SchizophreniaNCT07310615
Mindfulness Psychoeducation for Schizophrenia
A study testing Mindfulness-Based Psychoeducation Program and Routine Care in people with Schizophrenia, run by Ömer USLU at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of a mindfulness-based psychoeducation program on mindfulness levels and treatment adherence among individuals diagnosed with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Mindfulness-Based Psychoeducation Program and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 13 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Söke Fehime Faik Kocagöz State Hospital
Aydin, Söke, 09200
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Mindfulness-Based Psychoeducation Program, Routine Care
- Keywords
- Schizophrenia, Mindfulness, Psychoeducation, Randomized Controlled Trial
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Psychoeducation ProgramBehavioural
A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.
Routine CareOther
Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Psychoeducation | Experimental | Participants will receive an 8-session mindfulness-based psychoeducation program. Receives: Behavioral: Mindfulness-Based Psychoeducation Program |
| Control: Routine Care | Active comparator | 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. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness level (Mindful Attention Awareness Scale)
Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS). Score range: 15-90. Higher scores indicate greater mindfulness.
Measured: Baseline and 8 weeks after intervention
Secondary outcomes (2)
Mindfulness level at 8 weeks (Mindful Attention Awareness Scale)
Description:
Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS). Score range: 15-90. Higher scores indicate greater mindfulness.
Measured: 8 weeks
Self-compassion level at 8 weeks (Self-Compassion Scale)
Self-compassion was assessed using the Self-Compassion Scale (SCS). Score range: 26-130. Higher scores indicate greater self-compassion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start25 Dec 2024
- Primary completion13 Jul 2025
- Study completion13 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömer USLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ömer USLU, Aydin Adnan Menderes University
- Investigators
- Ömer Uslu, PhD, RN, Principal investigator, Söke Fehime Faik Kocagöz Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310615
- Sponsor's protocol ID
- OMER-RCT-2025-SCH
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to ethical and institutional restrictions. The dataset includes sensitive health information from patients diagnosed with schizophrenia, and the informed consent process did not include permission for public data sharing. Therefore, in accordance with privacy regulations and ethical committee requirements, IPD will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Psychoeducation Improves Mindfulness and Medication Adherence in Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07310615
- Acronym / sponsor ID
- OMER-RCT-2025-SCH
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mindfulness, Psychoeducation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ömer USLUUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 13 Sep 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Psychoeducation | Experimental | Behavioral: Mindfulness-Based Psychoeducation ProgramParticipants will receive an 8-session mindfulness-based psychoeducation program. |
| Control: Routine Care | Active comparator | Other: Routine CareParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Psychoeducation ProgramA structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies. | Behavioural | Mindfulness-Based Psychoeducation |
| Routine CareStandard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided. | Other | Control: Routine Care |
Primary outcome
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.
2 secondary outcomes
Mindfulness level at 8 weeks (Mindful Attention Awareness Scale)
Time frame: 8 weeks
Self-compassion level at 8 weeks (Self-Compassion Scale)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to ethical and institutional restrictions. The dataset includes sensitive health information from patients diagnosed with schizophrenia, and the informed consent process did not include permission for public data sharing. Therefore, in accordance with privacy regulations and ethical committee requirements, IPD will not be made available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer Uslu, PhD, RN principal investigator
Söke Fehime Faik Kocagöz Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Psychoeducation Program and Routine Care in people with Schizophrenia, run by Ömer USLU at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness level (Mindful Attention Awareness Scale) (time frame: Baseline and 8 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.