Quality of LifeNCT04280835
Psychoeducation in Patients Who Diagnosed With Schizophrenia
A study testing Group Psychoeducation that Focused on Social Skill Development in people with Quality of Life and Well-Being, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Quality of Life, Well-Being, Compliance, Treatment
- What is being tested?
- Group Psychoeducation that Focused on Social Skill Development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Jun 2019
- 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 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteering
- Being 18 and over being literate
- Having been diagnosed with schizophrenia for at least three months
- Taking oral antipsychotics
- Being in remission.
Who cannot join
- Being in an acute period of exacerbation
- Actively using alcohol or psychoactive substances
- Having mental retardation or dementia
- Having another psychiatric illness that makes it impossible to cooperate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Group Psychoeducation That Focused on Social Skills Development Applied to Patients Who Diagnosed With Schizophrenia on Treatment Compliance, Quality of Life and Well-being
People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. It is known that psychoeducation practices aimed at developing social skills in schizophrenia give patients new skills and these skills continue for many years. This study aimed to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.
Read the detailed description
The aim is to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.
The study was conducted with 42 schizophrenia patients (n=21 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication Adherence Rating Scale (MARS)", "Quality of Life Scale for Schizophrenia (QLSS)" and "Flourishing Scale" (FS). The measurements were taken 3 times: pre test, post-test and 3-months post-test.
- Conditions
- Quality of Life, Well-Being, Compliance, Treatment
- Being tested
- Group Psychoeducation that Focused on Social Skill Development
- Keywords
- schizophrenia, psychoeducation, compliance to treatment, quality of life, well-being
- Medical subject headings
- Patient Compliance, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Psychoeducation that Focused on Social Skill DevelopmentBehavioural
Psychoeducation Program consists of; Preparatory Session, Recognition of Schizophrenia, Evaluating the Treatment of Schizophrenia, Stress and Coping with Stress, Improving Communication Skills, Improving Problem-solving Skills, Improving Interpersonal relationships and social activities and Evaluating Session.The sessions were held in the form of PowerPoint presentations. In the psychoeducation program, lecture, question-answer, homework, sharing experiences, group discussion, repetition, video presentation, summarization, reinforcer, and role-playing techniques were used. The day before each session, patients were phoned and reminded of the time of the session. At the end of each session, the content of the subject is given as hard copy and cookies, tea and coffee were served.
| Study group | Role | What they receive |
|---|---|---|
| Group Psychoeducation that Focused on Social Skill Development | Experimental | The Psychoeducation program that focused on social skill development, consists of 8 sessions, one day a week, each lasting an average of 60 Minutes. Psychoeducation was conducted in three groups and each of them consisted of eight patients. Receives: Behavioral: Group Psychoeducation that Focused on Social Skill Development |
| Control Group | No intervention | No intervention was performed on the patients in the control group, and routine follow-up (arranging treatment by the doctor, answering the patient's and family's questions about treatment) continued in the polyclinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale for Schizophrenia (QLSS)
It evaluates the quality of life of schizophrenic patients receiving maintenance treatment. QLSS provides information about ongoing symptoms and functionality. It is a 7-degree Likert type scale applied in a semi-structured interview format. It consists of a total of four sub-dimensions and 21 questions in the form of interpersonal relationships, professional role, psychic findings and daily item use-activities. The total score of all subscales gives the total score (0-126) of quality of life.
Measured: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
Medication Adherence Rating Scale (MARS)
The scale assesses the patient's compliance behaviors and attitude to treatment. The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high).
Measured: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
Flourishing Scale (FS)
It is a self-assessment scale measures an individual's level of well-being. It consists of eight items and each item is scored 1-7 points. The total score range from 8-56 points. The more the score from the scale increases the more the well-being increases.
Measured: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jan 2019
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The research was using quasi-experimental research methods. The experimental group was composed of patients with schizophrenia registered at Community Mental Health Center and the control group was composed of outpatients diagnosed with schizophrenia who applied to Psychiatric Polyclinic.The patients met the inclusion criteria of the study and volunteered to participate in the study.The study was completed with 42 patients (n=21for the intervention group; n=21 patients for the control group).Psychoeducation program were applied to intervention group. No intervention was performed on the patients in the control group.To the experimental and control group, at screening (pre-test), eight weeks after screening (post-intervention/post-test), three months after the post tests (follow-up) was applied.The mesurements were taken simultaneously in the intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Kızılırmak Tatu, Gazi University
- Investigators
- Merve Kızılırmak Tatu, PhD, Principal investigator, Gazi University Health Science Faculty, Ankara, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280835
- Sponsor's protocol ID
- MKTatu
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group Psychoeducation That Focused on Social Skills Development Applied to Patients Who Diagnosed With Schizophrenia on Treatment Compliance, Quality of Life and Well-being
- ClinicalTrials.gov ID
- NCT04280835
- Acronym / sponsor ID
- MKTatu
- Conditions
- Quality of Life, Well-Being, Compliance, Treatment
- Keywords
- schizophrenia, psychoeducation, compliance to treatment, quality of life, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Feb 2020 (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.
People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. It is known that psychoeducation practices aimed at developing social skills in schizophrenia give patients new skills and these skills continue for many years. This study aimed to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.
Detailed description
The aim is to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.
The study was conducted with 42 schizophrenia patients (n=21 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication Adherence Rating Scale (MARS)", "Quality of Life Scale for Schizophrenia (QLSS)" and "Flourishing Scale" (FS). The measurements were taken 3 times: pre test, post-test and 3-months post-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research was using quasi-experimental research methods. The experimental group was composed of patients with schizophrenia registered at Community Mental Health Center and the control group was composed of outpatients diagnosed with schizophrenia who applied to Psychiatric Polyclinic.The patients met the inclusion criteria of the study and volunteered to participate in the study.The study was completed with 42 patients (n=21for the intervention group; n=21 patients for the control group).Psychoeducation program were applied to intervention group. No intervention was performed on the patients in the control group.To the experimental and control group, at screening (pre-test), eight weeks after screening (post-intervention/post-test), three months after the post tests (follow-up) was applied.The mesurements were taken simultaneously in the intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Group Psychoeducation that Focused on Social Skill Development | Experimental | Behavioral: Group Psychoeducation that Focused on Social Skill DevelopmentThe Psychoeducation program that focused on social skill development, consists of 8 sessions, one day a week, each lasting an average of 60 Minutes. Psychoeducation was conducted in three groups and each of them consisted of eight patients. |
| Control Group | No intervention | –No intervention was performed on the patients in the control group, and routine follow-up (arranging treatment by the doctor, answering the patient's and family's questions about treatment) continued in the polyclinic. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering
- Being 18 and over being literate
- Having been diagnosed with schizophrenia for at least three months
- Taking oral antipsychotics
- Being in remission.
Key exclusion criteria (4 listed)
- Being in an acute period of exacerbation
- Actively using alcohol or psychoactive substances
- Having mental retardation or dementia
- Having another psychiatric illness that makes it impossible to cooperate.
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 |
|---|---|---|
| Group Psychoeducation that Focused on Social Skill DevelopmentPsychoeducation Program consists of; Preparatory Session, Recognition of Schizophrenia, Evaluating the Treatment of Schizophrenia, Stress and Coping with Stress, Improving Communication Skills, Improving Problem-solving Skills, Improving Interpersonal relationships and social activities and Evaluating Session.The sessions were held in the form of PowerPoint presentations. In the psychoeducation program, lecture, question-answer, homework, sharing experiences, group discussion, repetition, video presentation, summarization, reinforcer, and role-playing techniques were used. The day before each session, patients were phoned and reminded of the time of the session. At the end of each session, the content of the subject is given as hard copy and cookies, tea and coffee were served. | Behavioural | Group Psychoeducation that Focused on Social Skill Development |
Primary outcome
Quality of Life Scale for Schizophrenia (QLSS)
Time frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
It evaluates the quality of life of schizophrenic patients receiving maintenance treatment. QLSS provides information about ongoing symptoms and functionality. It is a 7-degree Likert type scale applied in a semi-structured interview format. It consists of a total of four sub-dimensions and 21 questions in the form of interpersonal relationships, professional role, psychic findings and daily item use-activities. The total score of all subscales gives the total score (0-126) of quality of life.
Medication Adherence Rating Scale (MARS)
Time frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
The scale assesses the patient's compliance behaviors and attitude to treatment. The scale consists of 10 questions to answer in the form of Yes/No (between 1-7 were poor in compliance with treatment and those with scores between 8-10 were high).
Flourishing Scale (FS)
Time frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)
It is a self-assessment scale measures an individual's level of well-being. It consists of eight items and each item is scored 1-7 points. The total score range from 8-56 points. The more the score from the scale increases the more the well-being increases.
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 21 Feb 2020.
- Individual participant dataSharing planned: No. Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.
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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.
Merve Kızılırmak Tatu, PhD principal investigator
Gazi University Health Science Faculty, Ankara, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychoeducation that Focused on Social Skill Development in people with Quality of Life and Well-Being, run by Gazi 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 5 inclusion and 4 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 21 Feb 2020. 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?
Quality of Life Scale for Schizophrenia (QLSS) (time frame: Change from baseline to 8 weeks (also assessed at 20 weeks post-baseline)). 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?
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 21 Feb 2020.