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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Relapse Management Group Psychoeducation Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Çankırı Karatekin University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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