This study was aimed at determining the effectiveness of CBT on women’s anxiety with unintended pregnancy. The inclusion criteria were low-risk pregnancy, unintended pregnancy and the Beck`s anxiety score 14 to 30. The exclusion criteria were the lack of cooperation, abortion, referral or treatment for other problems which the research participants faced, and severe anxiety and depression. This study is a clinical trial consisting of 30 multiparous women. Multiparous women with low-risk pregnancies who were in the first half of pregnancy were randomly placed into two groups (case and control). Each group included 15 members. The case group underwent 8 cognitive-behavioral group therapy sessions, and the control group received routine pregnancy care. In this study, the intervention method used to control the anxiety of women in unintended pregnancy was a cognitive-behavioral therapy, which was held in eight 90-minute sessions. Each therapy session had a specific structure. One week after the last session of therapy, the Beck`s anxiety questionnaire was filled out by the female participants, and the results were compared with each other. The primary outcome of this study was reducing anxiety of unintended pregnancy among multiparous women in terms of the score obtained from the Bek anxiety questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120920252N1
Registration date:2016-11-18, 1395/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Omekolsum Tabarteh Farahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3373 0226
Email address
o.t.farahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavior therapy on women’s anxiety with unintended pregnancy
Public title
The effect of cognitive behavior therapy on women’s anxiety with unintended pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: fill out the form of informed consent; eighteen to forty years old; high school diploma; unintended pregnancy; multipariety; gestational age is lower than twenty weeks; low risk pregnancy and normal BMI; dont have severe depression and anxiety according to the Beck`s questionnaire; not using psychiatric drugs; anxiety score is 14 to 30 and dont havefamily conflicts. Exclusion criteria: willingness to participate in the other treatment and non- cooperation; continuous absence in cognitive behavioral therapy sessions; not fill out the follow-up questionnaire; severe pregnancy`s problems for mothers.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Basij Square, Arak, Markazi Province, Iran
City
arak
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.ARAKMU.REC.1394.50
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorders
Primary outcomes
1
Description
anxiety
Timepoint
Before intervention; one week after intervention
Method of measurement
Beck`s Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The control group receive routine antennal care
Category
N/A
2
Description
The intervention group attend eight cognitive-behavioral therapy sessions. The intervention method is cognitive behavioral group therapy. Eight group sessions is held during second trimester. Each ninety minutes session has a certain structure
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers Aristotle
Full name of responsible person
Naimeh Akbari Torkestani
Street address
Health centers Aristotle, 15 yards of Khatam, 30 yards of Emam Ali. Arak.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Arak University of Medical Sciences
Full name of responsible person
Naeimeh Akbari Torkestani
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
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 Arak 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
Arak University of Medical Sciences
Full name of responsible person
Naimeh Akbari Torkestani
Position
Senior in midwifery
Other areas of specialty/work
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
tnaimeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naimeh Akbari Torkestani
Position
Senior in midwifery
Other areas of specialty/work
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
tnaimeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Omm Kolsum Tabarteh Farahani
Position
Senior student of consultation in midwifery
Other areas of specialty/work
Street address
Sardasht Avenue, Basij Square, Arak, Markazi
City
Arak
Postal code
Phone
+98 86 3373 0226
Fax
+98 86 3417 3524
Email
farahani.k91@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)