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NCT Number: NCT06926049

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Difficulties of Emotion Regulation Hope

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Province, 06930, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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