the aim of this study is to review and compare psychological training and reduce stress based on mindfulness on coping skills of caregivers with dementia
Design
Two arm parallel-group randomized trial of90 caregiver of a patient with dementia
Settings and conduct
90 caregivers for patients diagnosed with dementia who are eligible to participate in the study. As it has been explained before, participants will be divided into two experimental groups. The first group will be trained for mindfulness-based stress reduction methods in 8 sessions,1.5 hours each (22). The second group will receive psychological training in 8 sessions,1.5 hours each.
Participants/Inclusion and exclusion criteria
Inclusion criteria: participants include first (direct) caregiver of the Dementia patient, age range between 18-60 with reading and writing ability and NO cognitive ability impairments will attend the sessions. participants are not suffering from any disability or physical problems that may affect their mental health state, also participants’ informed consent will be obtained.
Intervention groups
psychoeduction
Mindfullness
Main outcome variables
Learning more about the disease and increase awareness by learning self-management techniques and increasing flexibility against mental problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161010030255N4
Registration date:2020-12-18, 1399/09/28
Registration timing:retrospective
Last update:2020-12-18, 1399/09/28
Update count:0
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Victoria Omranifard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
v_omranifard@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2020-10-16, 1399/07/25
Trial completion date
2020-12-16, 1399/09/26
Scientific title
A comparison of the effect of mindfulness-based stress reduction (MBSR) and psychoeducation on coping skills in caregivers of dementia patients
Public title
A comparison of the effect of mindfulness-based stress reduction (MBSR) and psychoeducation on coping skills in caregivers of dementia patients referred to a psychiatric clinic in Isfahan
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
First (direct) caregiver of the Dementia patient
The age between 18-60.
Reading and writing ability
lack of cognitive impairments
Ability to attending in the treatment sessions
lack of physical problems affecting their mental state,
Informed consent.
Exclusion criteria:
Participants should not require any medical treatment (i.e., pharmacological and non-pharmacological) between sessions
Absence for more than two sessions
Severe depression, psychosis, schizophrenia, bipolar disorder, or mental retardation
Drug addiction. ( that will be verified by the information available in the case file and interview)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomized using a list of computer-generated numbers, and the group assignments were concealed in an opaque sealed envelope until just before entry into the study. A total of 115consecutive patients with dementia were eligible for the study. 25 patients were excluded because they refused entry or did not meet the inclusion criteria. The 90 participants were assigned randomly and equally to one of the two training groups. The first training group received MBSR for 8 weeks. The second group received PE training during the first 8 weeks of the study. At enrolment, all careers had a pre-training evaluation that consisted of demographic data, complete medical history, physical and psychiatric examination.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street, Darvazeh Shiraz, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.MUI.MED.REC.1399.466
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
F00
ICD-10 code description
Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years.
Primary outcomes
1
Description
Changes in scores anxiety
Timepoint
Before intervention,after intervention ,after 3 month
Method of measurement
Questionnaire
2
Description
Change in score of depression
Timepoint
Before intervention,after intervention ,after 3 month
Method of measurement
Questionnaire
3
Description
Change in quality of life
Timepoint
Before intervention,after intervention ,after 3 month
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (Psychoeducation), Week 1 educational Presentations / What is Dementia? / Multi-sensory stimulation strategies: Olfaction Supportive Emotional impact on caregiving / Relaxation: Abdominal breathing Week 2 teaching/educating on Communication in Dementia; Multi-sensory stimulation strategies: Contact Supportive Deal with emotions / Relaxation: Stretching Week 3: teaching Multi-sensory stimulation strategies: Vision-Supportive Assertiveness / Relaxation: Guided imagery (purposeful/targeted pictures?)week 4: training/teaching/learning Multi-sensory stimulation strategies: Hearing- Social support (community support) /Relaxation: Progressive muscle relaxation technique Week5: teaching Multi-sensory stimulation strategies: Taste, Supportive Self-care / Relaxation: Autogenic technique week 6: teaching Elderly engagement: impossible mission? Supportive Problem-solving / Relaxation: Week7: Mitchell method teaching Challenging behaviors: How to cope with …? Supportive Cope with overcoming grief / Relaxation: Progressive muscle trainingWeek8: training to have a safer environment: What can we do? Celebration and closing session
Category
Behavior
2
Description
Intervention group, mindfulness: mindfulness, learning context for the rest of the experience. learning the theory and evidence of (medical/practitioner self/body-conscious) mind-body medicine and how to apply it. Introducing mindful (conscious) eating, mindful breathing, and the body-scanning method, focusing on what it means to be fully engaged in the present moment/current situation. week 2 learn to use the Body-scanning method to increase awareness about stress reactions. influencing the way someone perceives and responds to problems and challenges. The short- and long-term effects of stress on the individual mind and body. WEEK 3 practice several distinct and yet interrelated mindfulness methods, sitting meditation, and walking meditation. Investigate the process of expressing feelings like joy/pleasure or discomfort in mind and body.WEEK 4 the focus of the session is on the development of the ability to concentrate and expanding awareness systematically. learning the physiological and psychological bases of stress reactions (reactions under stress), and learning mindful strategies for positive and proactive respond in stressful situations.WEEK 5 pay attention to the places (situation) where you might get stuck in repetitive, unhealthy patterns that can (be managed) disarm through (by having) mindful awareness. Learn how to use mindfulness in a critical moment (situation) when we experience a physical sensation, intense emotion, or condition, using the method focus on exploring the effect of reactivity on individuals’ health and illness week 6 focus on transformational coping strategies to develop your inner resources and enhance flexibility using mindfulness practices. Learning the principles of interpersonal mindfulness—using (self/situational?) awareness and presence at times when interactions become difficult or are involved in strong emotions...WEEK 7 explore various ways to fully integrate mindfulness and bring a broader sense of awareness and presence into every moment in life and use non-judgmental mindfulness in self-reflection and decision-making processes.WEEK 8 A comprehensive review on all the content learned in this course; the final (session) lesson is to create a satisfying closure by honoring (celebrating) both the end of this program and the beginning of the rest of life
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Hospital of Isfahan
Full name of responsible person
Victoria Omranifard
Street address
khorshid Hospital
City
Isfahan
Province
Isfehan
Postal code
3414613155
Phone
+98 31 3222 2127
Fax
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghigh Gavanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street, Darvaze shiraz, Isfahan
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
med@mui.ac.ir
Web page address
https://mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Medical University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Victoria Omranifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Fax
+98 31 3222 2475
Email
v_omranifard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Victoria Omranifard
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Fax
+98 31 3222 2475
Email
v_omranifard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Victoria Omranifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Fax
+98 31 3222 2475
Email
v_omranifard@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected information/ data can be shared with other researchers after coding and deidentifying participants’ personal information.
When the data will become available and for how long
Start of the program; 6 months after the results are published in the valid journal
To whom data/document is available
Participants and researchers involved in this research and the scientific committee related to this research at the university
Under which criteria data/document could be used
In order to maintain confidentiality requirements, the data will not be made available to others except those that the university committees will request for scientific evaluation validity and reliability tests and revaluation
From where data/document is obtainable
If the data is needed by the abovementioned groups, they can contact the (chief officer )main executor of the project
What processes are involved for a request to access data/document
Contact the Vice-Chancellor for Research and then contact the executor of the main project chief officer