- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327944
Relapse Management Group Psychoeducation Program
December 26, 2025 updated by: Bahar Akkaya, Ankara Etlik City Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bahar Akkaya
- Phone Number: 0312 797 0000
- Email: akkayabahar2130@icloud.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
|
|
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
|
Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
December 26, 2025
First Submitted That Met QC Criteria
December 26, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 26, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Etlik City Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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