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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926049
Enrollment
48
Registered
2025-04-13
Start date
2025-03-01
Completion date
2025-12-01
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, Difficulties of Emotion Regulation, Hope

Keywords

difficulties of emotion regulation, depressive semptoms, hope, Psychiatric nursing

Brief summary

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.

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.

Interventions

OTHERThe 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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the study, it is not possible to blind the researcher implementing the intervention and the participants. To prevent bias in the study, the pretest will be applied before randomization. It is planned to blind the statistical and report writing process in the study. The assignment of schizophrenia patients to the intervention and control groups will be made by a statistician independent of the study. The researcher and schizophrenia patients will not know which group they are in until the application begins. After applying the follow-up tests, the researcher will code the data as A and B groups and transfer it to SPSS. With this method, it is planned that the statistician will do the analysis and reporting without knowing which group is the intervention and which group is the control group. It is planned to explain the codes of the groups after the analysis and reporting of the data. In this way, detection bias, statistical bias, and reporting bias will be prevented

Intervention model description

In the study, 48 schizophrenia patients were taken as sampling, 24 of which were experimental and 24 were control.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)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

MeasureTime frameDescription
Beck Depression Inventory (BDI)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.
Schizophrenia Hope Scale (SHS)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026