Comparative effectiveness of combination of exposure and response prevention (ERP) and pharmacotherapy versus transcranial direct current stimulation (tDCS) and pharmacotherapy in treatment of anxiety, depression, quality of life and obsessive compulsive symptoms in patients with obsessive-compulsive disorder.
The aim of this study was to compare the efficacy of two therapies in combination with medications for obsessive-compulsive disorder. For this reason 15 patients will be selected from who visit the Beheshti hospital of Zanjan and will divided in 2 groups randomly. The most important inclusion criteria is signing a written consent and lack of psychological treatments and supplements for at least one month before the study. The most important exclusion criteria is risks like suicidal/homicidal thoughts.This study is therapeutic intervention without placebo, not blind test. In the first session all patients will complete questionnaires for depression, anxiety, quality of life and signs of obsession and compulsion. These questionnaires will be completed again at the end of treatment. ERP treatment based on protocol of approximately 8-12 sessions and tDCS based on protocol of 10 sessions. The consequence of this trial will be use to compare the effectiveness of ERP and tDCS treatment in symptoms of depression, anxiety, quality of life and obsessive compulsive symptoms in patients with obsessive compulsive disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061728504N1
Registration date:2016-07-26, 1395/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-26, 1395/05/05
Registrant information
Name
Vida Yousefi Asl
Name of organization / entity
Zanjan University of Mrdical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 4766
Email address
vida.yousefi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of combination of exposure and response prevention (ERP) and pharmacotherapy versus transcranial direct current stimulation (tDCS) and pharmacotherapy in treatment of anxiety, depression, quality of life and obsessive compulsive symptoms in patients with obsessive-compulsive disorder.
Public title
Exposure and response prevention (ERP) versus transcranial direct current stimulation (tDCS) in treatment of patients with obsessive-compulsive disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Full diagnostic criteria of obsessive compulsive disorder; having a minimum grade education; the age range between 18-50 years; signing a written consent; lack of psychological treatments and supplements for at least one month before the study. Exclusion criteria: Risks like suicidal/homicidal thoughts; full criteria of personality disorders; full criteria of psychosis or psychotic disorders.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi BLVD, Zanjan, Iran
City
Zanjan
Postal code
4515613191
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
ZUMS.REC.1394.336
Health conditions studied
1
Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive compulsive disorder
Timepoint
Pretest, Posttest, follow up after 1 month
Method of measurement
Yale-Brown obsessive compulsive scale
Secondary outcomes
1
Description
Depression
Timepoint
Pretest, Posttest, follow up after 1 month
Method of measurement
The Beck Depression Inventory
2
Description
Anxiety
Timepoint
Pretest, posttest, follow up after 1 month
Method of measurement
Beck anxiety inventory
3
Description
Quality of life
Timepoint
pretest, posttest, follow up after 1 month
Method of measurement
quality of life questionnaire
Intervention groups
1
Description
Exposure And Response Prevention (ERP)
Category
Treatment - Other
2
Description
transcranial direct current stimulation (tDCS)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Patients referred to the Beheshti clinic and Beheshti hospital.
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Soghrat Faghoh Zadeh
Street address
Zanjan University of Medical Sciences, Azadi BLVD, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
PhD in clinical psychology, Assistan professor of zanjan university of medical sciences
Other areas of specialty/work
Street address
Beheshti hospital, Sadi street, Zanjan, Iran
City
zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
mohsendadashi@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vida Yousefi Asl
Position
M.Sc. Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Behesti hospital, Sadi street, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
vida.yousefi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Vida Yousefi Asl
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
vida.yousefi@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)