Comparison of the effects of cognitive behavioral therapy and pharmacotherapy on infertility Background: Infertility has been described as creating a form of stress that can give increase to a variety of psychological problems. Both psychotherapy and pharmacotherapy are effective treatments for infertility stress. The aim of this study was to compare the effectiveness of cognitive behavioral therapy with fluoxetine in the decreasing of infertility stress in infertile women. Materials and Methods: In a randomized controlled clinical trial, 89 infertile women with mild to moderate depression (Beck scores 10–47) were recruited into three groups; cognitive behavior therapy (CBT), antidepressant therapy, and a control group. Twenty-nine participants in the CBT method received gradual relaxation training, restructuring, and eliminating of negative automatic thoughts and dysfunctional attitudes to infertility for 10 sessions. Thirty participants in the pharmacotherapy group took 20 mg fluoxetine daily for 90 days. Thirty control subjects did not receive any intervention. All participants completed fertility problem inventory (FPI) and the Beck Depression Inventory (BDI) at the beginning and end of the study. X 2 test, paired t-test, ANOVA and Tukey test were used to analyze the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061710048N1
Registration date:2012-06-20, 1391/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-20, 1391/03/31
Registrant information
Name
Hajar Pasha
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9592
Email address
h.pasha@mubabol.ic.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Science
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2007-12-21, 1386/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of cognitive behavioral therapy and pharmacotherapy on infertility stress: A randomized controlled trial
Public title
Comparison of the effects of cognitive behavioral therapy and pharmacotherapy on infertility stress
Purpose
Supportive
Inclusion/Exclusion criteria
Women with these characteristics were invited to this study: age younger than 45 years old; education more than five years; infertility more than two years, having at least one IVF; not undergoing fertility treatment until 3 months afterward; not currently practicing any relaxation techniques; not participating in any support group; not currently taking any psychotherapy; not currently undergoing any assisted reproductive therapy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
89
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
Babol University of Medical Sciences Ethics Committee
Street address
Babol University of Medical Sciences
City
Babol
Postal code
-
Approval date
2007-02-24, 1385/12/05
Ethics committee reference number
6133/30
Health conditions studied
1
Description of health condition studied
Infertility stress
ICD-10 code
F40-48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Evaluation of fertility problem in infertile women(fertility stress Inventory), depression before intervention
Participants in the CBT group were engaged in a 10-week, two-hour group cognitive behavior therapy program. Progressive muscle relaxation was added to sessions 5–10. Groups consisted of 8–12 members and the therapist was an expert psychologist who trained for the CBT program. Therapy was conducted at the Psychiatry Department of the Babol University of Medical Sciences. The first three sessions provided patients with a general orientation to cognitive therapy and the causes of infertility. A gynecologist participated in the first three sessions for 30 minutes and explained the cause of infertility for each patient.Cognitive interventions have been based on the premise that both negative automatic thoughts and dysfunctional attitudes to social concerns, sexual concerns, marital concerns, rejection of childfree lifestyle, and need for parenthood more require restructure. The following three sessions (sessions 4–6) included the identification and challenging of core dysfunctional or irrational beliefs that underlie automatic negative thoughts about the infertility. Finally, sessions 7–10 taught participants varying techniques (e.g. countering, self-reward) for maintaining the change of their dysfunctional beliefs about infertility. In addition to the above program, sessions 5–10 taught participants progressive muscle relaxation in a group setting. For home practicing, subjects read a relaxation book and listened to a 20-minute pre-recorded CD two times daily over a period of 5 weeks. Cognitive sessions were conducted based on Beck Depression Inventory and tension releasing sessions were conducted based on Relaxation Inventory of Jacobson.
Category
Behavior
2
Description
The pharmacotherapy group took a capsule of fluoxetine (20 mg) daily for 90 days. After the interview, the subjects took 30 capsules from the midwives of the center and return monthly to get their drug
Category
Treatment - Drugs
3
Description
The control group didn’t undergo any drug or psychological intervention. They completed two questionnaires at the beginning of the study and 3 months after the interview
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Alzahra fertility &i nfertility Health Research Center, Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Street address
Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mostafazadeh
Street address
Babol University of Medical Sciences
City
Babol
Grant name
مورخ 19/10/1385
Grant code / Reference number
201191025
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Psychologist, PhD
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1329 4456
Fax
+98 11 1219 9936
Email
mahbob330@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Position
Msc
Other areas of specialty/work
Street address
در قسمت اسپانسر نام خود را مرقوم نفرمایید. لطفا نام و مشخصات و آدرس و تلفن معاون پژوهشی موسسه ای که بودجه تحقیق را فراهم کرده یا دانشگاهی که تحقیق در آن اتفاق افتاده است را وارد کنید.
City
babol
Postal code
Phone
+98 12 1327 0576
Fax
+98 11 1219 9936
Email
h.pasha@mubabol.ic.ir; hajarpasha@yahoo.com
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
Psychologist, PhD
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1329 4456
Fax
+98 11 1219 9936
Email
mahbob330@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)