Comparing the Effectiveness of Cognitive Behavioural Therapy in Individual and Couple Settings on Negative Emotional States, Fertility Problem and Pregnancy Rate in Infertile Women
This trial aims to compare the effectiveness of two methods of delivering cognitive behavioral therapy (individual and couples) on negative emotional states, fertility problem, and pregnancy rate in infertile women seeking assisted reproductive treatment.
Design
A controlled clinical trial with parallel groups, single-blind, randomized, on 100 participants, using the website http://www.Randomiszation.com for randomization.
Settings and conduct
The intervention will be conducted at the Milad Infertility Clinic located at Imam Reza Hospital in Mashhad. Clients who complete an informed consent form will be randomly assigned to one of three groups, with the experimental group receiving a course of cognitive behavioral therapy, either individually or in pairs, delivered by a trained therapist. The control group does not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Couples who are candidates for In vitro fertilization(IVF) or
Intracytoplasmic sperm injection(ICSI).
Age less than 40 years
Must have at least a middle school education.
Not taking psychiatric medications
No history of suicide
The couple's karyotype should be normal.
The criteria for not entering the trial are also receiving other psychological treatment at the same time, not being physically or mentally fit enough to answer the questionnaires or attend the meetings.
Intervention groups
This clinical trial consists of two experimental groups and a control group. The experimental groups receive a course of cognitive behavioral therapy individually or in pairs, and The control group does not receive any intervention.
Comparing the Effectiveness of Cognitive Behavioural Therapy in Individual and Couple Settings on Negative Emotional States, Fertility Problem and Pregnancy Rate in Infertile Women
Public title
Comparing the Effectiveness of Individual Cognitive Behavioural Therapy and Couple Cognitive Behavioural Therapy on Negative Emotional States, Fertility Problem and Pregnancy Rate in Infertile Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be under 40 years of age.
Follicle-stimulating hormone is less than 10.
Body mass index is less than 30.
Must have at least a middle school education.
Not taking psychiatric medications
No history of suicide
The patient does not have Uterine abnormalities or thrombophilia.
The couple's karyotype should be normal.
There is no strong male factor in infertility.
Couples who are candidates for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Exclusion criteria:
Receiving other psychological treatment at the same time
Not being physically or mentally fit to answer questionnaires or attend meetings
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who meet the criteria for entering the project and have filled out the informed consent form will be randomly placed into three groups (experimental group one (individual CBT), experimental group two (couple CBT), and control group). It should be noted that the web-based randomization method and the site http://www.Randomiszation.com are used to randomly assign individuals to groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and clinical caregiver are not blinded to the experiment, but the person analyzing the data is blinded to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Depression, anxiety, and stress scores in the Depression Anxiety Stress Scalls-21
Timepoint
Measurement of Negative Emotional States before the start of the intervention and 60 days later (immediately after the end of the intervention)
Method of measurement
Depression Anxiety Stress Scalls-21
2
Description
Infertility-related stress score on the Fertility Problem Questionnaire
Timepoint
Measurement of infertility-related stress before the intervention began and 60 days later (immediately after the intervention ended)
Method of measurement
Fertility Problem Questionnaire
Secondary outcomes
1
Description
chemical Pregnancy
Timepoint
Two weeks after assisted reproductive treatment or one month after completing cognitive behavioral therapy
Method of measurement
Gonadotropin hormone measurement through blood test
Intervention groups
1
Description
First intervention group: Individual cognitive behavioral therapy. This psychological therapy is provided in 10 sessions and its components include identifying and correcting cognitive biases and ineffective emotion regulation strategies.
Category
Behavior
2
Description
Second intervention group: Cognitive behavioral couple therapy. This psychological therapy is provided in 10 sessions and its components include training in communication skills, problem solving, expressing emotions, cognitive restructuring, tolerance, and acceptance.
Category
Behavior
3
Description
Control group: This group does not receive any intervention and is placed on a waiting list.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Clinic, Imam Reza Hospital
Full name of responsible person
Seyede Maryam Sedaghat
Street address
NO. Ebne Sina St., Mashhad., Razavi Khorasan Province
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Alireza Saidi
Street address
Vice Chancellor for Research and Technology., Shahid Bahonar University.,Pazhohesh Sq., Imam Khomeini Hwy., Kerman
City
Kerman
Province
Razavi Khorasan
Postal code
7616913439
Phone
+98 34 3132 3011
Email
saidi@uk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Bahonar University of Kerman
Proportion provided by this source
50
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
Shahid Bahonar University of Kerman
Full name of responsible person
Maryam Sedaghat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 29, 21/10 Hedayat St., Hedayat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9194994416
Phone
+98 51 3753 7986
Fax
Email
samse@uk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Seyed Mohammad Hossein Mousavi-Nasab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology., Faculty of Literature and Humanities., Shahid Bahonar University., Pazhohesh Square., Imam Khomeini Highway., Kerman., Iran.
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 2393
Fax
Email
hossein.mousavi-nasab@uk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Maryam Sedaghat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 29, 21/10 Hedayat St., Hedayat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9194994416
Phone
+98 51 3753 7986
Fax
Email
samse@uk.ac.ir
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