The aim of this study was to compare the effects of pharmacotherapy and Cognitive Behavior Therapy (CBT) on sexual function of females with Obsessive Compulsive Disorder (OCD).
Inclusion criteria: 18-52 years old married female patients who were diagnosed with OCD based on DSM- IV-TR.
Exclusion criteria: comorbid axis I and axis II disorders according to clinical interview, past history of sexual dysfunction before the recent episode and other diseases or factors effecting on sexual function except OCD.
A total of 58 patients were selected and with permuted block randomization divided into two groups of twenty nine patients for CBT and pharmacotherapy. This study was a single blind clinical trial and blinding was done for the patients. The patients of pharmacotherapy group received 60 mg of capsule Fluoxetine twice a day, whereas the patients of CBT group had ten CBT sessions of forty five minutes long per week done by a clinical psychologist. The obsessions and compulsions and their severity, sexual function, marital satisfaction and sexual satisfaction of patients were assessed both before the interventions and three months after drug intervention and after ten sessions of CBT using the Obsessive Compulsive Yale Brown Scale, Female Sexual Function Index, Marital Satisfaction Scale of Enrich and Sexual Satisfaction Scale, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091014619N1
Registration date:2015-05-19, 1394/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Zahra Sabetnejad
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 9111
Email address
zsabetnejad@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2014-06-10, 1393/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pharmacotherapy with Fluoxetine and Cognitive- Behavior Therapy on sexual function of females with Obsessive-Compulsive Disorder
Public title
The effect of Fluoxetine and Cognitive- Behavior Therapy on sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-52 years old married female patients with Obsessive-Compulsive Disorder according to DSM IV-TR criteria
Exclusion criteria: Comorbid axis I and axis II disorders according to clinical interview; psychotic symptoms; past history of sexual dysfunction before recent episode; endocrine disorders (thyroid dysfunction and Diabetes Mellitus); local genitalia problems (vaginitis, pelvic infections); hypogonadism; cardiovascular disorders (angina, Myocardial Infarction); renal dysfunction; neurologic disorders (Cerebrovascular accident, spinal injuries, autonomic pelvic neuropathy); history of abdominal and pelvic surgeries causing sexual dysfunction (oophorectomy, surgery for prolaps); psychiatric drug reception during last month; using other drug causing sexual dysfunction
Age
From 18 years old to 52 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The blinding is for the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th kilometer of Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Approval date
2013-08-22, 1392/05/31
Ethics committee reference number
2049/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Sexual dysfunction, Obsessive- compulsive disorder
ICD-10 code
F52, F42
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease, Obsessive-compulsive disorder
Primary outcomes
1
Description
Kind and severity of obsessions and compulsions
Timepoint
Before the onset of intervention, three months after the onset of intervention
Method of measurement
Obsessive- Compulsive Yale Brown Scale
Secondary outcomes
1
Description
Sexual function
Timepoint
Before the onset of intervention,three months after the onset of intervention
Method of measurement
Female Sexual Function Index
2
Description
Sexual satisfaction
Timepoint
Before the onset of intervention, three months after the onset of intervention
Method of measurement
Sexual Satisfaction Scale
3
Description
Marital satisfaction
Timepoint
Before the onset of intervention,three months after the onset of intervention
Method of measurement
Marital Satisfaction of Enrich Scale
Intervention groups
1
Description
Drug intervention: 60 mg capsule Fluoxetine daily (twice daily) for 3 months.
Category
Treatment - Drugs
2
Description
Nondrug intervention group: Cognitive- Behavior Therapy done by clinical psychologist during 10 forty five minutes sessions weekly.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Karegarnejad Psychiatric Hospital
Full name of responsible person
Dr. Fatemeh Assarian.The specialty of Psychiatrist Children and Adolescent
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Blvd.
City
kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Assarian
Position
The specialty of Psychiatrist Children and Adolescent
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+31 55549111
Fax
Email
fa_assar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Assarian
Position
The specialty of Psychiatrist Children and Adolescent
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravand Blvd.
City
Kashan
Postal code
Phone
+31 55549111
Fax
Email
fa_assar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Sabetnejad
Position
Psychiatric Resident
Other areas of specialty/work
Street address
City
Kashan
Postal code
Phone
00
Fax
Email
zsabet2020@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)