A midwife will be invited to enter the study the women with recurrent abortion who have above 5 years education in Fatemeh Zahra Infertility and Reproductive Health research Center. Invited women fill Beck Depression Inventory and meet a psychologist. women with Beck Depression Inventory 10-30 who established the depression in clinical interview will suggested to enter the study. Severe depressed women excluded the stydy and reffer to a psychiatric. Eligible women will be enter the project with informed consent and fill Problem Infertility Inventory, Spielberger State- Traite Anxiety Inventory (STAI-Y), and Grief questionnaire (GQ). Patients with severe depression excluded the study and refferd to a psychiatric. 60 Eligible women assigned randomly to three equall groups 20 persons; psychotherapy, Pharmacotherapy and control.Psychotherapy group will give 10 session of Cognitive Analytic Group Therapy (1 hours weekly) for 10 weeks. Pharmacotherapy group take Serteralin pill with 100 miligram daily for 10 weeks. Control group did not give any interventions, but their pharmacotherapy or psychotherapy will be started immidiately at the end of study. All patients fiil 4 questionnairs ( BDI, FPI, STaI-Y, and GQ) at beginning, 10 weeks after the beginning, and 3 month-follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304045931N3
Registration date:2013-04-20, 1392/01/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of psychotherapy and pharmacotherapy on improvement of mental health of depressed women with recurrent spontaneous miscarriage
Public title
Comparison of psychotherapy and pharmacotherapy on improvement of mental health of depressed women with recurrent spontaneous miscarriage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of three or above spontaneous abortion, education above 5 years, depression mide to moderate.
Exclusion criteria: severe depression; attending in psychotherapy sessions and pregnancy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Babol University of Medical Sciences
Street address
Babol- Gang Afroz
City
Babol
Postal code
4715864247
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
2159
Health conditions studied
1
Description of health condition studied
Recurrent abortion
ICD-10 code
N96
ICD-10 code description
Habitual aborter
Primary outcomes
1
Description
Depression
Timepoint
Beginning of study , after 10 weeks, 3 month-follow up
Method of measurement
Beck Depression Inventory
2
Description
Anxiety
Timepoint
Beginning of study , after 10 weeks, 3 month-follow up
Method of measurement
Spieberger staite-trait Anxiety scale
3
Description
Fertility problem
Timepoint
Beginning of study , after 10 weeks, 3 month-follow up
Method of measurement
Fertility problem Inventory
4
Description
Grief
Timepoint
Beginning of study , after 10 weeks, 3 month-follow up
Method of measurement
Grief Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Psychotherapy group, will give 10 session of Cognitive Analytic Group Therapy (1 hours weekly) for 10 weeks.
Category
Treatment - Other
2
Description
Pharmacotherapy group, take Serteralin pill with 100 miligram daily for 10 weeks.
Category
Treatment - Drugs
3
Description
Control group did not give any interventions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Infertility and Reproductive Health research Center
Full name of responsible person
Dr.Seddigheh Smaelzadeh
Street address
Babol -Fatemeh Zahra Infertility and Reproductive Health research Center
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical
Full name of responsible person
Dr Mostafazadeh
Street address
Babol- Gang afroz street
City
Babol
Grant name
پژوهشی
Grant code / Reference number
2159
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical
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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistan professor
Other areas of specialty/work
Street address
Babol-Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@yahoo.com m.faramarzi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol-Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistant professor
Other areas of specialty/work
Street address
Babol-Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@yahoo.comm.faramarzi@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Assistant professor
Other areas of specialty/work
Street address
Babol- Babol University of Medical Sciences
City
Babol
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
mahbob330@ yahoo.com m.faramarzi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)