effect of premarital program on reducing ocd symptoms after childbirth
Design
Clinical trials with control groups, with parallel groups, two blind, randomised
Settings and conduct
After the groups become clear, eight training sessions for pregnant mothers at Avicenna " s psychiatric hospital or the centre of health are being established. The participants did not know the contents of the training programme. Before and after the training, the assessment is followed up to eight weeks after the birth.
Participants/Inclusion and exclusion criteria
Pregnant women ages 20 to 35, the first pregnancy and have no miscarriage and infertility.
Intervention groups
intervention group:
8 sessions training of CBT prevention OCS
control group:8 sessions of education of child developmental stage
Main outcome variables
severity of symptoms , depression and obsessive beliefs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040985N1
Registration date:2019-10-23, 1398/08/01
Registration timing:prospective
Last update:2019-10-23, 1398/08/01
Update count:0
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Fatemeh Fatemifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2691
Email address
fatemifarf5@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the prevention program obsessive - compulsive symptoms (OCS) on the emergence of these symptoms after childbirth.
Public title
Training OCD prevention program
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 35
gestation period before 12 weeks (first quarter)
first pregnancy
No history of abortion or infertility
natural pregnancy
No history of special physical illness
they don't take special medication
higher scores 139 in obsessive beliefs questionnaire(QBO)
No clinical diagnosis OCD
Exclusion criteria:
having Specific medical conditions
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The random sampling method with the variable block size, which is a multiple of 2, will be used. The size will be at least 4 for the non - predictability of individuals to be allocated to groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants do not know the difference in educational content of the two groups .
Raters don 't know what group they are in.
Placebo
Not used
Assignment
Parallel
Other design features
It is the first time that the intervention is done with the aim of determining the symptoms after delivery .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
St Daneshghah-Daneshghah 18
City
Mashhad
Province
Razavi Khorasan
Postal code
9195893134
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.306
Health conditions studied
1
Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
The intensity of the obsessive, depression, and obsessive - compulsive beliefs
Timepoint
before and after the end of training the week and eight weeks after childbirth.
Method of measurement
Comparison of the scores of questionnaires.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training obsessive compulsive symptoms prevention program
Category
Prevention
2
Description
Control group: Education of children's developmental characteristics from birth to 5 years old
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center of City Mashhad
Full name of responsible person
Fatemeh Fatemifar
Street address
Blv hor ameli- ebn sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2540
Email
Fatemifarf5@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Psychiatry and Behavioral sciences Research Center
Street address
blv hor ameli- ebn sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2540
Email
pbsrc@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Fatemifar
Position
پژوهشگر
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
blv hor ameli- ebnsina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2540
Email
fatemifarf5@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad reza fayyazi bordbar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Blvd hor ameli- ebn sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2540
Email
fayyazimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fatemeh fatemifar
Position
researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Blvd hor ameli- ebn sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2540
Email
fatemifarf5@mums.ac.ir
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
Yes - There is 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
The full statistical report will be published in detail on the data of the questionnaires in the paper.
When the data will become available and for how long
from 2020
To whom data/document is available
The data report will be published in the article.
Under which criteria data/document could be used
The data report will be published in the article.
From where data/document is obtainable
The data report will be published in the article.
What processes are involved for a request to access data/document