with different groups reveal that psychoeducation increases psychological resilience and supports coping with stress and feeling good. There are studies examining the effectiveness of psychoeducation from different aspects given to psychiatric patients. However, there is no study examining the effect of psychoeducation to evaluate the well-being and self-sufficiency of individuals who are in the rehabilitation phase and receive psychiatric treatment. The findings to be obtained as a result of the study will make a significant contribution to the psychiatric care and monitoring provided in day hospitals and rehabilitation centers and will create a database for new studies.
Purpose and hypotheses of the study This study was carried out to determine the effect of psychoeducation given in psychiatric day hospitals on the self-sufficiency and well-being of patients.
H1 Psychoeducation given in the psychiatric day hospital increases the self-sufficiency of the patients.
H2 Psychoeducation given in the psychiatric day hospital improves the well-being of the patients.
- Conditions
- Chronic Mental Disorder, Psychoeducation
- Being tested
- Psychoeducation
- Keywords
- chronic mental disorder, self-sufficiency, well-being, psychoeducation, psychiatric nurse, Turkey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
Psychoeducation sessions were conducted by two psychiatric nurses (İK, SS) who are experts in their fields and have psychoeducation and group leadership certificates. Each session was held once a week in 30-45 minutes sessions. The training was carried out interactively; approximately the first 5 minutes were spent on warm-up, the basic information of that day's session was given for 25 minutes, and the last 10 minutes were in the form of questions and answers. Two separate groups were formed according to the day hospital program of the patients, and the psychoeducation program was carried out in two separate groups to conduct psychoeducation effectively.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No intervention was applied to the control group in this process. * be receiving treatment in Clinic Day Hospital * Volunteering to participate in research |
| Psychoeducation | Experimental | * be receiving treatment in Clinic Day Hospital
* Volunteering to participate in research Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic Data Form
The form prepared by the researchers using the literature contains questions about the health status and the sociodemographic characteristics of individuals diagnosed with psychiatric diseases, such as age, gender, marital status, and educational status.
Measured: pre-intervention
General Self-Sufficiency Scale
The Turkish adaptation of the scale developed by Sherer et al. (1982) was carried out by Yıldırım \& İlhan (2010). The scale with a 5-point Likert structure consists of 17 items. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16 and 17 are scored in reverse. The total score that can be obtained varies between 17 and 85, and the increase in the score indicates increased self-sufficiency belief. The scale was applied by Yıldırım \& İlhan (2010) to 895 people aged 18 and over with at least five years of education. In the reliability study, the internal consistency coefficient was calculated as α = .80 for the whole scale and between .78 and .81 for each subscale.
Measured: pre-intervention
Well-being Scale
The Turkish adaptation study of the Well-Being Scale developed by Diener et al. (2009) was carried out by Fidan and Usta (2013). The scale has a 7-point Likert structure. The highest score that can be obtained from the scale is 56, and the lowest score is 8. There are no reverse-scored items on the scale. High scores from the scale indicate that the relevant individual has a high level of well-being. The reliability study of the scale was conducted by Fidan and Usta (2013) on a total of 385 high school 4th-grade students, 166 (43%) female and 219 (57%) male. The Cronbach alpha internal consistency coefficient of the Well-Being Scale was reported as .83.
Measured: pre-intervention
Secondary outcomes (2)
General Self-Sufficiency Scale:
The Turkish adaptation of the scale developed by Sherer et al. (1982) was carried out by Yıldırım \& İlhan (2010). The scale with a 5-point Likert structure consists of 17 items. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16 and 17 are scored in reverse. The total score that can be obtained varies between 17 and 85, and the increase in the score indicates increased self-sufficiency belief. The scale was applied by Yıldırım \& İlhan (2010) to 895 people aged 18 and over with at least five years of education. In the reliability study, the internal consistency coefficient was calculated as α = .80 for the whole scale and between .78 and .81 for each subscale.
Measured: immediately after the interventio
Well-being Scale:
The Turkish adaptation study of the Well-Being Scale developed by Diener et al. (2009) was carried out by Fidan and Usta (2013). The scale has a 7-point Likert structure. The highest score that can be obtained from the scale is 56, and the lowest score is 8. There are no reverse-scored items on the scale. High scores from the scale indicate that the relevant individual has a high level of well-being. The reliability study of the scale was conducted by Fidan and Usta (2013) on a total of 385 high school 4th-grade students, 166 (43%) female and 219 (57%) male. The Cronbach alpha internal consistency coefficient of the Well-Being Scale was reported as .83.
Measured: immediately after the interventio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Feb 2018
- Primary completion15 Feb 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Mental DisorderStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a single-blind randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkay KESER, Akdeniz University
- Investigators
- İlkay Keser, Study director, Akdeniz Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074004
- Sponsor's protocol ID
- 0707
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: research can be viewed by all researchers
Publications
Kizilirmak Tatu M, Demir S. Effect of Group Psychoeducation on Treatment Adherence, Quality of Life and Well-Being of Patients Diagnosed with Schizophrenia. Issues Ment Health Nurs. 2021 Mar;42(3):256-266. doi: 10.1080/01612840.2020.1793244. Epub 2020 Aug 12.
PubMed 32783665
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation Given In Psychiatry Day Hospital on The Self-Sufficiency and Well-Being of The Patients
- ClinicalTrials.gov ID
- NCT05074004
- Acronym / sponsor ID
- 0707
- Conditions
- Chronic Mental Disorder, Psychoeducation
- Keywords
- chronic mental disorder, self-sufficiency, well-being, psychoeducation, psychiatric nurse, Turkey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 12 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.
Background: Psychoeducation is a process used in the realization of the principles of treatment and rehabilitation of mental illnesses and aims to help the patient and his/her family outside the hospital, to help the patient cope with the problems, experiencing, and to support them to live productive lives in society.
Aims: This study aims to determine the effect of psychoeducation, given in a psychiatry dayhospital, on patients' self-sufficiency and well-being.
Methods: The research is a single-blind randomized controlled experimental study. The sample of the study consisted of 28 schizophrenic patient(14experiment-14control), who agreed to participate in the study, followed in XXX University Psychiatry Day Hospital. In the study, an 8-week psychoeducation program was applied to the experimental group, and no intervention was made tothe control group. Socio-demographic data form, self-sufficiency scale, and well-being scale were used as data collection tools. The data obtained were analyzed using theSPSS-23 package program.
Results: After the eight-week psychoeducation program, the pretest and posttest scores of the evaluations obtained from the scales of both groups were compared. It was found that while there was no change in thescores of the control group, there was an increase in the well-being and self-efficacy scores of the experimental group. While the increase in well-being was statistically significant(p<0.05), the increase in self-sufficiency score wasnot statistically significant(p>0.05), but the numerical increase was considered tobe aclinically significant result.
Detailed description
Mental illnesses cause deterioration in various areas of functionality such as personal care, family and social relations, communication, professional life, and leisure activities. Mental diseases that cause disability are common in society. Mental disorders such as depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder are among the diseases that cause loss of ability.
Rehabilitation services are important in order to support the adaptation of chronic mental patients to treatment outside the institution and to maintain their role in society. Self-sufficiency is one of the important issues to be addressed in chronic diseases that cause disability. Self-sufficiency refers to the individual's perception of the ability to successfully perform a certain action, the ability to control events, and the potential to accomplish a certain job. Individuals with high self-sufficiency set more difficult goals for themselves and make more efforts to achieve their goals. Since self-esteem is affected in mental disorders, self-sufficiency may be low.
High self-sufficiency leads to an increase in well-being. It is very important for psychological well-being for the individual to realize their potential and live a happy life. In recent years, attention has been paid to the well-being of individuals with mental disorders. Research has found that high well-being reduces disease recurrences. Some studies have also found that well-being is associated with having a depressive mood and an inability to cope with stress.
In psychological or physical diseases, educational intervention programs structured to teach people about their diseases and their emotional responses to the disease, to develop coping skills, to adapt to the disease, and to cooperate with treatment are defined as psychoeducation . The purpose of interventions is to teach individuals how to cope with their problems by creating knowledge and behavior changes, to help the patient to understand their own situation, to improve self-care activities, to prevent complications, to increase well-being and quality of life.
Studies in the literature conducted with different groups reveal that psychoeducation increases psychological resilience and supports coping with stress and feeling good. There are studies examining the effectiveness of psychoeducation from different aspects given to psychiatric patients. However, there is no study examining the effect of psychoeducation to evaluate the well-being and self-sufficiency of individuals who are in the rehabilitation phase and receive psychiatric treatment. The findings to be obtained as a result of the study will make a significant contribution to the psychiatric care and monitoring provided in day hospitals and rehabilitation centers and will create a database for new studies.
Purpose and hypotheses of the study This study was carried out to determine the effect of psychoeducation given in psychiatric day hospitals on the self-sufficiency and well-being of patients.
H1 Psychoeducation given in the psychiatric day hospital increases the self-sufficiency of the patients.
H2 Psychoeducation given in the psychiatric day hospital improves the well-being of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is a single-blind randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No intervention was applied to the control group in this process. * be receiving treatment in Clinic Day Hospital * Volunteering to participate in research |
| Psychoeducation | Experimental | Other: Psychoeducation* be receiving treatment in Clinic Day Hospital * Volunteering to participate in research |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who were followed up in the psychiatry day hospital,
- accepted to participate in the study,
- signed the informed consent form, and were able to read
Key exclusion criteria (3 listed)
- individuals indicating their desire to leave the study,
- the development of an attack requiring hospitalization,
- not attending education for more than two sessions.
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 |
|---|---|---|
| PsychoeducationPsychoeducation sessions were conducted by two psychiatric nurses (İK, SS) who are experts in their fields and have psychoeducation and group leadership certificates. Each session was held once a week in 30-45 minutes sessions. The training was carried out interactively; approximately the first 5 minutes were spent on warm-up, the basic information of that day's session was given for 25 minutes, and the last 10 minutes were in the form of questions and answers. Two separate groups were formed according to the day hospital program of the patients, and the psychoeducation program was carried out in two separate groups to conduct psychoeducation effectively. | Other | Psychoeducation |
Primary outcome
Socio-demographic Data Form
Time frame: pre-intervention
The form prepared by the researchers using the literature contains questions about the health status and the sociodemographic characteristics of individuals diagnosed with psychiatric diseases, such as age, gender, marital status, and educational status.
General Self-Sufficiency Scale
Time frame: pre-intervention
The Turkish adaptation of the scale developed by Sherer et al. (1982) was carried out by Yıldırım \& İlhan (2010). The scale with a 5-point Likert structure consists of 17 items. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16 and 17 are scored in reverse. The total score that can be obtained varies between 17 and 85, and the increase in the score indicates increased self-sufficiency belief. The scale was applied by Yıldırım \& İlhan (2010) to 895 people aged 18 and over with at least five years of education. In the reliability study, the internal consistency coefficient was calculated as α = .80 for the whole scale and between .78 and .81 for each subscale.
Well-being Scale
Time frame: pre-intervention
The Turkish adaptation study of the Well-Being Scale developed by Diener et al. (2009) was carried out by Fidan and Usta (2013). The scale has a 7-point Likert structure. The highest score that can be obtained from the scale is 56, and the lowest score is 8. There are no reverse-scored items on the scale. High scores from the scale indicate that the relevant individual has a high level of well-being. The reliability study of the scale was conducted by Fidan and Usta (2013) on a total of 385 high school 4th-grade students, 166 (43%) female and 219 (57%) male. The Cronbach alpha internal consistency coefficient of the Well-Being Scale was reported as .83.
2 secondary outcomes
General Self-Sufficiency Scale:
Time frame: immediately after the interventio
Well-being Scale:
Time frame: immediately after the interventio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 32783665Kizilirmak Tatu M, Demir S. Effect of Group Psychoeducation on Treatment Adherence, Quality of Life and Well-Being of Patients Diagnosed with Schizophrenia. Issues Ment Health Nurs. 2021 Mar;42(3):256-266. doi: 10.1080/01612840.2020.1793244. Epub 2020 Aug 12.
- Individual participant dataSharing planned: Yes. research can be viewed by all researchers
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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.
İlkay Keser study director
Akdeniz Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Chronic Mental Disorder and Psychoeducation, run by Akdeniz University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Socio-demographic Data Form (time frame: pre-intervention). 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 NCT05074004, which also lists 1 linked publication.
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 12 Oct 2021.