NCT05245305

Brief Summary

This randomized controlled study evaluate the effect of the Mindfulness-Based Stress Reduction Program on the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients. The hypothesis of this study is that the Mindfulness-Based Stress Reduction Program improves the state-trait anxiety, hopelessness, self-compassion and care burden of the families of psychotic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 24, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

14 days

First QC Date

January 24, 2022

Last Update Submit

February 8, 2022

Conditions

MBSRCaregiver

Keywords

MBSRAnxietyHopelessnessCare burdenNursing

Outcome Measures

Primary Outcomes (1)

  • Anxiety will be evaluated using the State-Trait Anxiety Scale

    The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

    Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

Secondary Outcomes (4)

  • Care burden will be assessed using the Caregiver Burden Scale.

    Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

  • Hopelessness will be measured using the Beck Hopelessness Scale.

    Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

  • Self-compassion will be assessed using the Self-Compassion Scale.

    Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.

  • Focus Group Interview Questionnaire I

    Within 1 week postintervention

Study Arms (2)

MBSR Intervention

EXPERIMENTAL

The intervention group will take part in mindfulness-based stress reduction (MBSR) program led by a certified MBSR instructor via Zoom. The MBSR program was structured as 11 weeks, taking into account the characteristics of the participants.

Other: Mindfulness Based Stress Reduction Program

Control

NO INTERVENTION

No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.

Interventions

Mindfulness Based Stress Reduction ProgramOTHER

The intervention was structured as 11 weeks, taking into account the group. The program takes 2-2.5 hours per week. The program includes raisin exercise, body scanning meditation, breath awareness meditation, sitting meditation, mindfull movement, walking meditation, vision meditation, compassion meditation,mindfulness communication and day of silence.

Also known as: MBSR
MBSR Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years old
  • Able to read and understand Turkish
  • Taking care of the sick individual at home
  • Living in the same house with the sick individual
  • No psychiatric illness
  • No problems with movement, sight, hearing or understanding
  • Volunteer to participate in the study
  • Able to access the internet with their phone or computer
  • Those who did not receive any other psychological therapy during their working dates
  • No previous meditation experience
  • Having no practice in daily mind-body practices

You may not qualify if:

  • Under 18 years old
  • Can't read and understand Turkish
  • Any psychiatric illness receiving another psychological therapy on working dates
  • Meditation experience before the study; having practice in daily mind-body practices
  • Having problems with movement, vision, hearing, understanding
  • Not willing to participate in the study
  • Participants who participated in more than 50% of a mindfulness-based intervention prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (7)

  • Caqueo-Urizar A, Miranda-Castillo C, Lemos Giraldez S, Lee Maturana SL, Ramirez Perez M, Mascayano Tapia F. An updated review on burden on caregivers of schizophrenia patients. Psicothema. 2014 May;26(2):235-43. doi: 10.7334/psicothema2013.86.

    PMID: 24755026BACKGROUND

  • Liu Z, Chen QL, Sun YY. Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials. Clin Interv Aging. 2017 Sep 22;12:1521-1529. doi: 10.2147/CIA.S146213. eCollection 2017.

    PMID: 29026290BACKGROUND

  • Smith JM, Bright KS, Mader J, Smith J, Afzal AR, Patterson C, Dimitropolous G, Crowder R. A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders. Addict Behav. 2020 Apr;103:106223. doi: 10.1016/j.addbeh.2019.106223. Epub 2019 Nov 30.

    PMID: 31838440BACKGROUND

  • Stjernsward S, Hansson L. Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study. Inform Health Soc Care. 2017 Jan;42(1):97-108. doi: 10.1080/17538157.2016.1177533. Epub 2016 May 31.

    PMID: 27245198BACKGROUND

  • Williams H, Simmons LA, Tanabe P. Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control. J Holist Nurs. 2015 Sep;33(3):247-59. doi: 10.1177/0898010115569349. Epub 2015 Feb 11.

    PMID: 25673578BACKGROUND

  • Whitebird RR, Kreitzer M, Crain AL, Lewis BA, Hanson LR, Enstad CJ. Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Gerontologist. 2013 Aug;53(4):676-86. doi: 10.1093/geront/gns126. Epub 2012 Oct 15.

    PMID: 23070934BACKGROUND

  • Bogahan M, Yilmaz S, Yilmaz M. Effects of Mindfulness-Based Stress Reduction Program on the Mental Health and Care Burden in Family Caregivers of Individuals with Psychosis. Community Ment Health J. 2025 Oct 17. doi: 10.1007/s10597-025-01527-z. Online ahead of print.

    PMID: 41105316DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersCaregiver Burden

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Münevver Boğahan, Assistant

    Mersin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Münevver Boğahan, Assistant

CONTACT

+90 324 361 00 01 / 14238munevverbghn@hotmail.com

Münevver Münevver, Assistant

CONTACT

+90 324 361 00 01 / 14238munevverbghn@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
56 caregiver family members who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups by simple randomization by an independent researcher who is not included in the study. After the assignments, the statistician will put the 56 family members in which group in sealed envelopes and hand them over to the researcher. The researcher and participants will not know the intervention and control groups until they open the envelope at this stage (single blinding).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 17, 2022

Study Start

May 1, 2022

Primary Completion

May 15, 2022

Study Completion

February 28, 2023

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)