Clinical trial NCT06926049: The Mindfulness-Based Psycho-Educational Program Focused on Emotion Regulation Strategies
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Hope
Difficulties of Emotion Regulation
Keywords: difficulties of emotion regulation
depressive semptoms
hope
Psychiatric nursing
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the study, 48 schizophrenia patients were taken as sampling, 24 of which were experimental and 24 were control.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale-Brief Form (DERS-16)
timeFrame: 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 outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 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)
measure: Schizophrenia Hope Scale (SHS)
timeFrame: 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 outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Province
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.