NCT07130227

Brief Summary

This study aimed to determine the effects of mindfulness-based stress reduction training on anger management and functional recovery in patients with schizophrenia. The study will be conducted at a CMHC in Ağrı province between May and August 2021. At the CMHC, community-based mental health services are provided to patients with severe mental disorders (schizophrenia, bipolar disorder) who are in remission as assessed by a psychiatrist. The study is planned to be conducted with patients who meet the study criteria, without using a sample selection method. Patients over the age of 18 registered with CMHC and followed with a diagnosis of schizophrenia were contacted by phone and invited to CMHC. The study was conducted with patients who met the inclusion criteria and agreed to participate (psychoeducational group, mindfulness group, control group). Data will be collected using the Descriptive Characteristics Form, the State and Trait Anger Inventory, and the SILO. The mindfulness group received 16 sessions of MBRS training, and the psychoeducational group received an 8-session psychoeducational program. The control group received no intervention. The study sample size was calculated using the GPower computer program. Power analysis at α=0.05 yielded an effect size of 150, 153 (d=0.8), and the study had 90% power. Therefore, it was calculated that a minimum of 68 patients should be included in the sample.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

mindfulnessSchizophreniaPsychoeducationNursing

Outcome Measures

Primary Outcomes (1)

  • Personal Information Form

    This form consists of a total of eight questions (age, gender, marital status, education level, duration of illness, income, family history of mental illness, and employment status) developed by the researcher based on literature and includes the sociodemographic characteristics of the patients

    up to 1 day

Secondary Outcomes (1)

  • The State-Trait Anger Scale (STAS)

    up to 1 day

Other Outcomes (1)

  • Functional Recovery Scale in Schizophrenia (FRS)

    up to 1 day

Study Arms (24)

Session 1: Preparatory Session

EXPERIMENTAL

\*Meeting the patients \*Introducing the content of mindfulness-based stress reduction training \*Emphasizing the importance of regular and timely attendance at training \*Determining training dates \*Sharing individuals' experiences and expectations

Other: Session 1: Preparatory Session

Session 2: Mindfulness

EXPERIMENTAL

\*What is mindfulness? \*Being aware of daily activities. \*Raisin meditation.

Other: Session 2: Mindfulness

Session 3: Our Perspectives on Ourselves and the World

EXPERIMENTAL

\*Breathing meditation. \*Habit Breaker: Watching the Sky.

Other: Session 3: Our Perspectives on Ourselves and the World

Session 4: Body Scan *Body scan meditation.

EXPERIMENTAL

\*Ten-finger gratitude practice. \*Habit Breaker: Spending some time in nature.

Other: Session 4: Body Scan *Body scan meditation.

Session 5: Recognizing Schizophrenia

EXPERIMENTAL

\*What is schizophrenia? \*What are its symptoms? \*What does treatment involve?

Other: Session 5: Recognizing Schizophrenia

Session 6: Mindful Movement

EXPERIMENTAL

\*Mindfulness movement meditation practice \*

Other: Session 6: Mindful Movement

Session 7: Mindful Breathing

EXPERIMENTAL

\*Breathing meditation

Other: Session 7: Mindful Breathing

Session 8: Treatment Evaluation

EXPERIMENTAL

\*The importance of medication \*Things to consider when using medication \*Side effects of medication \*What is a flare-up in schizophrenia? \*What are the precursor symptoms?

Other: Session 8: Treatment Evaluation

Session 9: Mindful Thinking

EXPERIMENTAL

\*Sounds and thoughts meditation \*Cinema activity.

Other: Session 9: Mindful Thinking

Session 10: Coping with Anger

EXPERIMENTAL

\*What is anger? \*What are its symptoms? \*What are the coping methods?

Other: Session 10: Coping with Anger

Session 11: Coping with Difficult Emotions

EXPERIMENTAL

\*Facing Difficulties meditation

Other: Session 11: Coping with Difficult Emotions

Session 12: Mindful Communication

EXPERIMENTAL

\*Communication \& mindful communication \*The importance of communication skills \*Fundamentals of communication, self-language practice \*Ways to prevent communication accidents

Other: Session 12: Mindful Communication

Session 13: Different Connections

EXPERIMENTAL

\*Breathing meditation. \*Habit Breaker: Thought and Emotional Play.

Other: Session 13: Different Connections

Session 14: The Joy of the Small Things

EXPERIMENTAL

\*Treasure Treasure Meditation \*Habit Breaker: Letter to Self.

Other: Session 14: The Joy of Small Things

Session 15: Dwelling on the Past or Living in the Present?

EXPERIMENTAL

\*Friendship-Building Meditation \*Habit Breaker: Random Acts of Kindness.

Other: Session 15: Dwelling on the Past or Living in the Present?

Session 16: Evaluation *Reinforcing What Has Been Learned.

EXPERIMENTAL

\*Evaluating the Program. \*Obtaining Feedback.

Other: Session 16: Evaluation

Group 2: 2: Recognizing the Illness

ACTIVE COMPARATOR

\*What is schizophrenia? \*What are its symptoms? \*What does treatment involve?

Other: Session 2: Group 2, Recognizing the Illness

Group 2: Session 3: Evaluating Treatment

ACTIVE COMPARATOR

\*Considerations regarding medication use \*Side effects of medication use \*Exacerbations in schizophrenia \*Premonitory symptoms.

Other: Session 3: Group 2, Treatment Evaluation

Group 2: Session 4: *What is anger?

ACTIVE COMPARATOR

\*What are the symptoms of anger? \*What are the methods for coping with anger?

Other: Session 4: Group 2, What is anger?

Group 2: Session 5: Communication *What is communication?

ACTIVE COMPARATOR

\*The importance of communication. \*Fundamentals of communication, self-language practice \*Ways to prevent communication difficulties.

Other: Session 5: Group 2, Communication

Group 2: Session 6: What is relaxation?

ACTIVE COMPARATOR

What is progressive relaxation. Relaxation CD introduction

Other: Session 6: Group 2, What is relaxation?

Group 2: Session 7: Relaxation

ACTIVE COMPARATOR

Performing the relaxation CD with patients

Other: Session 7: Group 2, Relaxation

Group 2: Session 8: Evaluation

ACTIVE COMPARATOR

\*Reinforcement of what has been learned. \*Evaluation of the program. \*Receiving feedback

Other: Session 8: Group 2, Evaluation

Group 2: Session 1: Preparatory Session

ACTIVE COMPARATOR

\*Meeting the patients \*Introducing the content of psychoeducation \*Emphasizing the importance of regular and timely attendance at training \*Determining training dates \*Sharing individuals' experiences and expectations

Other: Session 1: Group 2, Preparation Session

Interventions

\*Meeting the patients \*Introducing the content of mindfulness-based stress reduction training \*Emphasizing the importance of regular and timely attendance at training \*Determining training dates \*Sharing individuals' experiences and expectations

Session 1: Preparatory Session

\*What is mindfulness? \*Being aware of daily activities. \*Raisin meditation.

Session 2: Mindfulness

\*Breathing meditation. \*Habit Breaker: Watching the Sky.

Session 3: Our Perspectives on Ourselves and the World

\*Ten-finger gratitude practice. \*Habit Breaker: Spending some time in nature.

Session 4: Body Scan *Body scan meditation.

\*What is schizophrenia? \*What are its symptoms? \*What does treatment involve?

Session 5: Recognizing Schizophrenia

\*Mindfulness movement meditation practice \*

Session 6: Mindful Movement

\*Breathing meditation \*

Session 7: Mindful Breathing

\*The importance of medication \*Things to consider when using medication \*Side effects of medication \*What is a flare-up in schizophrenia? \*What are the precursor symptoms?

Session 8: Treatment Evaluation

\*Sounds and thoughts meditation \*Cinema activity.

Session 9: Mindful Thinking

\*What is anger? \*What are its symptoms? \*What are the coping methods?

Session 10: Coping with Anger

\*Facing Difficulties meditation \*

Session 11: Coping with Difficult Emotions

\*Communication \& mindful communication \*The importance of communication skills \*Fundamentals of communication, self-language practice \*Ways to prevent communication accidents

Session 12: Mindful Communication

\*Breathing meditation. \*Habit Breaker: Thought and Emotional Play.

Session 13: Different Connections

\*Treasure of Pleasure Meditation \*Habit Breaker: Letter to Self.

Session 14: The Joy of the Small Things

\*Friendship-Building Meditation \*Habit Breaker: Random Acts of Kindness.

Session 15: Dwelling on the Past or Living in the Present?

\*Reinforcing What Has Been Learned. \*Evaluating the Program. \*Obtaining Feedback.

Session 16: Evaluation *Reinforcing What Has Been Learned.

\*Meeting Patients \*Introducing the Content of Psychoeducation \*Emphasizing the Importance of Regular and Timely Attendance at Training \*Determining Training Dates \*Sharing Individuals' Experiences and Expectations

Also known as: Active Participant
Group 2: Session 1: Preparatory Session

\*What is Schizophrenia? \*What are its Symptoms? \*What Does Treatment Include?

Group 2: 2: Recognizing the Illness

\*Things to Consider When Using Medication \*Side Effects of Medication \*Exacerbation of Schizophrenia \*Precursor Symptoms.

Group 2: Session 3: Evaluating Treatment

\*What are the symptoms of anger? \*What are the methods for coping with anger?

Group 2: Session 4: *What is anger?

\*What is communication? \*The importance of communication. \*Fundamentals of communication, working on "I" language. \*Ways to prevent communication difficulties.

Group 2: Session 5: Communication *What is communication?

What is progressive relaxation? Introducing a relaxation CD

Group 2: Session 6: What is relaxation?

Practicing the relaxation CD with patients

Group 2: Session 7: Relaxation

\*Reinforcing what has been learned. \*Evaluating the program. \*Obtaining feedback

Group 2: Session 8: Evaluation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being registered with a CMHC
  • Being diagnosed with schizophrenia
  • Being between the ages of 18 and 60
  • Being willing to participate in the study
  • Being open to communication and cooperation
  • Being in remission

You may not qualify if:

  • Not being open to communication and cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Mine Cengiz lecturer doctor

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Physician

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

March 30, 2021

Primary Completion

December 15, 2021

Study Completion

March 15, 2022

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations