- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310615
Mindfulness Psychoeducation for Schizophrenia
Mindfulness-Based Psychoeducation Improves Mindfulness and Medication Adherence in Schizophrenia: A Randomized Controlled Trial
This study aims to examine the effects of a mindfulness-based psychoeducation program on mindfulness levels and treatment adherence among individuals diagnosed with schizophrenia. Schizophrenia is a chronic psychiatric disorder that affects thinking, emotions, and behavior, and difficulties in adhering to prescribed treatments are commonly observed. Poor treatment adherence is associated with relapse, increased hospitalization, and reduced overall functioning.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Schizophrenia is a severe and chronic psychiatric disorder characterized by disturbances in thought processes, perceptions, emotions, and behaviors. Despite advances in pharmacological and psychosocial treatments, maintaining long-term treatment adherence remains a major challenge in the management of schizophrenia. Non-adherence to treatment is associated with adverse clinical outcomes, including relapse, rehospitalization, impaired functioning, and increased healthcare utilization.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Söke
-
Aydin, Söke, Turkey (Türkiye), 09200
- Söke Fehime Faik Kocagöz State Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of schizophrenia according to DSM-5 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:
- Presence of acute psychotic symptoms requiring immediate hospitalization
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Psychoeducation
Participants will receive an 8-session mindfulness-based psychoeducation program.
|
A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.
|
|
Active Comparator: 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.
|
Standard outpatient psychiatric care delivered by the clinic.
No additional psychoeducation or mindfulness intervention is provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness level (Mindful Attention Awareness Scale)
Time Frame: Baseline and 8 weeks after intervention
|
Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS).
Score range: 15-90.
Higher scores indicate greater mindfulness.
|
Baseline and 8 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness level at 8 weeks (Mindful Attention Awareness Scale)
Time Frame: 8 weeks
|
Description: Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS). Score range: 15-90. Higher scores indicate greater mindfulness. |
8 weeks
|
|
Self-compassion level at 8 weeks (Self-Compassion Scale)
Time Frame: 8 weeks
|
Self-compassion was assessed using the Self-Compassion Scale (SCS).
Score range: 26-130.
Higher scores indicate greater self-compassion.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ömer Uslu, PhD, RN, Söke Fehime Faik Kocagöz Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMER-RCT-2025-SCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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