Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05245305
Status:
UNKNOWN
Last Update Posted:
2022-02-17
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Mindfulness-Based Stress Reduction Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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).'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, parallel, two-arm randomized controlled clinical trial Masking: Single (Participant)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}], 'secondaryOutcomes': [{'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.', 'description': 'A score between 22 and 110 is taken from the scale. Obtained points; It is evaluated by grading as "light load" between 22-46, "medium load" between 47-55, "severe load" between 56-110.'}, {'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.', 'description': 'The score range of the scale is 0-20. When the scores obtained are high, hopelessness in the individual is considered high'}, {'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.', 'description': 'To calculate the total self-compassion score, the "self-judgmental", "social isolation" and "over-identification" subscale items are reverse coded.\n\nThen, the self-compassion level is calculated by taking the average of all the items.\n\nThe higher the score for each sub-dimension, the higher the level of self-compassion.'}, {'measure': 'Focus Group Interview Questionnaire I', 'timeFrame': 'Within 1 week postintervention', 'description': 'Focus Group Interview Questionnaire I was created by the researcher in order to evaluate the experiences of the individuals in the study group regarding the MBSR program. There are five questions in the form.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MBSR', 'Anxiety', 'Hopelessness', 'Care burden', 'Nursing'], 'conditions': ['MBSR', 'Caregiver']}, 'referencesModule': {'references': [{'pmid': '24755026', 'type': 'BACKGROUND', 'citation': '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': '29026290', 'type': 'BACKGROUND', 'citation': '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': '31838440', 'type': 'BACKGROUND', 'citation': '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': '27245198', 'type': 'BACKGROUND', '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.'}, {'pmid': '25673578', 'type': 'BACKGROUND', '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.'}, {'pmid': '23070934', 'type': 'BACKGROUND', '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.'}, {'pmid': '41105316', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/24755026/', 'label': 'An updated review on burden on caregivers of schizophrenia patients'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29026290/', 'label': 'Mindfulness training for psychological stress in family caregivers of persons with dementia: a systematic review and meta-analysis of randomized controlled trials'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31838440/', 'label': 'A pilot of a mindfulness based stress reduction intervention for female caregivers of youth who are experiencing substance use disorders'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27245198/', 'label': 'Outcome of a web-based mindfulness intervention for families living with mental illness - A feasibility study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25673578/', 'label': 'Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/23070934/', 'label': 'Mindfulness-based stress reduction for family caregivers: a randomized controlled trial'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMethods: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Above 18 years old\n* Able to read and understand Turkish\n* Taking care of the sick individual at home\n* Living in the same house with the sick individual\n* No psychiatric illness\n* No problems with movement, sight, hearing or understanding\n* Volunteer to participate in the study\n* Able to access the internet with their phone or computer\n* Those who did not receive any other psychological therapy during their working dates\n* No previous meditation experience\n* Having no practice in daily mind-body practices\n\nExclusion Criteria:\n\n* Under 18 years old\n* Can't read and understand Turkish\n* Any psychiatric illness receiving another psychological therapy on working dates\n* Meditation experience before the study; having practice in daily mind-body practices\n* Having problems with movement, vision, hearing, understanding\n* Not willing to participate in the study\n* Participants who participated in more than 50% of a mindfulness-based intervention prior to the study"}, 'identificationModule': {'nctId': 'NCT05245305', 'acronym': 'Mindfulness', 'briefTitle': 'The Effect of Mindfulness-Based Stress Reduction Program', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': "The Effect of Mindfulness-Based Stress Reduction Program on Mental Status and Care Burden of Psychotic Patients' Families", 'orgStudyIdInfo': {'id': 'munevverbghn'}, 'secondaryIdInfos': [{'id': 'Münevver Boğahan', 'type': 'REGISTRY', 'domain': 'Münevver Boğahan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBSR Intervention', 'description': '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.', 'interventionNames': ['Other: Mindfulness Based Stress Reduction Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention was applied to the control group. Data will be collected from the control group simultaneously with the study group.'}], 'interventions': [{'name': 'Mindfulness Based Stress Reduction Program', 'type': 'OTHER', 'otherNames': ['MBSR'], 'description': '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.', 'armGroupLabels': ['MBSR Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33343', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Münevver Boğahan, Research assistant', 'role': 'CONTACT', 'email': 'munevverbghn@hotmail.com', 'phone': '+90 324 361 00 01 / 14238'}, {'name': 'Serpil Türkleş, Associate professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mualla Yılmaz, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Münevver Boğahan, Assistant', 'role': 'CONTACT', 'email': 'munevverbghn@hotmail.com', 'phone': '+90 324 361 00 01 / 14238'}, {'name': 'Münevver Münevver, Assistant', 'role': 'CONTACT', 'email': 'munevverbghn@hotmail.com', 'phone': '+90 324 361 00 01 / 14238'}], 'overallOfficials': [{'name': 'Münevver Boğahan, Assistant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Munevver Bogahan', 'investigatorAffiliation': 'Mersin University'}}}}