Protocol summary

Study aim
Determination of the effect of MICBT
Design
A clinical trial with a parallel control group, single-blind, randomized, phase 3 groups on 44 patients, for randomization from www. http://sealedenvelope.com/simple-randomiser/v1/lists was used
Settings and conduct
First, women who were diagnosed with infertility and met the criteria will be selected by purposive sampling from the center of Beheshti hospital in Kashan. At the first session of the researcher’s visit, all the information(methods, number of the sessions, duration, etc) randomization, the confidentiality of the information and the rights of withdrawal from the research will be provided. also, their consent of participation will be obtained. Individuals will then be randomly replaced in intervention and control groups of 22 people, and both groups will be identified in terms of all factors and confounding variables. Then treatment sessions will be held for people in the medical school.
Participants/Inclusion and exclusion criteria
Have a history of infertility for at least one year; one year applying for IVF infertility; treatment no history of experience in Cognitive-behavioral therapies and mindfulness; at least age 25 years old; Have the ability to read and write; marital satisfaction score 40 and below in the Enrich Questionnaire; psychological symptoms score 44 and above in the short form Questionnaire; psychological symptoms
Intervention groups
Treatment groups: 3 groups of 5 people and a group of 7 people for whom 8 sessions of MICBT treatment will be offered. also for the control group wiil be 4 sessions of developmental psychology.
Main outcome variables
Psychological symptoms, quality of life, marital satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220116053733N1
Registration date: 2022-01-27, 1400/11/07
Registration timing: prospective

Last update: 2022-01-27, 1400/11/07
Update count: 0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
seyed hossein معصومی لاری
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3285 1504
Email address
masoumi-sh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mindfulness integrated cognitive behavior therapy on psychological symptoms, quality of life and Marital Satisfaction in infertile women undergoing IVF treatment
Public title
The effectiveness of Mindfulness integrated cognitive behavior therapy on psychological symptoms, quality of life and Marital Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of infertility for at least one year one year applying for IVF infertility treatment no history of experience in Cognitive-behavioral therapies and mindfulness at least age 25 years old Have the ability to read and write marital satisfaction score 40 and below in the Enrich Questionnaire psychological symptoms score 44 and above in the short form Questionnaire psychological symptoms
Exclusion criteria:
Physical inability to perform exercises Use of drugs and other addictive substances
Age
From 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 44 (two groups of 22) and permuted block randomization method (block size=4) (11 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (44th person).
Blinding (investigator's opinion)
Single blinded
Blinding description
Consequences are with self-report tools so there is no need to blind the evaluator. The data is entered into SPSS software by the evaluator and by changing the names of the groups, the analyst will not be informed about the assigned treatment. After collecting the data, the names of the groups will be changed by the researcher.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.KAUMS.REC.1400.055

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Score of psychological symptoms in the short form questionnaire of psychological symptoms
Timepoint
Measurement of psychological symptoms before the intervention eight weeks after the start of the intervention and two months after the end of the intervention
Method of measurement
Short form of psychological symptoms questionnaire

2

Description
Global Health Quality of Life Questionnaire score
Timepoint
Measurement of quality of life before the intervention eight weeks after the start of the intervention and two months after the end of the intervention
Method of measurement
Global Health Quality of Life Questionnaire

3

Description
Marital Satisfaction Score in Enrich Marital Satisfaction Questionnaire
Timepoint
Measurement of marital satisfaction before the intervention eight weeks after the intervention and two months after the intervention
Method of measurement
Enrich Marital Satisfaction Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Structured 8-session treatment that is held according to the protocol for 90 minutes a week and teaches clients to internalize their attention in order to regulate their emotions and attention, and then externalize their regulated emotions and attention to manage their problems and use.
Category
Behavior

2

Description
Control group: In order to comply with ethical considerations, 4 sessions of developmental psychology training will be provided.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Center of Shahid Beheshti Hospital, Kashan
Full name of responsible person
Dr. Fatemeh Forouzanfard
Street address
Kashan University of Medical Sciences, Qutb Ravandi, Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5557 5999
Email
fatemehforoozanfard@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences, Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Web page address
http://kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Abdollah OMIDI
Position
Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
Abomidi20@yahoo.com
Web page address
http://Kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Hossein Masoumi Lari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
hmasoumi.psy@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Hossein Masoumi Lari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
hmasoumi.psy@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like and demographic information can be shared.
When the data will become available and for how long
The access period will be available 2 years after the results are published and up to one year later.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In case of any use, the names of the researchers of the project should be mentioned in the Thanksgiving section. No one has the right to use the data for non-human consumption, such as cases that endanger and endanger human life. Submitting an application must be in accordance with the academic procedure and will be reviewed for up to one month. Ask the person not to have any connection with anti-humanitarian and terrorist institutions.
From where data/document is obtainable
Seyed Hossein Masoumi Lari Kashan University of Medical Sciences School of Medicine hmasoumi.psy@yahoo.com
What processes are involved for a request to access data/document
According to the circumstances, it will be reviewed and answered by the person in charge.
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