The Mindfulness-Based Psycho-Educational Program Focused on Emotion Regulation Strategies

April 16, 2025 updated by: Figen Şengün İnan, Gazi University

The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions on Difficulties in Emotion Regulation, Depressive Symptoms and Hope Level in Schizophrenia Patients

In this study, the effects of a mindfulness-based emotion-focused psychoeducation program applied to individuals diagnosed with schizophrenia on emotion regulation difficulties, depressive symptoms, and hope levels will be examined. The research will be carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is a chronic illness that begins at a young age and leads to impairments in thought, perception, and affect. Patients experience a loss of functionality in occupational, social, and personal areas and face emotional challenges such as depression, anxiety, and hopelessness. Difficulties in emotion regulation are common among individuals with schizophrenia, making disease management more challenging.

Emotion regulation refers to the process of recognizing, accepting, and managing emotions using appropriate strategies. Literature indicates that difficulties in emotion regulation among individuals with schizophrenia are associated with depression and an increased risk of suicide. Mindfulness-based interventions have been found effective in enhancing emotion regulation skills and reducing depressive symptoms, rumination, and hallucinations.

This study aims to examine the effects of a mindfulness-based psychoeducation program for individuals diagnosed with schizophrenia on emotion regulation difficulties, depressive symptoms, and levels of hope. The findings are expected to contribute to nurse-led interventions that support the mental health and rehabilitation process of patients.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Province
      • Ankara, Province, Turkey, 06930
        • Gazi University

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:

  1. Being diagnosed with schizophrenia according to DSM-5 diagnostic criteria
  2. Being between 18-65 years old
  3. Not having any problems with communication
  4. Being literate
  5. Being willing to participate in the research
  6. Having schizophrenia for at least 2 years

Exclusion Criteria:

  1. Having a neurological disease
  2. Having a neurocognitive disease
  3. Having comorbid depression according to DSM-5 diagnostic criteria
  4. Being a substance abuser
  5. Having participated in and currently receiving a structured psychotherapeutic intervention program within the last year

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions
The mindfullness based psychoeducation program focusing on emotions to be carried out with the experimental group is planned as 5 sessions. The sessions are planned to be held in 2 groups of 12 people each. The duration of a session is planned as 45-60 minutes. Group psychoeducation with the experimental group will be carried out face to face every week. The appropriate day for the sessions will be decided with the members of each group. The same group session will be held on the same day and time every week.
Other: The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions
The mindfulness based psychoeducation program focusing on emotions that aims to reduce the difficulties in regulating emotions and depressive symptoms in schizophrenia patients and to increase the level of hope.
No Intervention: no intervention
Waiting list group after the follow-up tests were completed, it was planned to apply the 5-session group psychoeducation applied to the intervention group in the same way to the control group, upon their request.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)
Time Frame: Change from baseline in the mean emotion regulation difficulties scores at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)
The scale is a 16-item self-report measure, developed by Bjureberg et al. (2016). DERS-16 is used to evaluate various aspects of emotion regulation difficulties. It comprises five subscales, namely Clarity (e.g., "I have difficulty making sense of my feelings"), Goals (e.g., "When I'm upset, I have difficulty getting work done"), Impulse (e.g., "When I'm upset, I feel out of control"), Strategies (e.g., "When I'm upset, I start to feel very bad about myself"), and Non-acceptance (e.g., "When I'm upset, I feel like I am weak"). The items in DERS-16 are rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Higher scores indicate greater emotion dysregulation. There are no reverse-coded items in the scale.
Change from baseline in the mean emotion regulation difficulties scores at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: Change from baseline in the mean depression scores at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)
It was developed by Beck and his colleagues to control the presence and severity of depression. The scale consists of 21 items. The items consist of four items that define a specific behavioral pattern and are scored from zero to three. The score that can be obtained from the scale varies between 0-63. The aim of the scale is to express the symptoms of depression in numbers rather than to diagnose any depression in the participants. It was determined that the presence and severity of depression is higher as the total score increases. Minimal depression will be determined between 0-9 points, Mild depression 10-16 points, Moderate depression 17-29 points and Severe depression 30-63 points. It measures the physical, emotional and cognitive symptoms seen in depression. The higher the total score, the more severe the depression.
Change from baseline in the mean depression scores at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)
Schizophrenia Hope Scale (SHS)
Time Frame: Change from baseline in the mean hope score at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)
It is a scale developed by Choe (2014) to determine the hope levels of individuals diagnosed with schizophrenia. The scale, which consists of a total of 9 questions, is a three-point Likert type (0=disagree, 1=agree 2=strongly agree). The total score obtained from the scale is between 0 and 18. The scale does not have a cut-off point, and high scores obtained from the scale are interpreted as individuals diagnosed with schizophrenia having high levels of hope.
Change from baseline in the mean hope score at the 1st-month follow-up and the 3rd-month follow-up. (baseline, 1st month follow-up, 3rd month follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic Characteristics Data Collection Form
Time Frame: (baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)
The sociodemographic characteristics data collection form prepared by the researchers consists of a total of 8 questions including age, gender, education status, marital status, who they live with, employment status, income status and disease duration.
(baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pretest-posttest follow-up experimental design)

Collaborators and Investigators

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

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Figen ŞENGÜN İNAN

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

product manufactured in and exported from the U.S.

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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