SchizophreniaMED-ADHERENCT07374588
Impact of Medication Education on Adherence and Side Effects
A study testing Medication Education Program and Routine Psychiatric Inpatient Care in people with Schizophrenia and Schizoaffective Disorder, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Severe mental disorders such as schizophrenia, bipolar disorder, and psychotic depression often require long-term or lifelong medication treatment. However, many psychiatric patients have difficulty adhering to their prescribed medication regimens due to factors such as lack of information, fear of side effects, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features
- What is being tested?
- Medication Education Program and Routine Psychiatric Inpatient Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 15 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Hospitalized in a psychiatric inpatient clinic
- Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, or major depressive disorder with psychotic features
- Receiving psychotropic medication treatment
- Clinically stable and able to participate in educational sessions
- Able to communicate verbally and understand the content of the education
- Provided written informed consent
Who cannot join
- Presence of severe cognitive impairment or intellectual disability
- Acute medical or neurological conditions that may interfere with participation
- Severe agitation or acute psychotic symptoms preventing participation
- Hearing or communication impairments that limit participation in educational sessions
- Participation in another psychosocial intervention study during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet Univesity Hospital
Sivas, Sivas, 58400
About this study
Official title: The Effect of Medication Education on Treatment Adherence and Side Effects in Psychiatric Inpatients: An Intervention Study
Severe mental disorders such as schizophrenia, bipolar disorder, and psychotic depression often require long-term or lifelong medication treatment. However, many psychiatric patients have difficulty adhering to their prescribed medication regimens due to factors such as lack of information, fear of side effects, and negative experiences with psychotropic medications. Poor treatment adherence is associated with symptom relapse, prolonged hospitalization, increased rehospitalization rates, reduced quality of life, and higher health care costs.
Medication education is a key psychosocial intervention aimed at improving patients' understanding of their illness, treatment process, and potential medication side effects. Providing structured medication education may enhance treatment adherence and help patients recognize and manage side effects more effectively.
This intervention study aims to evaluate the effect of a structured medication education program on treatment adherence and medication-related side effects among psychotic inpatients hospitalized in a psychiatric clinic, including patients diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, and major depressive disorder with psychotic features. The findings of this study are expected to contribute to the development of effective psychosocial interventions to improve medication adherence and treatment outcomes in psychiatric inpatient settings.
Read the detailed description
Mental disorders with psychotic features, such as schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, and psychotic depression, are chronic conditions that often require long-term or lifelong pharmacological treatment. Despite the effectiveness of psychotropic medications in symptom control and relapse prevention, treatment non-adherence remains a major challenge in psychiatric care. Medication non-adherence in psychiatric patients is associated with increased relapse rates, prolonged hospitalization, involuntary admissions, poorer prognosis, increased suicide risk, and higher health care costs. One of the most frequently reported reasons for non-adherence is the experience of, or fear of experiencing, medication-related side effects.
Medication education is a structured psychosocial intervention designed to improve patients' knowledge about their illness, prescribed medications, expected benefits, possible side effects, and strategies for managing adverse effects. Increasing patients' understanding of their treatment may enhance insight, reduce anxiety related to medication use, and improve treatment adherence.
This intervention study aims to evaluate the effect of a structured medication education program on treatment adherence and medication-related side effects among psychotic inpatients hospitalized in a psychiatric clinic. The study population consists of patients diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, and major depressive disorder with psychotic features.
Participants will receive routine psychiatric inpatient care. In addition, the intervention group will receive a structured medication education program delivered by trained mental health professionals. The medication education program includes information about the nature of the psychiatric illness, the purpose and benefits of prescribed medications, correct medication use, potential side effects, and strategies for recognizing and managing common adverse effects. Educational sessions are designed to be interactive and tailored to patients' cognitive and clinical status.
Treatment adherence and medication-related side effects will be assessed using validated measurement tools at predefined time points. The outcomes of the intervention group will be compared with those of the control group receiving standard care alone.
The results of this study are expected to provide evidence on the effectiveness of medication education as a psychosocial intervention for improving treatment adherence and reducing the negative impact of medication side effects in psychiatric inpatient settings. The findings may contribute to the development of standardized educational interventions aimed at improving long-term treatment outcomes and quality of life in patients with severe mental disorders.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depressive Disorder With Psychotic Features
- Being tested
- Medication Education Program, Routine Psychiatric Inpatient Care
- Keywords
- Medication Education, Psychiatric Inpatients, Psychoeducation, Treatment Adherence, Medication Side Effects
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Treatment Adherence and Compliance, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Education ProgramBehavioural
Structured medication education provided in addition to routine psychiatric inpatient care.
Routine Psychiatric Inpatient CareBehavioural
Standard psychiatric inpatient care including pharmacological treatment and routine nursing care provided according to hospital protocols. No additional medication education is provided.
| Study group | Role | What they receive |
|---|---|---|
| Medication Education + Routine Care | Experimental | Participants in this arm will receive routine psychiatric inpatient care in addition to a structured medication education program. The medication education aims to improve medication adherence and enhance coping with medication-related side effects. The education will be delivered by the researchers in two sessions, each lasting 45 minutes, using teaching, discussion, and role-playing methods. Receives: Behavioral: Medication Education Program |
| Routine Care | Active comparator | Participants in this arm will receive routine psychiatric inpatient care only, including standard pharmacological treatment and nursing care provided according to hospital protocols. No additional medication education will be provided. Receives: Behavioral: Routine Psychiatric Inpatient Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Treatment adherence will be assessed by evaluating patients' adherence to prescribed psychotropic medications, including regular medication use and compliance with the treatment regimen, using a validated medication adherence assessment tool.
Measured: Baseline and at the end of the intervention period during hospitalization (up to 5 days)
Secondary outcomes (1)
Medication-Related Side Effects
Medication-related side effects will be assessed by evaluating the presence, frequency, and severity of psychotropic medication side effects using a validated side effect assessment scale.
Measured: Baseline and at the end of the intervention period during hospitalization (up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start30 Jan 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either an intervention group receiving structured medication education in addition to routine care or a control group receiving routine psychiatric inpatient care alone.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özge kısaoğlu, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374588
- Sponsor's protocol ID
- 2025-07/33
- Acronym
- MED-ADHERE
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medication Education on Treatment Adherence and Side Effects in Psychiatric Inpatients: An Intervention Study
- ClinicalTrials.gov ID
- NCT07374588
- Acronym / sponsor ID
- MED-ADHERE / 2025-07/33
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depressive Disorder With Psychotic Features
- Keywords
- Medication Education, Psychiatric Inpatients, Psychoeducation, Treatment Adherence, Medication Side Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 29 Jan 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.
Severe mental disorders such as schizophrenia, bipolar disorder, and psychotic depression often require long-term or lifelong medication treatment. However, many psychiatric patients have difficulty adhering to their prescribed medication regimens due to factors such as lack of information, fear of side effects, and negative experiences with psychotropic medications. Poor treatment adherence is associated with symptom relapse, prolonged hospitalization, increased rehospitalization rates, reduced quality of life, and higher health care costs.
Medication education is a key psychosocial intervention aimed at improving patients' understanding of their illness, treatment process, and potential medication side effects. Providing structured medication education may enhance treatment adherence and help patients recognize and manage side effects more effectively.
This intervention study aims to evaluate the effect of a structured medication education program on treatment adherence and medication-related side effects among psychotic inpatients hospitalized in a psychiatric clinic, including patients diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, and major depressive disorder with psychotic features. The findings of this study are expected to contribute to the development of effective psychosocial interventions to improve medication adherence and treatment outcomes in psychiatric inpatient settings.
Detailed description
Mental disorders with psychotic features, such as schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, and psychotic depression, are chronic conditions that often require long-term or lifelong pharmacological treatment. Despite the effectiveness of psychotropic medications in symptom control and relapse prevention, treatment non-adherence remains a major challenge in psychiatric care. Medication non-adherence in psychiatric patients is associated with increased relapse rates, prolonged hospitalization, involuntary admissions, poorer prognosis, increased suicide risk, and higher health care costs. One of the most frequently reported reasons for non-adherence is the experience of, or fear of experiencing, medication-related side effects.
Medication education is a structured psychosocial intervention designed to improve patients' knowledge about their illness, prescribed medications, expected benefits, possible side effects, and strategies for managing adverse effects. Increasing patients' understanding of their treatment may enhance insight, reduce anxiety related to medication use, and improve treatment adherence.
This intervention study aims to evaluate the effect of a structured medication education program on treatment adherence and medication-related side effects among psychotic inpatients hospitalized in a psychiatric clinic. The study population consists of patients diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, and major depressive disorder with psychotic features.
Participants will receive routine psychiatric inpatient care. In addition, the intervention group will receive a structured medication education program delivered by trained mental health professionals. The medication education program includes information about the nature of the psychiatric illness, the purpose and benefits of prescribed medications, correct medication use, potential side effects, and strategies for recognizing and managing common adverse effects. Educational sessions are designed to be interactive and tailored to patients' cognitive and clinical status.
Treatment adherence and medication-related side effects will be assessed using validated measurement tools at predefined time points. The outcomes of the intervention group will be compared with those of the control group receiving standard care alone.
The results of this study are expected to provide evidence on the effectiveness of medication education as a psychosocial intervention for improving treatment adherence and reducing the negative impact of medication side effects in psychiatric inpatient settings. The findings may contribute to the development of standardized educational interventions aimed at improving long-term treatment outcomes and quality of life in patients with severe mental disorders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either an intervention group receiving structured medication education in addition to routine care or a control group receiving routine psychiatric inpatient care alone.
| Arm | Type | Receives |
|---|---|---|
| Medication Education + Routine Care | Experimental | Behavioral: Medication Education ProgramParticipants in this arm will receive routine psychiatric inpatient care in addition to a structured medication education program. The medication education aims to improve medication adherence and enhance coping with medication-related side effects. The education will be delivered by the researchers in two sessions, each lasting 45 minutes, using teaching, discussion, and role-playing methods. |
| Routine Care | Active comparator | Behavioral: Routine Psychiatric Inpatient CareParticipants in this arm will receive routine psychiatric inpatient care only, including standard pharmacological treatment and nursing care provided according to hospital protocols. No additional medication education will be provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-65 years
- Hospitalized in a psychiatric inpatient clinic
- Diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder with psychotic features, or major depressive disorder with psychotic features
- Receiving psychotropic medication treatment
- Clinically stable and able to participate in educational sessions
Key exclusion criteria (5 listed)
- Presence of severe cognitive impairment or intellectual disability
- Acute medical or neurological conditions that may interfere with participation
- Severe agitation or acute psychotic symptoms preventing participation
- Hearing or communication impairments that limit participation in educational sessions
- Participation in another psychosocial intervention study during the study period
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 |
|---|---|---|
| Medication Education ProgramStructured medication education provided in addition to routine psychiatric inpatient care. | Behavioural | Medication Education + Routine Care |
| Routine Psychiatric Inpatient CareStandard psychiatric inpatient care including pharmacological treatment and routine nursing care provided according to hospital protocols. No additional medication education is provided. | Behavioural | Routine Care |
Primary outcome
Treatment Adherence
Time frame: Baseline and at the end of the intervention period during hospitalization (up to 5 days)
Treatment adherence will be assessed by evaluating patients' adherence to prescribed psychotropic medications, including regular medication use and compliance with the treatment regimen, using a validated medication adherence assessment tool.
1 secondary outcome
Medication-Related Side Effects
Time frame: Baseline and at the end of the intervention period during hospitalization (up to 5 days)
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
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 Medication Education Program and Routine Psychiatric Inpatient Care in people with Schizophrenia and Schizoaffective Disorder, run by Cumhuriyet University 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 7 inclusion and 5 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 24 Aug 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 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?
Treatment Adherence (time frame: Baseline and at the end of the intervention period during hospitalization (up to 5 days)). 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 24 Aug 2026.