Objectives: the objective of this trial is to compare the effects of cognitive behavior and Solution-focused counseling on reduce blues and depression after childbirth. Design: a single blind, randomized clinical trial. Setting and conduct:In this study, nullipar pregnant women at 30-35 weeks'of pregnancy after obtaining informed consent, based on blocks with size of six were randomly divided into 3 groups, cognitive behavioral and solution-focused counseling and a control group. Inclusion criteria: nullipar pregnant women and at least a primary education, history of mental illness in the past, and lack of antenatal classes. Exclusion criteria: Mental illnesses, including schizophrenia, depression, anxiety in the past, and this pregnancy. Intervention:during three sessions of cognitive behavioral counseling and oriented solutions counseling during the two weeks of pregnancy is 30-35 weeks and the control group use regular prenatal care and then on 5 and 15 postpartum Stein and Edinburgh questionnaire to be completed and then mean blues and depression can be compared with each other
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052522407N1
Registration date:2015-08-15, 1394/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Somayeh Ramezani
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7213
Email address
s.ramezani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral counseling and Solution-focused counseling on postpartum blues and depression compared with routine pregnancy care
Public title
The effect of cognitive behavioral counseling and Solution-focused counseling on postpartum blues and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: nullipar pregnant women; women at least with a primary education; no participating in prenatal care education classes.
Exclusion criteria: mental illnesses; including schizophrenia; depression or anxiety in the past and during the current pregnancy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2015-07-15, 1394/04/24
Ethics committee reference number
IR.shmu.rec.1394.67
Health conditions studied
1
Description of health condition studied
Pregnant women
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Postpartum blues
Timepoint
Prior to intervention and five and fifteen days after childbirth
Method of measurement
Stien standard questionnaire
2
Description
Depression
Timepoint
Prior to intervention and five and fifteen days after childbirth
Method of measurement
Edinburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:cognitive-behavioral counseling in three sessions of two hours
Category
Prevention
2
Description
Intervention group: Solution-focused counseling in two sessions of two hours
Category
Prevention
3
Description
Control group: routine care during pregnancy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Azima health center
Full name of responsible person
Somayeh Ramezani
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square,shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud university of medical sciences ,Hafte Tir Square, Shahroud .
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Somayeh Ramezani
Position
MAster science of student counseling midwifery
Other areas of specialty/work
Street address
Central building ofShahroud university of medical sciences, Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 4499
Fax
Email
S.ramezani82@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Ahmad Khosravi
Position
Faculty member
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
Email
a.khosravi@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Somayeh Ramezani
Position
Master science ofstudent counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud university of medical sciences, Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 7213
Fax
+98 23 3239 4800
Email
S.ramezani82@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)