NCT07327944

Brief 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. 30 patients were in the experimental group and 30 were in the control group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

27 days

First QC Date

December 26, 2025

Last Update Submit

December 26, 2025

Conditions

Keywords

Schizophreniarelapse managementfunctional recoveryrandomized controlled studypsychiatric nursing

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Change from before implementation, after the practice is completed, 4 weeks after the practice is finished.

Study Arms (2)

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.

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients diagnosed with schizophrenia in the experimental and control groups will be masked.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 8, 2026

Study Start

February 1, 2026

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share