Comparing the effect of two Methods of Couple-Oriented Group Counseling and Client-Oriented Counseling Using the Cognitive Behavioral Approach during pregnancy, on Anxiety, Stress, and Depression in postpartum period
This study is Intervention – experimental type (Rct). The aim of study will compared the Effectiveness of Two Methods of Couple-Oriented Group Counseling and Client-Oriented Counseling Using the Cognitive Behavioral Approach during pregnancy, on Anxiety, Stress, and Depression in postpartum period. The study population includes all pregnant woman who refers to Child Birth preparation center; of these, 78 samples with informed consent will be selected. According to inclusion (for women: age between20-40; gestational age 28-32 week- for men: ninth grate education; drug addiction) and exclusion criteria (mood disorders; a history of infertility; history of use psychiatric drugs) for samples, qualified samples were randomly divided into three groups (control, client oriented, couple oriented). Counseling classes during pregnancy will be conducted for 8 sessions, once a week.In this research depression anxiety stress score and will be used for data gathering. After data gathering, data will be analyzed. It is expected average score (anxiety, stress and depression) is dropped; immediately after the end of sessions and postpartum period.
General information
Acronym
cbct.cbgt
IRCT registration information
IRCT registration number:IRCT2016081029293N1
Registration date:2016-10-30, 1395/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Tayyebeh Shojaaddini Ardakani
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences. Nursing And Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 35 3224 4305
Email address
maryam_dafei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
ShahidSadoughi University Of Medical Science.
Expected recruitment start date
2016-07-07, 1395/04/17
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two Methods of Couple-Oriented Group Counseling and Client-Oriented Counseling Using the Cognitive Behavioral Approach during pregnancy, on Anxiety, Stress, and Depression in postpartum period
Public title
Effect of Counseling Using the Cognitive Behavioral Approach on Anxiety, Stress, and Depression in postpartum period
Purpose
Prevention
Inclusion/Exclusion criteria
Woman inclusion criteria:
Age between 20-40; Ability to speak and understand the language of Persian; ninth grate education; gestational age between 28-32 week.
Man inclusion criteria:ninth grate education.
Woman exclusion criteria: Complications during pregnancy; a history of serious psychiatric disorders such as: mood disorders, psychosis and anxiety, major depression and bipolar disorder; a history of infertility; use of assisted reproductive technology; history of use psychiatric drugs; History of participation in cognitive-behavioral counseling sessions relating to the treatment of depression; stress score greater than 33, anxiety score greater than28 and depression scores more than 20; drug dependence; first-degree relatives died in the last three months (grief)
Man exclusion criteria: drug addiction; history or current mental illness; history of participation in counseling sessions of cognitive-behavioral treatment for depression
Age
From 20 years old to 40 years old
Gender
Both
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi university of medical science.
Street address
yazd. bahonar square.
City
yazd
Postal code
.
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
ir.ssu.rec.1395.57
Health conditions studied
1
Description of health condition studied
stress, anxiety and depression in postpartum period
ICD-10 code
F43, F41,
ICD-10 code description
Reaction to severe stress, and adjustment disorders, Other anxiety disorders, Depressive episode
Primary outcomes
1
Description
stress
Timepoint
pretest, post test, 14 day after delivery
Method of measurement
DEPRESSION, ANXIETY, STRESS SCORE
2
Description
anxiety
Timepoint
pretest, post test, 14 day after delivery
Method of measurement
DEPRESSION, ANXIETY, STRESS SCORE
3
Description
depression
Timepoint
pretest, post test, 14 day after delivery
Method of measurement
DEPRESSION, ANXIETY, STRESS SCORE
Secondary outcomes
1
Description
postpartum depression
Timepoint
14 day after delivery
Method of measurement
Dass21
Intervention groups
1
Description
couple oriented approach
Counseling for once a week for 8 sessions with Cognitive Behavioral Approach
Category
Behavior
2
Description
client oriented approach
Counseling for once a week for 8 sessions with Cognitive Behavioral Approach
Category
Behavior
3
Description
control group without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziae Hospitah
Full name of responsible person
Miss Poorhusseini
Street address
Yazd, Ardakan , Sadrabad Street
City
Ardakan
2
Recruitment center
Name of recruitment center
Behdasht And Darman
Full name of responsible person
Miss shojaaddini ardakani
Street address
Yazd, Ardakan , Emam Street
City
Ardakan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University Of Medical Science. Nursing And Midwifery College
Full name of responsible person
Research Accessorial Of Shahid Sadoughi University Of Medical Science. Nursing And Midwifery Colleg
Street address
Yazd. Bahonar squar
City
yazd
Grant name
27940000
Grant code / Reference number
4699
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University Of Medical Science. Nursing And Midwifery College
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
Shahid Sadoughi University Of Medical Science. Nursing And Midwifery College
Full name of responsible person
Tayyebeh Shojaaddini Ardakani
Position
Msc student
Other areas of specialty/work
Street address
Nursing and Midwifery college, Bu Ali Street, Yazd