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

NCT ID: NCT06926049

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Depressive Symptoms Hope Difficulties of Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Figen Şengün İnan

ASSOCIATE PROFESSOR DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University

Ankara, Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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O'Driscoll C, Laing J, Mason O. Cognitive emotion regulation strategies, alexithymia and dissociation in schizophrenia, a review and meta-analysis. Clin Psychol Rev. 2014 Aug;34(6):482-95. doi: 10.1016/j.cpr.2014.07.002. Epub 2014 Jul 24.

Reference Type BACKGROUND
PMID: 25105273 (View on PubMed)

Ludwig L, Werner D, Lincoln TM. The relevance of cognitive emotion regulation to psychotic symptoms - A systematic review and meta-analysis. Clin Psychol Rev. 2019 Aug;72:101746. doi: 10.1016/j.cpr.2019.101746. Epub 2019 Jun 14.

Reference Type BACKGROUND
PMID: 31302506 (View on PubMed)

Lawlor C, Hepworth C, Smallwood J, Carter B, Jolley S. Self-reported emotion regulation difficulties in people with psychosis compared with non-clinical controls: A systematic literature review. Clin Psychol Psychother. 2020 Mar;27(2):107-135. doi: 10.1002/cpp.2408. Epub 2020 Feb 12.

Reference Type BACKGROUND
PMID: 31661593 (View on PubMed)

Hawton K, Sutton L, Haw C, Sinclair J, Deeks JJ. Schizophrenia and suicide: systematic review of risk factors. Br J Psychiatry. 2005 Jul;187:9-20. doi: 10.1192/bjp.187.1.9.

Reference Type BACKGROUND
PMID: 15994566 (View on PubMed)

Gratz, K.L., Roemer, L. (2004). Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26, 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94

Reference Type BACKGROUND

Cho M, Jang SJ. Effect of an emotion management programme for patients with schizophrenia: A quasi-experimental design. Int J Ment Health Nurs. 2019 Apr;28(2):592-604. doi: 10.1111/inm.12565. Epub 2018 Dec 25.

Reference Type BACKGROUND
PMID: 30585413 (View on PubMed)

Other Identifiers

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Figen ŞENGÜN İNAN

Identifier Type: -

Identifier Source: org_study_id

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