Determining the Effect of Tele-Mindfulness Training on Resilience and Life Satisfaction of Family Caregivers of Individuals with Alzheimer’s Disease
Design
This study is a randomized, single-blind clinical trial with a control group and parallel groups, conducted on 84 caregivers. After assessing the inclusion criteria, eligible caregivers will be randomly assigned to two groups of 42 participants each.
Settings and conduct
Eligible participants will be randomly assigned to the intervention or control group. The intervention group will receive eight online mindfulness sessions, held twice weekly for 30 minutes, covering topics such as mindful breathing, body scanning, walking, and compassion. The control group will not receive any training. Data analysts will be blinded to group assignments.
Participants/Inclusion and exclusion criteria
Eligible participants must be 18 or older, be a family caregiver for an Alzheimer’s patient, and communicate effectively in Persian. They must provide at least four hours of daily care and not regularly engage in mindfulness practices. Participants should have no recent psychiatric diagnoses or history of substance abuse. A smartphone, internet access, and basic digital skills are required. Informed consent is mandatory.
Intervention groups
Family caregivers of individuals with Alzheimer's disease who visit the Iranian Dementia and Alzheimer's Association are screened based on the inclusion criteria.
Main outcome variables
Resilience and Life Satisfaction Questionnaire Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250129064562N1
Registration date:2025-04-23, 1404/02/03
Registration timing:registered_while_recruiting
Last update:2025-04-23, 1404/02/03
Update count:0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Zahra Mahdiniya arshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 4246
Email address
mehdiniyaarshad.z@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-03, 1404/01/14
Expected recruitment end date
2025-09-05, 1404/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of tele-mindfullness education on resiliance and life satisfaction of family caregivers of individuals with Alzheimer
Public title
Tele-mindfullness for family caregivers of individuals with Alzheimer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years old or above
Caregiver of a person with Alzheimer's
Family member of the patient
Must possess effective communication skills in Persian
Must provide direct daily care for a minimum of four hours
Exclusion criteria:
Not having informed consent for participation in the research study
Not Having enough proficiency in using a smartphone or tablet for messaging, attending classes, and downloading files
Not owning a smartphone and have reliable internet access for participation in online sessions
Having a history of substance or medication abuse
Having a recently diagnosed psychiatric disorder such as severe depression, anxiety disorder, or psychosis
Engaging in a regular mindfulness meditation, mindful yoga, or enrolled in a similar mindfulness-based program
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
To maintain consistent research environment conditions between the control and experimental groups, the random allocation of samples into the control and intervention groups will be performed in an alternating manner. For the assignment of the first sample, a coin toss will be employed to determine placement in either the control or intervention group. Subsequent samples will be alternately allocated to the corresponding groups. Sampling will continue until the required sample size, as determined by the specified formula, is achieved.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data analysts are blinded to the placement of caregivers in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Working Group of the Vice-Chancellor for Research and Technology at Iran Univers
Street address
Deputy for Research and Technology, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
IR.IUMS.REC.1403.407
Health conditions studied
1
Description of health condition studied
Caregiving for individual with Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
The score of resilience
Timepoint
Before and after the intervention
Method of measurement
Resilience Questionnaire for In-home Caregivers of the Elderly
2
Description
Life Satisfaction Score
Timepoint
Before and after the intervention
Method of measurement
Satisfaction with life scale (SWLS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The educational content for the intervention group is designed to provide mindfulness training for family caregivers of individuals with Alzheimer's disease. The training will be delivered over eight 30-minute sessions, conducted twice weekly over four weeks. Session topics include an introduction to mindfulness and mindful raisin eating (Session 1), mindful breathing (Session 2), mindful body scanning (Session 3), mindful seeing and listening (Session 4), mindful walking (Session 5), mindful sitting (Session 6), mindful compassion (Session 7), and a concluding session (Session 8). Additionally, participant experiences will be discussed throughout the sessions.
Category
Behavior
2
Description
Control group: After completing the study and analyzing the data, to maintain ethical principles, electronic pamphlets on mindfulness training (which were sent to the intervention group at the end of each session) will be provided to the control group (sent electronically to their respective groups). The researcher will also answer their questions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Dementia and Alzheimer's Association
Full name of responsible person
Masoumeh Salehi
Street address
Opposite District 6 Municipality, at the beginning of the exit toward North Sattari, Basij Square, Ekbatan Town, Tehran.
City
Tehran
Province
Tehran
Postal code
1396956144
Phone
+98 21 4467 3332
Email
alzheimer.iran@yahoo.com
Web page address
https://iranalz.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
info@iums.ac.ir
Web page address
https://en-vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Raziye Sadat Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 6074
Email
Ra.Hosseiny@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Raziye Sadat Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 6574
Email
Ra.Hosseiny@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Mahdiniya Arshad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Rashid Yasemi St. Valiasr St. Tehran- Iran
City
Tehran
Province
Tehran
Postal code
88201978
Phone
+98 21 4365 1000
Email
zahra.mehdiniya.id@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available