Clinical trial NCT05245305: The Effect of Mindfulness-Based Stress Reduction Program
Official title: The Effect of Mindfulness-Based Stress Reduction Program on Mental Status and Care Burden of Psychotic Patients' Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MBSR
Caregiver
Keywords: MBSR
Anxiety
Hopelessness
Care burden
Nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Introduction: One of the chronic mental diseases, psychosis causes social and economic losses by negatively affecting the patient's feelings, thoughts and behaviors, interpersonal relations, work and social harmony, and the patient and family may experience different difficulties. With the transition to the community-based model in the provision of mental health services, the relatives of the patients have become the primary caregivers in the care of the patient and their responsibilities have increased even more.When the family is considered as a system, there is a constant interaction between the parts of the system and the change in the patient in case of illness can affect the whole family.When the disease occurs, one of the family members has to take care of the sick individual and caregivers experience emotional (decreased self-esteem, restlessness, depression, insomnia, social isolation, etc.), social (restriction of entertaining, relaxing and leisure time activities, reduction in the role of self-care, etc.). ) and economically (expenses not covered by social security creating an additional burden, reducing working hours, etc.). It is emphasized that psychosocial interventions for families increase the perception of social support, self-efficacy and satisfaction with treatment among caregivers, and reduce the perceived burden and recurrence of the disease.However, the high level of emotional expression and perceived stress of the families may trigger the recurrence of the disease. For this reason, family is naturally emphasized as an important factor in the recovery of the individual with a psychotic illness. Therefore, rehabilitation processes should be aimed not only at patients, but also towards caregivers. One of the interventions used for this purpose today is the Mindfulness-Based Stress Reduction (MBSR) program, which is an evidence-based intervention that teaches skills to reduce stress and manage challenging emotions in a group setting. Although the MBSR intervention is usually aimed at people with chronic physical and mental illnesses, the purpose of the intervention is not to replace medical treatment, but can be used as a supplement, supportive, preventive, complementary or simply a stand-alone method to heal patients. In this respect, it is thought that it is important for psychiatric nurses to use the MBSR program, which is a complementary, supportive, preventive and protective program, in the protection and strengthening of mental health in family members who care for psychosis patients. When the literature is examined, it is emphasized that the MBSR program has positive effects on caregiver family members. In this context, this study is planned to determine 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.

Methods: In the study, 60 family members caring for an individual with psychotic illness were randomly assigned to the study and control groups. 11-week MBSR program will be apply to study group (n = 28). No intervention will be made to the control group (n = 28). The primary outcome of the study is the effect of MBSR on the state-trait anxiety, hopelessness, and self-compassion levels of caregiver family members. The secondary outcome of the study is the effect of MBSR on the caregiving burden of family members. Data will be collected pre-intervention, post-intervention, 3 and 6 months after the intervention.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anxiety will be evaluated using the State-Trait Anxiety Scale
timeFrame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
Secondary outcomes:
measure: Care burden will be assessed using the Caregiver Burden Scale.
timeFrame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
measure: Hopelessness will be measured using the Beck Hopelessness Scale.
timeFrame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
measure: Self-compassion will be assessed using the Self-Compassion Scale.
timeFrame: Change from preintervention, on average 1 week upon completion of the intervention, 3 months and 6 months after the intervention.
measure: Focus Group Interview Questionnaire I
timeFrame: Within 1 week postintervention
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Mersin University
name: Münevver Boğahan, Assistant
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.