Impact of Medication Education on Adherence and Side Effects

NCT07374588 | Not Yet Recruiting

• 1 other identifier: 2025-07/33
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at the end of the intervention period during hospitalization (up to 5 days)

Secondary Outcomes (1)

• Medication-Related Side Effects

  Baseline and at the end of the intervention period during hospitalization (up to 5 days)

Study Arms (2)

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.

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.

Behavioral: Routine Psychiatric Inpatient Care

Interventions

Medication Education Program BEHAVIORAL

Structured medication education provided in addition to routine psychiatric inpatient care.

Medication Education + Routine Care

Routine Psychiatric Inpatient Care BEHAVIORAL

Standard psychiatric inpatient care including pharmacological treatment and routine nursing care provided according to hospital protocols. No additional medication education is provided.

Routine Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Treatment Adherence and Compliance; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatric Nursing

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 29, 2026
• Study Start: January 2, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share