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

January 24, 2026 updated by: özge kısaoğlu, Cumhuriyet University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medication Education + Routine Care
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
Structured medication education provided in addition to routine psychiatric inpatient care.
Active Comparator: Routine Care
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
Standard psychiatric inpatient care including pharmacological treatment and routine nursing care provided according to hospital protocols. No additional medication education is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at the end of the intervention period during hospitalization (up to 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication-Related Side Effects
Time Frame: Baseline and at the end of the intervention period during hospitalization (up to 5 days)
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.
Baseline and at the end of the intervention period during hospitalization (up to 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2026

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

June 2, 2026

Study Registration Dates

First Submitted

January 10, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-07/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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