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Comparison of effect of compute-based versus face- to-face cognitive behavioral therapy for improvement of symptoms of adjustment disorders in infertile women

Protocol summary

Study aim
Comparison of the effectiveness of computerized cognitive behavioral therapy with face-to-face cognitive behavioral therapy in improvement of symptoms of adjustment disorders among infertile women
Design
A non-inferiority randomized controlled clinical trial with two parallel arms
Settings and conduct
Infertile women diagnosed as adjustment disorder referred to Fatemeh Zahra infertility center and Mehregan, allocate randomly into two experimental groups.The participants of intervention group 1 will be receive computerized cognitive behavioral therapy and intervention group 2 receive 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 questionnaires Symptoms of adjustment disorder, Hospital anxiety and depression scale, Fertility problem inventory, and Infertility Adjustment Scale, at the beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention, 3 months and 6 months follow-ups. a person who is not in research team, will be assessed the outcomes of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 18 years old, at least a third year of middle school, Internet access and the ability to use a computer, not using psychotherapy services right now. Exclusion criteria: people with mental disabilities, severe psychiatric disorders such as severe depression, psychotic disorder, bipolar disorder, suicide risk, drug abuse...
Intervention groups
Intervention group A will be received computerized 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
Symptoms of adjustment disorder, Depression, anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110228005931N8
Registration date: 2020-07-22, 1399/05/01
Registration timing: prospective

Last update: 2020-07-22, 1399/05/01
Update count: 0
Registration date
2020-07-22, 1399/05/01
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
2020-09-22, 1399/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of compute-based versus face- to-face cognitive behavioral therapy for improvement of symptoms of adjustment disorders in infertile women
Public title
Efficacy of computer-based vs face-to face cognitive behavioral therapy in infertile women with adjustment disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old At least a third year of middle school Internet access and the ability to use of computer No current psychotherapy services
Exclusion criteria:
People with mental disabilities Severe psychiatric disorders such as severe depression Psychotic disorder Bipolar disorder Suicide risk Drug abuse
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
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 38 times. Due to the fact that sampling is done in two centers, two samples of 152-list will be produced. Using this randomly generated list, participants are divided into two groups of 76 people.
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
Ethic committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1399.105

Health conditions studied

1

Description of health condition studied
Adjustment disorder
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders

Primary outcomes

1

Description
Symptoms of adaptive disorder
Timepoint
Before the intervention, the fourth week after beginning the intervention, at end of the intervention, and follow- ups of 3 and 6 months after the end of intervention
Method of measurement
Adjustment disorder

2

Description
Anxiety
Timepoint
Before the intervention, the fourth week after beginning the intervention, at end of the intervention, and follow- ups of 3 and 6 months after the end of intervention
Method of measurement
Hospital anxiety and depression scale

3

Description
Depression
Timepoint
Before the intervention, the fourth week after beginning the intervention, at end of the intervention, and follow- ups of 3 and 6 months after the end of intervention
Method of measurement
Hospital anxiety and depression scale

Secondary outcomes

1

Description
Infertility stress
Timepoint
Before the intervention, at end of the intervention, and follow- up 6 months after the end of intervention
Method of measurement
Fertility problem inventory

2

Description
Infertility adjustment
Timepoint
Before the intervention, at end of the intervention, and follow- up of 6 months after the end of intervention
Method of measurement
Infertility Adjustment Scale

Intervention groups

1

Description
Intervention group 1: The participants in this group receive computerized cognitive behavioral therapy 8 session during two month, 50 minutes, once a week.
Category
Treatment - Other

2

Description
Intervention group 2: Participants in this group receive individually face-to- face cognitive behavioral therapy, 8 sessions during two month 50 minutes, once a week.
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

2

Recruitment center
Name of recruitment center
Mehregan private hospital
Full name of responsible person
Dr. Zahra Basirat
Street address
Mehregan private hospital, Amirkala, Imam Reza Boulevard, Babol city, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3239 5591
Email
Zahra_basirat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
r.ghadimi@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com

Person responsible for scientific 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

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more informatiom
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
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