NCT07310615

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 9, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

SchizophreniaMindfulnessPsychoeducationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Mindfulness level (Mindful Attention Awareness Scale)

    Mindfulness was assessed using the Mindful Attention Awareness Scale (MAAS). Score range: 15-90. Higher scores indicate greater mindfulness.

    Baseline and 8 weeks after intervention

Secondary Outcomes (2)

  • Mindfulness level at 8 weeks (Mindful Attention Awareness Scale)

    8 weeks

  • Self-compassion level at 8 weeks (Self-Compassion Scale)

    8 weeks

Study Arms (2)

Mindfulness-Based Psychoeducation

EXPERIMENTAL

Participants will receive an 8-session mindfulness-based psychoeducation program.

Behavioral: Mindfulness-Based Psychoeducation Program

Control: Routine Care

ACTIVE COMPARATOR

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.

Other: Routine Care

Interventions

Standard outpatient psychiatric care delivered by the clinic. No additional psychoeducation or mindfulness intervention is provided.

Control: Routine Care

A structured 8-session mindfulness-based psychoeducation program including mindfulness exercises, psychoeducation, breathing techniques and adherence-support strategies.

Mindfulness-Based Psychoeducation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Söke Fehime Faik Kocagöz State Hospital

Aydin, Söke, 09200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ömer Uslu, PhD, RN

    Söke Fehime Faik Kocagöz Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the experimental group (mindfulness-based psychoeducation) or the control group with no intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Ömer Uslu, PhD - Principal Investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 30, 2025

Study Start

December 25, 2024

Primary Completion

July 13, 2025

Study Completion

September 13, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) from this study will not be shared due to ethical and institutional restrictions. The dataset includes sensitive health information from patients diagnosed with schizophrenia, and the informed consent process did not include permission for public data sharing. Therefore, in accordance with privacy regulations and ethical committee requirements, IPD will not be made available to other researchers

Locations