Protocol summary

Summary
The purpose of this study was to investigate the effects of educational -cognitive-behavioral therapy for the prevention and reduction of postpartum depression. 135 at risk mothers from two hospitals in Tehran were participated in the research. Participants who meet inclusion criteria including aged 18 -32 years, had a single birth and an uncomplicated pregnancy completed the pretests comprised of Beck Depression and Anxiety Questionnaires as well as Edinburgh Postnatal Depression Scale. Those who use antidepressant/anti-anxiety medications were excluded. Following completion of the pretests participants were randomly assigned to the CBT intervention and control condition. In this study, intervention was introduced in the third trimester of pregnancy and post test was conducted 2 weeks after delivery. The intervention group received 8 session of educational- cognitive behavioral program completed weekly, which composed of two parts including component imparting information about the realities of parenthood and normal infant development problems and cognitive behavioral therapy, focusing on improving depressing mood and negative thinking and problem solving skills.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014040617134N1
Registration date: 2014-05-20, 1393/02/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Ahmad Ahmadi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8209 5075
Email address
ahmady457@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center
Expected recruitment start date
2012-08-26, 1391/06/05
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of educational -cognitive-behavioral therapy for the prevention and reduction of postpartum depression
Public title
Prevention and reduction of postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: participants aged 18-32 years; had a single birth; an uncomplicated pregnancy Exclusion criteria: using Antidepressant/Anti-anxiety medications
Age
From 18 years old to 32 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 135
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
Ethics committeeof Baghiatallah University of Medical Sciences
Street address
Tehran,
City
Baghiatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran, Iran
Postal code
Approval date
2012-04-24, 1391/02/05
Ethics committee reference number
س/22/340

Health conditions studied

1

Description of health condition studied
postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

Primary outcomes

1

Description
Depression
Timepoint
pretest Before introducing the intervention and before delivery, posttest after delivery
Method of measurement
Beck Depression Inventory, Beck Anxiety Inventory, Edinburgh Postnatal Depression Scale

Secondary outcomes

1

Description
Anxiety
Timepoint
preters Before Delivery, post testafter Delivery
Method of measurement
Beck Anxiety Inventory

Intervention groups

1

Description
The intervention group received 8 session of educational- cognitive behavioral program 40 to 60 minutes per sessions which composed of two parts including component a) imparting information about the realities of parenthood and normal infant development problems and b) cognitive behavioral therapy, focusing on improving depressing mood and negative thinking and problem solving skill. The intervention was designed and delivered by a multidisciplinary team. The intervention takes place in the hospital along with educational guide booklet and films.
Category
Behavior

2

Description
Participants in the control group will continue to be under the normal care of their midwife/GP and received usual antenatal education. There were no restrictions on the treatment that they can receive.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghiatollah Hospital
Full name of responsible person
Ahmad Ahmadi
Street address
Baghiatollah Hospital, Molasadra Street, Vanak Square,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Ali Fathi-Ashtiani
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaei Street, Molasadra Street, Vanak Square, Tehran
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 of Baqiyatallah 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
University of Tehran
Full name of responsible person
Ahmad Ahmadi
Position
PhD student
Other areas of specialty/work
Street address
Faculty of Psychology & Education of University of Tehran, Kardan street, Jalal Ale Ahmad Street, Chamran Expressway, Tehran
City
Tehran
Postal code
1445983861
Phone
+98 21 8209 5075
Fax
Email
Ahmady457@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Ahmad Ahmadi
Position
PhD Student
Other areas of specialty/work
Street address
Faculty of Psychology & Education of University of Tehran, Kardan street, Jalal Ale Ahmad Street, Chamran Expressway, Tehran
City
Tehtan
Postal code
Phone
+98 21 8209 5075
Fax
Email
ahmady457@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Ahmad Ahmadi
Position
PhD student
Other areas of specialty/work
Street address
Faculty of Psychology & Education of University of Tehran, Kardan street, Jalal Ale Ahmad Street, Chamran Expressway, Tehran
City
Tehran
Postal code
Phone
+98 21 8209 5075
Fax
Email
ahmady457@gmail.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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