The efficacy of cognitive behavioral therapy with and without Sertraline in patients with obsessive-compulsive disorder
Design
Clinical trail with two arm parallel groups without control group, without randomization and blindness with sample size of 20 for each group and the whole sample size of 40
Settings and conduct
Participants were recruited through self referrals, professional and clinic referrals, and advertisements in hospital and networks. Patients were divided into two groups , CBT with and without Sertraline. Study duration is 12 weeks in all groups. In the CBT group the sessions would be twice a week during the first month and the duration of every session is 2 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of disorder; age between 18 to 65 ; education at least grade 7
Yale brown obsessive compulsive scale total scores equal and more than 16
Exclusion criteria;History or current bipolar disorder and psychotic disorders; current major depressive episode and suicidal ideation ; substance or alcohol dependency in the 6 past months.
Intervention groups
This study consists of two interventional groups. One is cognitive behavior therapy and the other is cognitive behavior therapy plus Sertraline. the duration of the study is twelve weeks.psychotherapy is going to be once a week and sertraline initiates by 25 milligram up to 200 milligram as needed. the study dose not have any control group.
Main outcome variables
Severity of obsessive compulsive disorder measured by Yale Brown Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046273N1
Registration date:2020-05-02, 1399/02/13
Registration timing:registered_while_recruiting
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
marzieh effatpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3271 3571
Email address
hosseiniyamin88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive behavioral therapy with and without Sertraline in patients with obsessive compulsive disorder
Public title
The efficacy of cognitive behavioral therapy with and without Sertraline in patients with obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of disorder
age beween 18 to 65
education at least grade 7
yale brown obsessive compulsives scale total score>= 16
Exclusion criteria:
History or current bipolar disorder
History psychotic disorders
Current major depressive episode and suicidal ideation
Substance or alcohol dependency in 6 past months.
History of adequate treatment with sertraline (200 mg in 8 weeks)
History of adequate treatment with CBT( more than 3 sessions in week during more than 2 weeks )
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of ebne sina University of Medical Sciences
Intervention group 1 is cognitive behavior therapy. Cognitive behavioral sessions are once a week for a while of one hour in Sina Hospital in Hamedan City. the duration of the study is twelve weeks. During the study patients will be assessed by yale Brown scale three times in the baseline, the mid treatment and after treatment.
Category
Treatment - Other
2
Description
Intervention group 2 is cognitive behavioral therapy plus sertraline. Cognitive behavioral therapy in this group is exactly the same as intervention group 1.In addition Sertraline will be administrated by 25 mg daily and according to each patients need gradually get to 200 mg daily in the first 4 weeks. the duration of the study is twelve weeks.During the study patients will be assessed by yale Brown scale three times in the baseline, the mid treatment and after treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital and Social networks
Full name of responsible person
Marzieh Effat Panah
Street address
No. 16, Balal Ave.,Jafar Tayar Blvd.
City
Hamedan
Province
Hamadan
Postal code
6514757694
Phone
+98 81 3271 3571
Email
hoseiniyamin88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Medical University of Hamedan .Ahmadi Roshan Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Marzieh Effat Panah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 16, Balal Ave., Jafar Tayar Blvd.,
City
Hamedan
Province
Hamadan
Postal code
6514757694
Phone
+98 81 3271 3571
Email
hosseiniyamin88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Latif Moradveisi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Farshchian Hospital. Honarestan Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3827 4184
Email
latif.moradveisi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Marzieh Effat Panah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 16, Balal Ave.,Jafar Tayar Blvd.,
City
Hamedan
Province
Hamadan
Postal code
6514757694
Phone
+98 81 3271 3571
Email
hosseiniyamin88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available