ClinicalTrials.Veeva

Menu

Mindfulness Psychoeducation for Schizophrenia

Ö

Ömer USLU

Status

Completed

Conditions

Schizophrenia

Treatments

Behavioral: Mindfulness-Based Psychoeducation Program
Other: Routine Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07310615
OMER-RCT-2025-SCH

Details and patient eligibility

About

This study aims to examine the effects of a mindfulness-based psychoeducation program on mindfulness levels and treatment adherence among individuals diagnosed with schizophrenia. Schizophrenia is a chronic psychiatric disorder that affects thinking, emotions, and behavior, and difficulties in adhering to prescribed treatments are commonly observed. Poor treatment adherence is associated with relapse, increased hospitalization, and reduced overall functioning.

This randomized controlled study includes 40 patients assigned to either an experimental group or a control group. The experimental group receives a structured mindfulness-based psychoeducation program, while the control group receives treatment as usual without any additional intervention. Assessments are conducted before and after the intervention using a Personal Information Form, a Mindfulness Scale, and the Morisky Medication Adherence Scale.

Full description

Schizophrenia is a severe and chronic psychiatric disorder characterized by disturbances in thought processes, perceptions, emotions, and behaviors. Despite advances in pharmacological and psychosocial treatments, maintaining long-term treatment adherence remains a major challenge in the management of schizophrenia. Non-adherence to treatment is associated with adverse clinical outcomes, including relapse, rehospitalization, impaired functioning, and increased healthcare utilization.

Mindfulness-based interventions have been increasingly applied in mental health settings to support awareness of internal experiences, emotional regulation, and stress management. Mindfulness practices may contribute to treatment engagement by enhancing individuals' awareness of symptoms, daily routines, and coping responses. Psychoeducation is a core component of psychiatric nursing care and focuses on improving knowledge about illness, treatment processes, and coping strategies. Integrating mindfulness practices into a psychoeducation framework may offer a structured approach to supporting treatment engagement in individuals with schizophrenia.

Study Purpose

The primary purpose of this randomized controlled trial is to evaluate the effects of a structured mindfulness-based psychoeducation program on:

Mindfulness levels Treatment adherence among individuals diagnosed with schizophrenia. Study Design

This study uses a randomized controlled experimental design with pre-test and post-test measurements. Participants are randomly assigned to one of two groups:

Experimental group: Receives a structured mindfulness-based psychoeducation program delivered in weekly sessions.

Control group: Receives treatment as usual without additional intervention during the study period.

The intervention is designed to be applicable within routine psychiatric care settings and includes structured content focusing on mindfulness awareness, psychoeducation related to illness and treatment, and skill development.

Participants A total of 40 individuals diagnosed with schizophrenia are included in the study, with 20 participants in the experimental group and 20 in the control group. Participants are recruited from psychiatric outpatient clinics. Inclusion criteria include a clinical diagnosis of schizophrenia, clinical stability as determined by the treating psychiatrist, and sufficient cognitive capacity to participate in the intervention. Exclusion criteria include active psychotic symptoms, acute hospitalization, severe neurological disorders, or inability to provide informed consent.

Intervention Description

The mindfulness-based psychoeducation program consists of structured sessions delivered over a defined period. Each session includes:

Introduction to mindfulness concepts Guided mindfulness practices (e.g., breathing awareness, body scan, grounding exercises) Psychoeducation related to illness understanding, symptom management, and treatment processes Group discussion and reflection activities Homework assignments to support daily mindfulness practice The program is structured to support awareness of internal experiences, recognition of symptoms, and engagement with treatment routines.

Outcome Measures

Data are collected using the following instruments:

Mindfulness Scale: To assess levels of mindful awareness Morisky Medication Adherence Scale: To assess treatment adherence Personal Information Form: To collect demographic and clinical characteristics Measurements are obtained at baseline (pre-test) and after completion of the intervention (post-test).

Data Analysis Quantitative data analyses include descriptive statistics and comparisons of pre-test and post-test scores within and between groups using appropriate statistical methods.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of schizophrenia according to DSM-5 criteria
  • Age between 18-65 years
  • Being clinically stable for at least the past 3 months
  • Able to communicate, read, and understand Turkish
  • Receiving outpatient psychiatric follow-up
  • Willingness to participate and providing informed consent

Exclusion criteria

  • Presence of acute psychotic symptoms requiring immediate hospitalization
  • Comorbid intellectual disability, neurological disorder, or severe cognitive impairment
  • Substance or alcohol dependence within the last 6 months
  • Participation in any mindfulness-based or psychoeducational program within the last year
  • Severe visual or hearing impairment preventing participation
  • Any condition judged by the clinician to contraindicate participation in group sessions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Mindfulness-Based Psychoeducation
Experimental group
Description:
Participants will receive an 8-session mindfulness-based psychoeducation program.
Treatment:
Behavioral: Mindfulness-Based Psychoeducation Program
Control: Routine Care
Active Comparator group
Description:
Participants in this arm will receive Routine Care provided by the psychiatric outpatient clinic. Routine Care includes standard follow-up, medication management, and usual clinical monitoring. No additional psychoeducation or mindfulness-based intervention will be provided during the study period.
Treatment:
Other: Routine Care

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems