The Effects of Group and Individual Mindfulness-Based Cognitive Therapy on Happiness of Postmenopausal Women will be compaired.
Design
Random counseling intervention is controlled by pre-test, post-test and follow-up.
Settings and conduct
Sampling is done in Sadi health centers of Ahvaz and is randomized in blocks.Group and Individual Mindfulness-Based Cognitive Therapy will be conducted for the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes obtaining score lower than the cutoff score(40-42) from Happiness scale and scores 11-18 base on Beck Depression Inventory as mild depression, potential menopausal women aged 50-64 years, menopaused 1-5 years ago, basic literacy and willingness to cooperate in the study and exclusion criteria includes history of a medical disorders or physical motor disability, history of psychological and cognitive disorders that needed medication, smoking and substance abuse, mourning or having critical events during last 3 months and participating in any counseling programs during last year.
Intervention groups
24 of participants are located in group intervention that will be divided into two groups of 12 people. Mindfulness-Based Cognitive Therapy Intervention will be held for them as 90 minutes group sessions weekly for 8 weeks. Another 24 of participants will be in individual intervention part that intervention will be held for them as 90 minutes individual sessions weekly for 8 weeks.
Main outcome variables
Happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058911N1
Registration date:2023-08-21, 1402/05/30
Registration timing:prospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Basad Terikani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2772
Email address
terikani.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-18, 1402/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Group and Individual Mindfulness-Based Cognitive Therapy on Happiness of Postmenopausal Women
Public title
the Effects of Group and Individual Mindfulness-Based Cognitive Therapy on Happiness of Postmenopausal Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
obtaining score lower than the cutoff score(40-42) from Happiness scale and scores 11-18 base on Beck Depression Inventory as mild depression
potential menopause women aged 50-64 year
menopaused 1-5 years ago
basic literacy
willingness to cooperate in the study
Exclusion criteria:
history of a medical disorders such as or physical motor disability
history of psychological and cognitive disorders that needed medication
smoking and substance abuse
mourning or having critical events during last 3 months
participating in any MBCT program during last year
Age
From 50 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be block type. 12 blocks with a volume of 4 are used. In each block, two allocations for the group intervention and two allocations for the individual intervention are considered. Random sequencing will be generated by web-based randomization using the site (https://www.sealedenvelope.com). The generated sequence will also be centrally hidden so that the list of random assignment sequences is provided to someone outside the research team. As soon as a person is eligible to participate in the study, the researcher or sampler will contact the person who has the random assignment sequence and he or she will code the participants to enter the study according to the sequence list.
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 of Ahvaz Jundishapoor University of Medical Sciences
Street address
Central Organization Building , Esfand Ave , Golestan Blvd , Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2023-07-24, 1402/05/02
Ethics committee reference number
IR.AJUMS.REC.1402.255
Health conditions studied
1
Description of health condition studied
Happiness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Happiness
Timepoint
pre- test, post test and follow up 4 weeks after intervention
Method of measurement
Oxford Happiness Inventory
Secondary outcomes
empty
Intervention groups
1
Description
24 of participants are located in group intervention that will be divided into two groups of 12 people. Mindfulness-Based Cognitive Therapy Intervention will be held for them as 90 minutes group sessions weekly for 8 weeks.
Category
Behavior
2
Description
Intervention group: Another 24 of participants will be in an individual intervention that intervention will be held for them as 90 minutes individual sessions weekly for 8 weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Saadi health center of Ahvaz
Full name of responsible person
Basaad Terikani
Street address
No. 138, St. 5, 22 Bahman Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6134995959
Phone
+98 916 602 8493
Email
bterikan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Research building, Ahvaz University Of Science ,Esfand Ave , Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Basaad Terikani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 138, St. 5, 22 Bahman Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6134995959
Phone
+98 916 602 8493
Email
bterikan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, Esfand Ave , Golestan Blvd , Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
parvinabedi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Basaad Terikani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 138, St. 5, 22 Bahman Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6134995959
Phone
+98 916 602 8493
Fax
Email
bterikan@gmail.com
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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data is potentially shareable after unidentified individuals
When the data will become available and for how long
After finishing the study and publishing in a reputable journal
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for future studies
From where data/document is obtainable
Sending an email to corresponding author: parvinabedi@ymail.com
What processes are involved for a request to access data/document
sending an email to the corresponding author. The request will be answered after a month.