Comparison of effectiveness of Cognitive-behavioral Therapy (CBT) and Attentional Bias Modification (ABM) on the Anxiety of the Pregnant Women
Design
A clinical trial with a control group, with parallel groups, multi-stage random, with 72 participants in the study, was followed from July 1 to December 2016 for six months.
Settings and conduct
This study was performed on 72 pregnant nulliparous women referring to health centers in Kerman. from the four regions of Kerman city, region three was selected by random and then among the health centers of this area, three main clinics were selected randomly. Samples were assigned random to each of three groups including CBT, ABM and control. in each of these clinics, demographic questionnaire and Spielberger anxiety questionnaires were completed by pregnant women who were referred to these clinics. The sample size was obtained by convenient sampling at this stage. The eligible participants entered in the study after obtaining informed consent. CBT group was exposed to six two-hour sessions per week. The ABM group received intervention using the modified dot-probe task at six sessions, one session per week and the control group did not receive any intervention. To collect the data, the questionnaires were completed three times: before the intervention, immediately after the intervention and one month after intervention. Data were analyzed using SPSS version 22 and descriptive and Inferential Statistical Indices.
Participants/Inclusion and exclusion criteria
age between 18-35 years؛ primigravid؛ gestational age 14-28 weeks؛ low-risk pregnancy؛ desired pregnancy؛ low to moderate anxiety scores؛ having at least a middle school education؛ willing to attend the educational sessions and ability of doing homework
Intervention groups
CBT Group
ABM group
Control group
Main outcome variables
Reducing Anxiety in Pregnant Women
General information
Reason for update
Acronym
CBT, ABM
IRCT registration information
IRCT registration number:IRCT20180922041082N1
Registration date:2019-01-20, 1397/10/30
Registration timing:retrospective
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Masoud Fazilat-Pour
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 34 3613 4670
Email address
fazilatm@uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
2016-06-21, 1395/04/01
Actual recruitment end date
2016-07-22, 1395/05/01
Trial completion date
2016-12-20, 1395/09/30
Scientific title
Effectiveness of CBT and Attentional Bias Modification on the Anxiety of the Pregnant Women: A Comparative Study
Public title
Effectiveness of CBT and Attentional Bias Modification on the Anxiety of the Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-35 years
primigravid
gestational age 14-28 weeks
low-risk pregnancy
desired pregnancy
low to moderate anxiety scores
having at least a middle school education
willing to attend the educational sessions
ability of doing homework
Exclusion criteria:
pregnancy complications such as bleeding, diabetes, hypertension, preterm delivery and internal illness
use of anxiolytics and anti-depressants
having encountered with severe stress during the intervention period e.g., the death of first-degree relatives, divorce, spouse in prison.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Multi stage randomization: In order to facilitate the access to sampling units and from the four regions of Kerman city, region three was selected by random sampling. Then, three main clinics were selected randomly among health centers of this area. These three centers were also assigned as two intervention groups and one center as control group. Afterwards, based on the inclusion and exclusion criteria of the study and after obtaining informed consent, eligible participants were entered the study. It should be noted that in all cases of randomization, the lottery method was employed.
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 Kerman University of Medical Sciences
Street address
Medical University Campus, Haft-Bagh Highway, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.Kmu.REC.1395.93
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety levels in pregnant women
Timepoint
Measure anxiety level before intervention, immediately after intervention, one month after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Cognitive Behavioral Therapy (six two-hour sessions per week)
Category
Behavior
2
Description
Second intervention group: Attentional Bias Modification (using the modified dot-probe task at six sessions, one session per week, first and sixth sessions for half an hour, and the remaining sessions in about 10 minutes)
Category
Behavior
3
Description
Control group: No intervention received.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghodrat Health Center
Full name of responsible person
Nadia Nisi
Street address
Shaykh Ahmad Kafi North Street
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3321 0030
Email
sit@kmu.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Resalat Health Center
Full name of responsible person
Zohre Rezaei
Street address
South Abuzar, Alley 10
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3321 4609
Fax
Email
sit@kmu.ac.ir
3
Recruitment center
Name of recruitment center
Goldasht Health Center
Full name of responsible person
Setare Nozhati
Street address
Alley No. 64, Mizra Aga Khan Street
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3324 3475
Email
sit@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Medical University Campus, Haft-Bagh Highway, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
sit@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?