Comparing the effectiveness of cognitive behavioral training and positive psychology training on psychological health in pregnant women with pregnancy anxiety
The aim of this research is comparing the effectiveness of cognitive behavioral training and positive psychology training on psychological health in pregnant women with pregnancy anxiety.
Design
Clinical trial with 2 experimental group (n=15) and one control group (n=15), parallel groups, randomized by random assignment in groups
Settings and conduct
The study will perform in 8 educational session to both experimental groups way in Ahar without blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria: 3-6 mounts pregnant; age 20-35; at least diploma
Exclusion criteria: having physical and psychological diseases in past
Intervention groups
Experimental group 1: 8 1-hour sessions of cognitive behavioral training for 1 month;
Experimental group 2: 8 1-hour sessions of positive psychology training for 1 month;
control group: without training
Main outcome variables
Pregnancy anxiety؛ anxiety sensitivity؛ resilience؛ quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171212037852N1
Registration date:2019-03-16, 1397/12/25
Registration timing:retrospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Mahdieh Jafari
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5000
Email address
m.jafari@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive behavioral training and positive psychology training on psychological health in pregnant women with pregnancy anxiety
Public title
The effectiveness of cognitive behavioral training and positive psychology training on psychological health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
3-6 mounts pregnant
at least diploma
age 20-35
Exclusion criteria:
Record of physical and psychological illnesses
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The member of sample assigned in the experimental and control group by lottery.
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 committee of Ardabil University of Medical Scienses
Street address
Daneshgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5451917961
Approval date
2017-10-04, 1396/07/12
Ethics committee reference number
IR.ARUMS.REC.1396.112
Health conditions studied
1
Description of health condition studied
Pregnancy Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy Anxiety
Timepoint
Before the training and 1 week after the training
Method of measurement
Prenatal Distress Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the training and 1 week after the training
Method of measurement
WHOQ-BREF
2
Description
Anxiety sensitivity
Timepoint
Before the training and 1 week after the training
Method of measurement
Anxiety sensitivity inventory
3
Description
Resistance
Timepoint
Before the training and 1 week after the training
Method of measurement
Resistance scale
Intervention groups
1
Description
Intervention group 1: 8 1-hour sessions of cognitive behavioral training for 1 month including: 1. introducing of participants, pre-test, explanation about nature of anxiety during pregnancy, 2. presentation of basic information about CBT, 3. The ways of realizing automatic thoughts, 4. evaluation of worries, 5. mindfulness training, 6. relaxation training, 7. the ways of problem solving, 8. review and post-test.
Category
Behavior
2
Description
Intervention group 2 : 8 1-hour sessions of positive psychology training for 1 month including: 1. introducing of participants, pre-test, explanation about nature of anxiety during pregnancy, 2. introduction of positive psychology, 3. recognizing strengths, 4. gratitude training, 5. satisfying versus maximizing training, 6. hope and optimism, 7. savoring, 8. review and post-test.
Category
Behavior
3
Description
Control group: without training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers in Ahar
Full name of responsible person
Mahdieh Jafari
Street address
Shahrdari Square
City
Ahar
Province
East Azarbaijan
Postal code
5451917961
Phone
+98 41 4433 3120
Email
m.jafari9372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mohaqeq Ardabili
Full name of responsible person
Mohammad Narimani
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, university street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5698725761
Phone
+98 45 3551 2081
Email
narimani@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mohaqeq Ardabili
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdieh Jafari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
m.jafari9372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdieh Jafari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
m.jafari9372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdieh Jafari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
m.jafari9372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available