Introduction: The aim of this study is to investigate the effect of group cognitive-behavioral therapy on antepartum depression.
Research method: The study population of this clinical trial included 12-22 weeks pregnant women who went to Qazvin health centers and were diagnosed with mild to moderate depression (based on the Beck Depression Inventory), for the first time. 60 individuals were selected using convenience sampling method and were randomly divided into two groups of 30 subjects, including the test and the control groups. Randomization was done through block randomization using blocks of random sizes. Subjects in the test group underwent 6 sessions of group cognitive-behavioral therapy on a weekly basis, based on the brief guide to depression intervention provided by Iranian Ministry of Health and Medical Education; and the control group received no training. Immediately after the end of the course and two months later, the Beck test was performed on all subjects, as a post-test.
Criteria for entering the study: 12 - 22 week pregnant women who were diagnosed with mild to moderate depression for the first time; middle school or higher education; Not being diagnosed with chronic and infectious diseases (diabetes, high blood pressure, etc.); Not having symptoms of pregnancy (bleeding, placenta previa, ...)
Conditions because of which one would have to leave the study: Use of psychiatric drugs; lack of interest in continuous participation in counseling sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042533518N3
Registration date:2017-10-17, 1396/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Zinat Jourabchi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 7268
Email address
zjourabchi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of group cognitive-behavioral counseling on pregnancy depression in pregnant women 12 - 22 weeks
Public title
Determining the effect of group cognitive-behavioral counseling on pregnancy depression in pregnant women 12 - 22 weeks
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for entering the study: 12 - 22 week pregnant women who were diagnosed with mild to moderate depression for the first time; middle school or higher education; Not being diagnosed with chronic and infectious diseases (diabetes, high blood pressure, etc.); Not having symptoms of pregnancy (bleeding, placenta previa, ...)
Conditions because of which one would have to leave the study: Use of psychiatric drugs; lack of interest in continuous participation in counselor sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done through block randomization using blocks of random sizes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
34197-59811
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.QUMS.REC.1395.196
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode - unspecified
Primary outcomes
1
Description
Depression during pregnancy
Timepoint
Immediately after the intervention and two months later
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The program of cognitive group therapy lasted 6 weeks. Each session lasted about an hour and in cases of delay in holding the discussion or the discussion taking too long, the duration of the meeting would increase. The interval between sessions was decided to be one day a week.The sessions plan included five areas: changing beliefs and sketchy processes, discovering a negative belief system, testing beliefs, changing beliefs and changing ineffective behavior.
Category
Behavior
2
Description
Control group: Did not receive any treatment.
For the control group, no particular plan was considered, but were controlled only by other intervention factors.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bolandian Health Center
Full name of responsible person
Atefe Safaralinezhad
Street address
Shahid Bolandian Health Center, Shahid babai st, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr.Zihinat jourabchi
Street address
Qazvin University of Medical Sciences, bahonar blv, Qazvin
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Jourabchi
Position
PhD in Community Health, Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
zinat.jourabchi@ymail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Jourabchi
Position
PhD in Community Health, Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Fax
+98 28 3323 7268
Email
zinat.jourabchi@ymail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Atefe Safaralinezhad
Position
MSc Student in Counseling in midwifery
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
34197-59811
Phone
+98 283352982
Fax
-
Email
atefealinezhad@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)