SchiphreniaMIPNI-SchizoNCT07917520
Mindfulness-Integrated Psychoeducation for Patients With Schizophrenia
A study testing Mindfulness-Integrated Psychoeducational Nursing Intervention in people with Schiphrenia, run by Menoufia University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of a mindfulness-integrated psychoeducational nursing intervention in enhancing insight, improving medication adherence, and reducing aggressive behaviors among patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schiphrenia
- What is being tested?
- Mindfulness-Integrated Psychoeducational Nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 15 Mar 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults aged 20-60 years, able to communicate effectively, literate, and also willing to take part voluntarily
Who cannot join
- patients with neurocognitive impairment, or those with an acute psychotic worsening, recent cognitive behavioral therapy, electroconvulsive therapy happening in the last six months, or severe coexisting medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Insight, Improving Medication Adherence, and Reducing Aggressive Behaviors in Patients With Schizophrenia: Effectiveness of a Mindfulness-Integrated Psychoeducational Nursing Intervention
This study aims to evaluate the effectiveness of a mindfulness-integrated psychoeducational nursing intervention in enhancing insight, improving medication adherence, and reducing aggressive behaviors among patients with schizophrenia. The intervention combines mindfulness techniques with psychoeducational nursing sessions to help patients better understand their illness, recognize the importance of medication adherence, and develop strategies to manage emotions and aggressive behaviors. The study will assess changes in patients' insight, medication adherence, and aggressive behaviors before and after the intervention. The findings may help improve nursing care and support recovery and better clinical outcomes among patients with schizophrenia.
Read the detailed description
Schizophrenia is a chronic mental health disorder that can affect patients' insight into their illness, adherence to prescribed medication, and ability to regulate emotions and behaviors. Poor insight and medication nonadherence may contribute to symptom relapse, hospitalization, and difficulties in maintaining long-term stability. Aggressive behaviors may also create challenges for patients, families, and healthcare professionals. Therefore, nursing interventions that address these interrelated problems are important for improving patient outcomes.
Mindfulness-integrated psychoeducation is a nursing approach that combines education about schizophrenia, its symptoms, treatment, and medication adherence with mindfulness techniques. Mindfulness practices may help patients develop greater awareness of their thoughts, emotions, and behavioral responses. Psychoeducation can help patients understand their illness, recognize the importance of treatment, and participate more actively in their care.
This study aims to evaluate the effectiveness of a mindfulness-integrated psychoeducational nursing intervention in improving insight, enhancing medication adherence, and reducing aggressive behaviors among patients with schizophrenia.
The intervention will provide structured nursing education and mindfulness-based activities according to the study protocol. The study outcomes will be assessed using appropriate assessment instruments at the time points specified in the research protocol. Changes in patients' insight, medication adherence, and aggressive behaviors will be examined to determine the effectiveness of the intervention.
The findings may provide evidence to support the integration of mindfulness techniques and psychoeducational nursing interventions into psychiatric nursing practice and may contribute to improving treatment engagement and clinical outcomes among patients with schizophrenia.
- Conditions
- Schiphrenia
- Being tested
- Mindfulness-Integrated Psychoeducational Nursing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Integrated Psychoeducational Nursing InterventionBehavioural
The intervention consists of a structured mindfulness-integrated psychoeducational nursing program for patients with schizophrenia. It combines psychoeducation about schizophrenia, its symptoms, treatment options, and the importance of medication adherence with mindfulness techniques intended to improve awareness of thoughts and emotions, emotional regulation, and behavioral self-control. The program aims to enhance patients' insight into their illness, improve adherence to prescribed medication, and reduce aggressive behaviors. The intervention is delivered by psychiatric nursing professionals according to the study protocol, and its outcomes are evaluated using the assessment instruments specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Integrated Psychoeducational Nursing Intervention Group | Experimental | Participants in this group received a structured mindfulness-integrated psychoeducational nursing intervention designed to enhance insight into schizophrenia, improve medication adherence, and reduce aggressive behaviors. Receives: Behavioral: Mindfulness-Integrated Psychoeducational Nursing Intervention |
| Control Group | No intervention | Participants in this group received routine care without the structured mindfulness-integrated psycho educational nursing intervention . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insight and Medication Adherence from baseline to 12 weeks after the intervention, measured using the Birchwood Insight Scale (BIS) and Morisky Medication Adherence Scale (MMAS-8)
Insight and Medication Adherence will be assessed using the Birchwood Insight Scale (BIS) and Morisky Medication Adherence Scale (MMAS-8) . these scales are validated instruments used to assess clinical insight and adherence to prescribed psychiatric medications among patients with schizophrenia, respectively. Higher scores indicate better insight and medication adherence. Changes in scores from baseline to 12 weeks post-intervention will be analyzed.
Measured: Baseline and 12 weeks after the intervention
Secondary outcomes (1)
Change in Aggressive Behavior outcomes from baseline to 12 weeks after the intervention, measured using a validated the Buss-Perry Aggression Questionnaire
Aggressive behaviors will be measured using the Buss-Perry Aggression Questionnaire (BPAQ), a validated instrument assessing different dimensions of aggression, including physical aggression, verbal aggression, anger, and hostility. Higher scores indicate greater levels of aggression. Changes from baseline to 12 weeks post-intervention will be evaluated.
Measured: Baseline and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Sep 2025
- Primary completion3 Jan 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchiphreniaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 assigned to a single group and received a structured psychiatric nursing intervention. Outcomes were assessed before and after the intervention to evaluate its effectiveness.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917520
- Sponsor's protocol ID
- ERCNMA1000/6/8/155/25
- Acronym
- MIPNI-Schizo
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study data are confidential and were collected for research purposes only. Access to the data is restricted to the research team
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Insight, Improving Medication Adherence, and Reducing Aggressive Behaviors in Patients With Schizophrenia: Effectiveness of a Mindfulness-Integrated Psychoeducational Nursing Intervention
- ClinicalTrials.gov ID
- NCT07917520
- Acronym / sponsor ID
- MIPNI-Schizo / ERCNMA1000/6/8/155/25
- Conditions
- Schiphrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 3 Jan 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 4 Nov 2026 (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 evaluate the effectiveness of a mindfulness-integrated psychoeducational nursing intervention in enhancing insight, improving medication adherence, and reducing aggressive behaviors among patients with schizophrenia. The intervention combines mindfulness techniques with psychoeducational nursing sessions to help patients better understand their illness, recognize the importance of medication adherence, and develop strategies to manage emotions and aggressive behaviors. The study will assess changes in patients' insight, medication adherence, and aggressive behaviors before and after the intervention. The findings may help improve nursing care and support recovery and better clinical outcomes among patients with schizophrenia.
Detailed description
Schizophrenia is a chronic mental health disorder that can affect patients' insight into their illness, adherence to prescribed medication, and ability to regulate emotions and behaviors. Poor insight and medication nonadherence may contribute to symptom relapse, hospitalization, and difficulties in maintaining long-term stability. Aggressive behaviors may also create challenges for patients, families, and healthcare professionals. Therefore, nursing interventions that address these interrelated problems are important for improving patient outcomes.
Mindfulness-integrated psychoeducation is a nursing approach that combines education about schizophrenia, its symptoms, treatment, and medication adherence with mindfulness techniques. Mindfulness practices may help patients develop greater awareness of their thoughts, emotions, and behavioral responses. Psychoeducation can help patients understand their illness, recognize the importance of treatment, and participate more actively in their care.
This study aims to evaluate the effectiveness of a mindfulness-integrated psychoeducational nursing intervention in improving insight, enhancing medication adherence, and reducing aggressive behaviors among patients with schizophrenia.
The intervention will provide structured nursing education and mindfulness-based activities according to the study protocol. The study outcomes will be assessed using appropriate assessment instruments at the time points specified in the research protocol. Changes in patients' insight, medication adherence, and aggressive behaviors will be examined to determine the effectiveness of the intervention.
The findings may provide evidence to support the integration of mindfulness techniques and psychoeducational nursing interventions into psychiatric nursing practice and may contribute to improving treatment engagement and clinical outcomes among patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to a single group and received a structured psychiatric nursing intervention. Outcomes were assessed before and after the intervention to evaluate its effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Integrated Psychoeducational Nursing Intervention Group | Experimental | Behavioral: Mindfulness-Integrated Psychoeducational Nursing InterventionParticipants in this group received a structured mindfulness-integrated psychoeducational nursing intervention designed to enhance insight into schizophrenia, improve medication adherence, and reduce aggressive behaviors. |
| Control Group | No intervention | –Participants in this group received routine care without the structured mindfulness-integrated psycho educational nursing intervention . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults aged 20-60 years, able to communicate effectively, literate, and also willing to take part voluntarily
Key exclusion criteria (1 listed)
- patients with neurocognitive impairment, or those with an acute psychotic worsening, recent cognitive behavioral therapy, electroconvulsive therapy happening in the last six months, or severe coexisting medical illness
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-Integrated Psychoeducational Nursing InterventionThe intervention consists of a structured mindfulness-integrated psychoeducational nursing program for patients with schizophrenia. It combines psychoeducation about schizophrenia, its symptoms, treatment options, and the importance of medication adherence with mindfulness techniques intended to improve awareness of thoughts and emotions, emotional regulation, and behavioral self-control. The program aims to enhance patients' insight into their illness, improve adherence to prescribed medication, and reduce aggressive behaviors. The intervention is delivered by psychiatric nursing professionals according to the study protocol, and its outcomes are evaluated using the assessment instruments specified in the protocol. | Behavioural | Mindfulness-Integrated Psychoeducational Nursing Intervention Group |
Primary outcome
Changes in Insight and Medication Adherence from baseline to 12 weeks after the intervention, measured using the Birchwood Insight Scale (BIS) and Morisky Medication Adherence Scale (MMAS-8)
Time frame: Baseline and 12 weeks after the intervention
Insight and Medication Adherence will be assessed using the Birchwood Insight Scale (BIS) and Morisky Medication Adherence Scale (MMAS-8) . these scales are validated instruments used to assess clinical insight and adherence to prescribed psychiatric medications among patients with schizophrenia, respectively. Higher scores indicate better insight and medication adherence. Changes in scores from baseline to 12 weeks post-intervention will be analyzed.
1 secondary outcome
Change in Aggressive Behavior outcomes from baseline to 12 weeks after the intervention, measured using a validated the Buss-Perry Aggression Questionnaire
Time frame: Baseline and 12 weeks after the intervention
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study data are confidential and were collected for research purposes only. Access to the data is restricted to the research team
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.
The record lists no contact. Use the official record to reach the sponsor.
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-Integrated Psychoeducational Nursing Intervention in people with Schiphrenia, run by Menoufia University at 1 site in Egypt.
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 1 inclusion and 1 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 4 Nov 2026. 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 Egypt. 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?
Changes in Insight and Medication Adherence from baseline to 12 weeks after the intervention, measured using the Birchwood Insight Scale (BIS) and Morisky Medication Adherence Scale (MMAS-8) (time frame: Baseline and 12 weeks after the 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 4 Nov 2026.