Relapse ManagementNCT07327944
Relapse Management Group Psychoeducation Program
A study testing Relapse Management Group Psychoeducation Program in people with Relapse Management, run by Ankara Etlik City Hospital.
Trial summary
This study was planned to be conducted between February and March 2026, with a total of 60 patients diagnosed with schizophrenia who met the inclusion criteria and were followed at the community mental health center in the Psychiatry Building of Ankara Etlik City Hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapse Management
- What is being tested?
- Relapse Management Group Psychoeducation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Mar 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Able to speak and understand Turkish
- Written consent obtained
- Being a patient diagnosed with schizophrenia who is being monitored at the relevant institution during the study period
- Being in remission Exclusion Criteria
- Those who have previously received or are currently receiving psychoeducation on relapse management
Show all 9Show fewer
- Those who do not attend community mental health center follow-ups regularly
- Those with mental retardation that may prevent participation in psychoeducation
- Those in the relapse phase of the disease
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Relapse Management Group Psychoeducation Program Applied to Schizophrenia Patients on Relapse Management and Functional Recovery
This study was planned to be conducted between February and March 2026, with a total of 60 patients diagnosed with schizophrenia who met the inclusion criteria and were followed at the community mental health center in the Psychiatry Building of Ankara Etlik City Hospital. 30 patients were in the experimental group and 30 were in the control group.
Read the detailed description
Schizophrenia patients in the experimental and control group will complete the Data Collection Form before (pretest) and immediately after (posttest) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026. The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, the relationship between relapse and functioning in schizophrenia, how to manage relapse in schizophrenia, and potential interventions. The pretest will be administered before the program, and the posttest will be administered four weeks after the sessions. Schizophrenia patients in the control group will not receive the relapse management group psychoeducation program and will continue their daily care at the center. Schizophrenia patients in the control group will complete a Data Collection Form at the same time (pretest, posttest) as the experimental group.
- Conditions
- Relapse Management
- Being tested
- Relapse Management Group Psychoeducation Program
- Keywords
- Schizophrenia, relapse management, functional recovery, randomized controlled study, psychiatric nursing
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapse Management Group Psychoeducation ProgramOther
Schizophrenia patients in the experimental group will complete the Data Collection Form before (pre-test) and immediately after (post-test) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026. The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, relapse in schizophrenia, the relationship between relapse and functioning, how to manage relapse in schizophrenia, and potential interventions. The pre-test will be administered before the program, the post-test will be administered after the sessions, and the follow up-test will be administered four weeks after the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Schizophrenia patients in the experimental group will complete the Data Collection Form before (pretest) and immediately after (posttest) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026 The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, the relationship between relapse and functioning in schizophrenia, how to manage relapse in schizophrenia, and potential interventions. The pre-test will be administered before the program, the post-test will be administered after the sessions, and the follow up-test will be administered four weeks after the sessions. Receives: Other: Relapse Management Group Psychoeducation Program |
| Control group | No intervention | There will be no training or intervention. Schizophrenia patients in the control group will not receive the relapse management group psychoeducation program and will continue their daily care at the center. Schizophrenia patients in the control group will complete a Data Collection Form at the same time (pretest, posttest, follow up-test) as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Warning Signs of Relapse Questionnaire
This scale was developed by Abu Sabra in 2023 to assess the ability of patients and their primary caregivers to self-manage symptoms of relapse. The scale is scored by asking participants (patients and their primary caregivers). The survey consists of a total of 20 questions: 10 for patients and 10 for their relatives. The patient version (10-question section) of the scale for which the Turkish validity and reliability study will be used. The 5-point Likert-type scale is scored as follows: "I can't do it at all" ("1"), "I can do it very little" ("2"), "I can do it a little" ("3"), "I can do it moderately" ("4"), and "I can do it extremely" ("5"). The highest score for each group is 50, and the lowest is 10. The survey has no cut-off point. Higher scores represent higher levels of self-management ability. The Cronbach's Alpha coefficient of the total items of the relapse early warning signs questionnaire is 0.96 (the Cronbach's Alpha coefficient of the patient items is 0.95 and the Cro
Measured: Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
Functional Recovery Scale for Patients with Schizophrenia
Functional Recovery Scale for Patients with Schizophrenia was first developed by Llorca et al (2009). The validity and reliability of the scale in Turkey was conducted by Emiroğlu in 2009. The scale is a 5-point Likert-type scale consisting of 19 items. Each item has five levels of evaluation. Level 1 (absent) indicates the lowest level of improvement, while level 5 (excellently present) corresponds to the ideal level of functioning. Level 2 (partially present), Level 3 (sufficiently present), and Level 4 (almost completely present) are included. High scores indicate high functioning, while low scores indicate low functioning. When between two levels, the lower level is selected. The maximum score is 95, and the minimum score is 19. The scale consists of four subscales: social functioning, health and treatment, daily living skills, and occupational functioning. The social functioning subscale requires a minimum of 7 points and a maximum of 35 points; the health and treatment subscale
Measured: Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse ManagementStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Principal investigator, Bahar Akkaya, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327944
- Sponsor's protocol ID
- Etlik city hospital
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Relapse Management Group Psychoeducation Program Applied to Schizophrenia Patients on Relapse Management and Functional Recovery
- ClinicalTrials.gov ID
- NCT07327944
- Acronym / sponsor ID
- Etlik city hospital
- Conditions
- Relapse Management
- Keywords
- Schizophrenia, relapse management, functional recovery, randomized controlled study, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Collaborators
- Çankırı Karatekin University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Jan 2026 (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 was planned to be conducted between February and March 2026, with a total of 60 patients diagnosed with schizophrenia who met the inclusion criteria and were followed at the community mental health center in the Psychiatry Building of Ankara Etlik City Hospital. 30 patients were in the experimental group and 30 were in the control group.
Detailed description
Schizophrenia patients in the experimental and control group will complete the Data Collection Form before (pretest) and immediately after (posttest) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026. The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, the relationship between relapse and functioning in schizophrenia, how to manage relapse in schizophrenia, and potential interventions. The pretest will be administered before the program, and the posttest will be administered four weeks after the sessions. Schizophrenia patients in the control group will not receive the relapse management group psychoeducation program and will continue their daily care at the center. Schizophrenia patients in the control group will complete a Data Collection Form at the same time (pretest, posttest) as the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Relapse Management Group Psychoeducation ProgramSchizophrenia patients in the experimental group will complete the Data Collection Form before (pretest) and immediately after (posttest) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026 The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, the relationship between relapse and functioning in schizophrenia, how to manage relapse in schizophrenia, and potential interventions. The pre-test will be administered before the program, the post-test will be administered after the sessions, and the follow up-test will be administered four weeks after the sessions. |
| Control group | No intervention | –There will be no training or intervention. Schizophrenia patients in the control group will not receive the relapse management group psychoeducation program and will continue their daily care at the center. Schizophrenia patients in the control group will complete a Data Collection Form at the same time (pretest, posttest, follow up-test) as the experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 and over
- Able to speak and understand Turkish
- Written consent obtained
- Being a patient diagnosed with schizophrenia who is being monitored at the relevant institution during the study period
- Being in remission Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Relapse Management Group Psychoeducation ProgramSchizophrenia patients in the experimental group will complete the Data Collection Form before (pre-test) and immediately after (post-test) the relapse management group psychoeducation program. The researchers will implement the relapse management group psychoeducation program with schizophrenia patients being followed at the community mental health center between February and March 2026. The program will include a total of four 60 minute group psychoeducation sessions. The program will cover the symptoms of schizophrenia, the definition of functioning in schizophrenia, relapse in schizophrenia, the relationship between relapse and functioning, how to manage relapse in schizophrenia, and potential interventions. The pre-test will be administered before the program, the post-test will be administered after the sessions, and the follow up-test will be administered four weeks after the sessions. | Other | Experimental group |
Primary outcome
Early Warning Signs of Relapse Questionnaire
Time frame: Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
This scale was developed by Abu Sabra in 2023 to assess the ability of patients and their primary caregivers to self-manage symptoms of relapse. The scale is scored by asking participants (patients and their primary caregivers). The survey consists of a total of 20 questions: 10 for patients and 10 for their relatives. The patient version (10-question section) of the scale for which the Turkish validity and reliability study will be used. The 5-point Likert-type scale is scored as follows: "I can't do it at all" ("1"), "I can do it very little" ("2"), "I can do it a little" ("3"), "I can do it moderately" ("4"), and "I can do it extremely" ("5"). The highest score for each group is 50, and the lowest is 10. The survey has no cut-off point. Higher scores represent higher levels of self-management ability. The Cronbach's Alpha coefficient of the total items of the relapse early warning signs questionnaire is 0.96 (the Cronbach's Alpha coefficient of the patient items is 0.95 and the Cro
Functional Recovery Scale for Patients with Schizophrenia
Time frame: Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
Functional Recovery Scale for Patients with Schizophrenia was first developed by Llorca et al (2009). The validity and reliability of the scale in Turkey was conducted by Emiroğlu in 2009. The scale is a 5-point Likert-type scale consisting of 19 items. Each item has five levels of evaluation. Level 1 (absent) indicates the lowest level of improvement, while level 5 (excellently present) corresponds to the ideal level of functioning. Level 2 (partially present), Level 3 (sufficiently present), and Level 4 (almost completely present) are included. High scores indicate high functioning, while low scores indicate low functioning. When between two levels, the lower level is selected. The maximum score is 95, and the minimum score is 19. The scale consists of four subscales: social functioning, health and treatment, daily living skills, and occupational functioning. The social functioning subscale requires a minimum of 7 points and a maximum of 35 points; the health and treatment subscale
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 8 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Relapse Management Group Psychoeducation Program in people with Relapse Management, run by Ankara Etlik City Hospital.
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 9 inclusion and 0 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 8 Jan 2026. 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?
Contact Bahar Akkaya (0312 797 0000, akkayabahar2130@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Warning Signs of Relapse Questionnaire (time frame: Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.). The study lists 2 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 8 Jan 2026.