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

NCT06926049 | Active Not Recruiting

• 1 other identifier: Figen ŞENGÜN İNAN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Hope; Difficulties of Emotion Regulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

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

EXPERIMENTAL

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

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.

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Province, 06930, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 25105273 BACKGROUND

• 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.

  PMID: 31302506 BACKGROUND

• 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.

  PMID: 31661593 BACKGROUND

• 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.

  PMID: 15994566 BACKGROUND

• 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

  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.

  PMID: 30585413 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR DOCTOR

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

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)