Impact of Medication Education on Adherence and Side Effects (MED-ADHERE)

Cumhuriyet University

Status: Not yet enrolling

Conditions: Schizophrenia; Bipolar Disorder With Psychotic Features; Schizoaffective Disorder; Major Depressive Disorder With Psychotic Features

Treatments: Behavioral: Medication Education Program; Behavioral: Routine Psychiatric Inpatient Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07374588

2025-07/33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Medication Education + Routine Care

Experimental group

Description:

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.

Treatment:

Behavioral: Medication Education Program

Routine Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Routine Psychiatric Inpatient Care