Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-12-25
2025-09-13
Brief Summary
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This randomized controlled study includes 40 patients assigned to either an experimental group or a control group. The experimental group receives a structured mindfulness-based psychoeducation program, while the control group receives treatment as usual without any additional intervention. Assessments are conducted before and after the intervention using a Personal Information Form, a Mindfulness Scale, and the Morisky Medication Adherence Scale.
Detailed Description
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Mindfulness-based interventions have been increasingly applied in mental health settings to support awareness of internal experiences, emotional regulation, and stress management. Mindfulness practices may contribute to treatment engagement by enhancing individuals' awareness of symptoms, daily routines, and coping responses. Psychoeducation is a core component of psychiatric nursing care and focuses on improving knowledge about illness, treatment processes, and coping strategies. Integrating mindfulness practices into a psychoeducation framework may offer a structured approach to supporting treatment engagement in individuals with schizophrenia.
Study Purpose
The primary purpose of this randomized controlled trial is to evaluate the effects of a structured mindfulness-based psychoeducation program on:
Mindfulness levels Treatment adherence among individuals diagnosed with schizophrenia. Study Design
This study uses a randomized controlled experimental design with pre-test and post-test measurements. Participants are randomly assigned to one of two groups:
Experimental group: Receives a structured mindfulness-based psychoeducation program delivered in weekly sessions.
Control group: Receives treatment as usual without additional intervention during the study period.
The intervention is designed to be applicable within routine psychiatric care settings and includes structured content focusing on mindfulness awareness, psychoeducation related to illness and treatment, and skill development.
Participants A total of 40 individuals diagnosed with schizophrenia are included in the study, with 20 participants in the experimental group and 20 in the control group. Participants are recruited from psychiatric outpatient clinics. Inclusion criteria include a clinical diagnosis of schizophrenia, clinical stability as determined by the treating psychiatrist, and sufficient cognitive capacity to participate in the intervention. Exclusion criteria include active psychotic symptoms, acute hospitalization, severe neurological disorders, or inability to provide informed consent.
Intervention Description
The mindfulness-based psychoeducation program consists of structured sessions delivered over a defined period. Each session includes:
Introduction to mindfulness concepts Guided mindfulness practices (e.g., breathing awareness, body scan, grounding exercises) Psychoeducation related to illness understanding, symptom management, and treatment processes Group discussion and reflection activities Homework assignments to support daily mindfulness practice The program is structured to support awareness of internal experiences, recognition of symptoms, and engagement with treatment routines.
Outcome Measures
Data are collected using the following instruments:
Mindfulness Scale: To assess levels of mindful awareness Morisky Medication Adherence Scale: To assess treatment adherence Personal Information Form: To collect demographic and clinical characteristics Measurements are obtained at baseline (pre-test) and after completion of the intervention (post-test).
Data Analysis Quantitative data analyses include descriptive statistics and comparisons of pre-test and post-test scores within and between groups using appropriate statistical methods.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mindfulness-Based Psychoeducation
Participants will receive an 8-session mindfulness-based psychoeducation program.
Mindfulness-Based Psychoeducation Program
A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.
Control: Routine Care
Participants in this arm will receive Routine Care provided by the psychiatric outpatient clinic. Routine Care includes standard follow-up, medication management, and usual clinical monitoring. No additional psychoeducation or mindfulness-based intervention will be provided during the study period.
Routine Care
Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.
Interventions
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Mindfulness-Based Psychoeducation Program
A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.
Routine Care
Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.
Eligibility Criteria
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Inclusion Criteria
* Age between 18-65 years
* Being clinically stable for at least the past 3 months
* Able to communicate, read, and understand Turkish
* Receiving outpatient psychiatric follow-up
* Willingness to participate and providing informed consent
Exclusion Criteria
* Comorbid intellectual disability, neurological disorder, or severe cognitive impairment
* Substance or alcohol dependence within the last 6 months
* Participation in any mindfulness-based or psychoeducational program within the last year
* Severe visual or hearing impairment preventing participation
* Any condition judged by the clinician to contraindicate participation in group sessions
18 Years
65 Years
ALL
No
Sponsors
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Ömer USLU
OTHER
Responsible Party
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Ömer USLU
Dr. Ömer Uslu, PhD - Principal Investigator
Principal Investigators
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Ömer Uslu, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Söke Fehime Faik Kocagöz Hospital
Locations
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Söke Fehime Faik Kocagöz State Hospital
Aydin, Söke, Turkey (Türkiye)
Countries
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Other Identifiers
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OMER-RCT-2025-SCH
Identifier Type: -
Identifier Source: org_study_id