The effect of mindfulness-based cognitive therapy training on self-efficacy, rumination and resilience of family caregivers of cancer patients
Design
A randomized, non-blinded clinical trial with intervention and control groups on 90 family caregivers (45 in the intervention group and 45 in the control group) using Random Allocation software using a block random allocation method will be used for randomization. Given that the intervention is training in mindfulness techniques, the clinical trial phase is not applicable.
Settings and conduct
First, family caregivers of cancer patients in the oncology department of Imam Sajjad Hospital and the specialized clinic of the oncologist are selected using the convenience sampling method, considering the inclusion criteria. Then, they are divided into two intervention and control groups using the random assignment method. Interventions based on mindfulness-based cognitive therapy techniques are carried out in educational groups of fifteen people in the doctor's room of Imam Sajjad Hospital and the specialized clinic of the oncologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 years and older
Literacy
Fluency in Persian
Having a relative or causal relationship with the patient
Caring for only one patient
Not receiving a salary
Not being a member of the treatment staff
Caring for a patient with cancer for at least the past two months
Not participating in similar training courses at the time of study entry
Exclusion criteria:
History of mental health problems such as anxiety disorders and depression, as reported by caregivers
Unwillingness to participate in the study
Intervention groups
Participants will receive mindfulness techniques in groups of fifteen people, but in the control group participants will not receive any intervention.
Main outcome variables
self-efficacy
Rumination
Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260212068841N1
Registration date:2026-06-20, 1405/03/30
Registration timing:registered_while_recruiting
Last update:2026-06-20, 1405/03/30
Update count:0
Registration date
2026-06-20, 1405/03/30
Registrant information
Name
Reza Delfani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5266 5306
Email address
rdadlf3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-02, 1405/03/12
Expected recruitment end date
2026-09-03, 1405/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive therapy on self-efficacy and rumination and resilience on family caregiver of patient with cancer
Public title
Effect of Mindfulness on self-efficacy and rumination and resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and over
Being literate
Fluency in Persian
Having a relative or causal relationship with the patient
Caring for just one patient
Not receiving wages
Not being a member of the medical staff
Caring for a patient with cancer for at least the past two months
Failure to participate in similar training courses upon entering the study
Exclusion criteria:
History of mental health problems such as anxiety disorders and depression, as reported by caregivers
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two treatment and control groups using a block-wise random allocation method of equal size. The random sequence will be generated using a block-wise allocation method with a block size of four by Random Allocation software. Allocation concealment will be performed using sealed, numbered opaque envelopes. Each random sequence will be written on separate cards and the cards will be placed in sealed, opaque envelopes. These envelopes will be numbered sequentially and placed in a special box. When each participant enters, one of the envelopes will be opened in order and the desired group will be determined. This process will be carried out to ensure that the random allocation remains hidden until the participant enters the study, which is in accordance with CONSORT recommendations, a method to prevent bias in the randomization process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2026-04-22, 1405/02/02
Ethics committee reference number
IR.MUBABOL.HRI.REC.1405.071
Health conditions studied
1
Description of health condition studied
self-efficacy, rumination and resilience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions
Method of measurement
scherrer General Self-Efficacy Questionnaire
2
Description
Rumination
Timepoint
Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions
Method of measurement
Hoeksma and Maru Rumination Questionnaire
3
Description
Resilience
Timepoint
Before the start of the mindfulness training sessions, immediately, and two months after completing the eight mindfulness training sessions
Method of measurement
Connor and Davidson Resilience Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness techniques including conscious breathing, body scan, sitting meditation, conscious seeing and listening, and conscious walking will be taught in eight ninety-minute training sessions for eight consecutive weeks (one session per week) in groups of fifteen people. All educational materials provided will be presented in the sessions after the supervision and review of a psychiatrist. For the intervention group, the training program will be held in a group in the doctor's room of Imam Sajjad Hospital and the specialized clinic of an oncologist. The intervention will be carried out in the form of training and counseling. After each session, audio and video files, educational booklets, and weekly assignments will be provided to the participants.
Category
Behavior
2
Description
Control group: They will receive no educational intervention during the intervention period.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Sajjad Hospital
Full name of responsible person
Reza Delfani
Street address
Shahid Motahari Ave
City
Ramsar
Province
Mazandaran
Postal code
4691714143
Phone
+98 11 5522 2031
Email
hospitalimamsajjadramsar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi Rajabnia
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 0558
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Reza Delfani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4754131045
Phone
+98 991 225 5614
Email
rdadlf3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Abbas Shamsalinia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty of ramsar, Mottahari Ave
City
Ramsar
Province
Mazandaran
Postal code
4691714141
Phone
+98 11 5522 5151
Email
abbasshamsalinia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Delfani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Science, Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4754131045
Phone
+98 991 225 5614
Email
rdadlf3@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