Schizophrenia PatientsSchizophreniaNCT06872424
The Effect of Psychosocial Skills Focused Group Psychoeducation in Schizophrenia Patients
A study testing psychosocial skills-oriented group psychoeducation in people with Schizophrenia Patients and Psychoeducation, run by Gazi University.
Trial summary
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Schizophrenia Patients, Psychoeducation, Functional Status
- What is being tested?
- psychosocial skills-oriented group psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having a diagnosis of schizophrenia according to DSM-5 diagnostic criteria
- To have continuity in the Community Mental Health Center
- Being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor,
- To be mentally capable of understanding the questions posed
- To have the cognitive competence to understand the training provided
- Not having any visual or auditory disability
- Graduating from at least primary school
Who cannot join
- Refusing to participate in the study
- Being under 18 years of age
- Being illiterate in Turkish
- Having Mental Retardation
About this study
Official title: The Effect of Psychosocial Skills Focused Group Psychoeducation on Functional Improvement, Treatment Compliance and Mental Well-Being in Schizophrenia Patients: a Randomised Controlled Study
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.
Read the detailed description
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Thus, the effect of the psychoeducation program on the determined parameters will be evaluated. After the completion of the research, short-term counseling services will be provided to the control group in line with ethical principles. SPSS 25 package program will be used for data analysis.
- Conditions
- Schizophrenia Patients, Psychoeducation, Functional Status, Treatment Outcome, Mental Development
- Being tested
- psychosocial skills-oriented group psychoeducation
- Keywords
- Schizophrenia, Psychoeducation, Functional recovery, Treatment adherence, Mental well-being
- Medical subject headings
- Schizophrenia, Treatment Adherence and Compliance, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial skills-oriented group psychoeducationBehavioural
A 5-session Psychosocial Skills Focused Group Psychoeducation will be implemented, each session lasting approximately 60-90 minutes. In order to make the training more active and effective, the experimental group will be divided into small groups and divided into 3 groups and each group will be given 5 sessions of Psychosocial Skills Focused Group Psychoeducation once a week.
| Study group | Role | What they receive |
|---|---|---|
| Effect of psychoeducation on schizophrenia patients | Experimental | Experimental and control group Receives: Behavioral: psychosocial skills-oriented group psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Recovery Scale in Schizophrenia
Functional Recovery Scale: The scale is 5-point Likert-type and consists of 19 items. The maximum score that can be obtained from the scale is 95 and the minimum score is 19. Patients who score below 58 points are considered to have a low level of Functional Recovery, patients who score between 59-65 points are considered to have a moderate level of Functional Recovery, and patients who score 66 points and above are considered to have a high level.
Measured: 1 day
Morisky Treatment Adherence Scale
Morisky Treatment Adherence Scale: The scale consists of 4 closed-ended questions with two options (yes/no). Medication adherence is assessed as high if "no" is answered to all questions (4 points), moderate if "yes" is answered to one or two questions (2-3 points), and low if "yes" is answered to three or four questions (0-1 pn).
Measured: 1 day
Warwick-Edinburgh Mental Well-Being Scale
Warwick-Edinburgh Mental Well-Being Scale: The scale consists of 14 items and each question is scored between 1-5. The total score range is 14-70. A higher score indicates a higher level of mental well-being.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Pre-test post-test control group study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Güzide Emirza, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872424
- Sponsor's protocol ID
- EGUEM
- Acronym
- Schizophrenia
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychosocial Skills Focused Group Psychoeducation on Functional Improvement, Treatment Compliance and Mental Well-Being in Schizophrenia Patients: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06872424
- Acronym / sponsor ID
- Schizophrenia / EGUEM
- Conditions
- Schizophrenia Patients, Psychoeducation, Functional Status, Treatment Outcome, Mental Development
- Keywords
- Schizophrenia, Psychoeducation, Functional recovery, Treatment adherence, Mental well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 12 Mar 2025 (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.
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.
Detailed description
The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Thus, the effect of the psychoeducation program on the determined parameters will be evaluated. After the completion of the research, short-term counseling services will be provided to the control group in line with ethical principles. SPSS 25 package program will be used for data analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-test post-test control group study
| Arm | Type | Receives |
|---|---|---|
| Effect of psychoeducation on schizophrenia patients | Experimental | Behavioral: psychosocial skills-oriented group psychoeducationExperimental and control group |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Having a diagnosis of schizophrenia according to DSM-5 diagnostic criteria
- To have continuity in the Community Mental Health Center
- Being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor,
- To be mentally capable of understanding the questions posed
- To have the cognitive competence to understand the training provided
Key exclusion criteria (4 listed)
- Refusing to participate in the study
- Being under 18 years of age
- Being illiterate in Turkish
- Having Mental Retardation
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 |
|---|---|---|
| psychosocial skills-oriented group psychoeducationA 5-session Psychosocial Skills Focused Group Psychoeducation will be implemented, each session lasting approximately 60-90 minutes. In order to make the training more active and effective, the experimental group will be divided into small groups and divided into 3 groups and each group will be given 5 sessions of Psychosocial Skills Focused Group Psychoeducation once a week. | Behavioural | Effect of psychoeducation on schizophrenia patients |
Primary outcome
Functional Recovery Scale in Schizophrenia
Time frame: 1 day
Functional Recovery Scale: The scale is 5-point Likert-type and consists of 19 items. The maximum score that can be obtained from the scale is 95 and the minimum score is 19. Patients who score below 58 points are considered to have a low level of Functional Recovery, patients who score between 59-65 points are considered to have a moderate level of Functional Recovery, and patients who score 66 points and above are considered to have a high level.
Morisky Treatment Adherence Scale
Time frame: 1 day
Morisky Treatment Adherence Scale: The scale consists of 4 closed-ended questions with two options (yes/no). Medication adherence is assessed as high if "no" is answered to all questions (4 points), moderate if "yes" is answered to one or two questions (2-3 points), and low if "yes" is answered to three or four questions (0-1 pn).
Warwick-Edinburgh Mental Well-Being Scale
Time frame: 1 day
Warwick-Edinburgh Mental Well-Being Scale: The scale consists of 14 items and each question is scored between 1-5. The total score range is 14-70. A higher score indicates a higher level of mental well-being.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial skills-oriented group psychoeducation in people with Schizophrenia Patients and Psychoeducation, run by Gazi University.
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 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Functional Recovery Scale in Schizophrenia (time frame: 1 day). 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 12 Mar 2025.