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Depressive SymptomsNCT06926049

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

A study testing The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions in people with Depressive Symptoms and Hope, run by Gazi University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 1 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University

    Ankara, Province, 06930

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions
Keywords
difficulties of emotion regulation, depressive semptoms, hope, Psychiatric nursing
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Effect of The Mindfulness-Based Psycho-Educational Program Focused on EmotionsOther

    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.

Study groups in NCT06926049
Study groupRoleWhat they receive
Experimental: The Effect of The Mindfulness-Based Psycho-Educational Program Focused on EmotionsExperimentalThe 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.
Receives: Other: The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions
no interventionNo interventionWaiting 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Beck Depression Inventory (BDI)

    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.

    Measured: 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)

  2. Schizophrenia Hope Scale (SHS)

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
In the study, 48 schizophrenia patients were taken as sampling, 24 of which were experimental and 24 were control.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926049
Sponsor's protocol ID
Figen ŞENGÜN İNAN
Status last verified
Apr 2025
First submitted
7 Apr 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25105273

  • 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.

    PubMed 31302506

  • 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.

    PubMed 31661593

  • 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.

    PubMed 15994566

  • 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

  • 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.

    PubMed 30585413

Questions about this trial

What is this clinical trial studying?

A study testing The Effect of The Mindfulness-Based Psycho-Educational Program Focused on Emotions in people with Depressive Symptoms and Hope, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926049, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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Clinical Trial NCT06926049 | AzTrials