Protocol summary

Summary
Because of stresses and demands of new roles and parental responsibilities, These can be a considerable resource of anxiety and depression to new parents. Thus, aim of this study is to decreasing of depression and increasing of marital satisfaction in pregnant women. In order to these purposes, two approaches are used: cognitive-behavioral therapy (CBT) and Interpersonal Psychotherapy (IPT). Participants included in first, second and third trimester of pregnancy period. Statistical sample composed of 36 pregnant women that have been tested by tools of research: Beck Depression Inventory (BDI), Marital satisfaction Inventory (ENRICH). Design of research is pretest- posttest with group control. Expected results are: decreasing of depression and increasing of marital satisfaction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305195181N9
Registration date: 2013-08-11, 1392/05/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research ,Tehran University of Medical sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT) on reducing depression during pregnancy and increasing marital satisfaction
Public title
Comparison of efficacy of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT) on reduction of depression and marital satisfaction during pregnancy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: All of pregnant women included in first, second and third trimesters. Exclusion: All of pregnant women that have used anti- depression drugs lately.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
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
vice Chancellor for Research ,Tehran University of Medical Science.
Street address
Bulding of Vice Chancellor for Research, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-05-04, 1392/02/14
Ethics committee reference number
21897

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
f32.8
ICD-10 code description
Other depressive episodes

Primary outcomes

1

Description
Depression
Timepoint
Before the intervention an 3 month after the intervention in both group (CBT, IPT)
Method of measurement
Questionaire(BDI and ENRICH)

Secondary outcomes

1

Description
Marital satisfaction
Timepoint
Before the intervention an 3 month after the intervention in both group (CBT, IPT)
Method of measurement
Questionaire( BDI and ENRICH)

Intervention groups

1

Description
In first group:intervention based on personal behaviors and cognition counseling for two hours 8 session
Category
Lifestyle

2

Description
In second group:intervention based oninter personal relationship counseling for two hours 8 session
Category
Lifestyle

3

Description
In third group or control group , intervention is not used.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-asr Reproductive Health Research Center
Full name of responsible person
َAli GHaredaghi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research,Tehran University of Medical Sciences
Full name of responsible person
mostofi
Street address
Bulding of Vice Chancellor for Research, Ghods St., Keshavarz Blvd.
City
Tehran
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,Tehran 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
Vali-e-Asr reproductive HealthnResearch center
Full name of responsible person
Ali Gharedaghi
Position
PHD
Other areas of specialty/work
Street address
Milan 11,Kavoosi Street,Heidari jonobi S,Shahrake Valieasr,Tehran.
City
Tehran
Postal code
Phone
+98 21 6624 7120
Fax
Email
dr.gharadaghi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-asr Reoroductive Health Research Center
Full name of responsible person
Ali Gharedaghi
Position
PHD
Other areas of specialty/work
Street address
Milan 11,Kavoosi Street,Heidari jonobi S,Shahrake Valieasr,Tehran
City
Tehran
Postal code
Phone
+98 21 6624 7120
Fax
Email
dr.gharadaghi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Haghollahi Fedyeh
Position
Research expert
Other areas of specialty/work
Street address
Imam Khomeini hospital,Vali-e-asr hospital
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
fedyeh_hagh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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