Effectiveness of internet-based cognitive behavioral therapy in reduction of anxiety/depression of infertile women
Design
A non-inferiority randomized controlled clinical trial with two parallel arms
Settings and conduct
This study will be conducted on infertile women who referring to Fatemeh Zahra infertility center. Infertile women with anxiety/ depression allocate randomly into two experimental groups. The participants of group A (30 persons) will be receive online cognitive behavioral therapy. The participants of group B (30 persons) receive individually face-to-face cognitive behavioral therapy. The contents and structures of two groups are same duration of 8 sessions, once a week, lasting 50 minutes. All patients of two groups will be filled four questionnaires including; 9-questions patient's health questionnaire (PHQ-9), Beck Depression questionnaire, Beck Anxiety questionnaire, Fertility problem inventory and covid-19 anxiety at the beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) .
Participants/Inclusion and exclusion criteria
inclusion criteria: aged 19-45 years, more than five years of education, based on Beck's questionnaire meeting the criteria for mild to moderate depression (between 14 to 49); did not receive any medication or counseling, have access to computers and the Internet, have access to a telephone that is always able to respond. Exclusion criteria include: unwillingness to participate in the study, severe depression, and the existence of suicidal ideation.
Intervention groups
Intervention group A will be received online cognitive behavioral therapy. Intervention group B receives individually face-to face cognitive behavioral therapy. The duration of treatment for both groups is similar, 8 sessions, once a week for 50 minutes.
Main outcome variables
Anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N9
Registration date:2020-12-08, 1399/09/18
Registration timing:registered_while_recruiting
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of internet-based cognitive behavioral therapy in reduction of anxiety/depression of infertile women
Public title
Effectiveness of internet psychotherapy in reduction of anxiety/depression of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 19-45 years
More than five years of education
Based on Beck's questionnaire meeting the criteria for mild to moderate depression (between 14 to 49)
Did not receive any medication or counseling
Have access to computers and the Internet
Have access to a telephone that is always able to respond
Exclusion criteria:
Unwillingness to participate in the study
Severe depression
The existence of suicidal ideation
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After checking inclusion and exclusion criteria, participants are allocate randomly into two groups by permuted block randomization method. The block size is 4 and by using the statistical software, 4 part blocks will be produced 15 times. One samples of 60-list will be produced. Using this randomly generated list, participants are divided into two groups of 30 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A non-inferiority randomized controlled clinical trial with two parallel arms
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development (NIMAD)
Street address
National Institute for Development of Medical Research (NIMAD), No. 21, Besat St., West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.NIMAD.REC.1398.174
Health conditions studied
1
Description of health condition studied
Anxiety and depression
ICD-10 code
F41.2
ICD-10 code description
mixed anxiety and depressive disorder
Primary outcomes
1
Description
Anxiety
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months
Method of measurement
Beck Anxiety questionnaire
2
Description
Depression
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2)
Method of measurement
Beck depression questionnaire
Secondary outcomes
1
Description
Patient’s health
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2)
Method of measurement
9-questions patient's health questionnaire (PHQ-9)
2
Description
Infertility stress
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2)
Method of measurement
Fertility problem inventory
3
Description
Covid-19 anxiety
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months
Method of measurement
Covid-19 anxiety questionnaire
4
Description
Patient treatment satisfaction
Timepoint
beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months
Method of measurement
Patient treatment satisfaction questionnaire
Intervention groups
1
Description
Intervention group A: The participants in this group receive online cognitive behavioral therapy once a week, 8 session 50 minutes.
Category
Treatment - Other
2
Description
Intervention group B: Participants in this group receive individually face-to- face cognitive behavioral therapy, once a week 8 sessions 50 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Fertiluty and Infertility Center
Full name of responsible person
Dr. Zahra Basirat
Street address
Fatemeh Al-Zahra Infertility Center, Tork Mahalle, Amol-Babol Road, Babol City, Mazandaran Province ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3227 4880
Email
Zahra_basirat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development (NIMAD)
Full name of responsible person
mahboobe faramarzi
Street address
National Institute for Development of Medical Research (NIMAD), No. 21, Besat St., West Fatemi St., Tehran, Iran
City
Tehran
Province
Mazandaran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 11 1329 4456
Email
mahbob330@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development (NIMAD)
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Farzan Kheyrkhah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 911 112 8368
Email
drfarzankh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Farzan Kheirkhah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 911 112 8368
Email
drfarzankh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
shiva shafie rizi
Position
student
Latest degree
Master
Other areas of specialty/work
Counseling in Midwifery
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 913 423 7661
Email
shiva0shafie@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