Evaluation of effectiveness of attention rehabilitation on clinical symptoms and cognitive impairment in patient with obsessive compulsive disorder
Design
Randomized clinical trial with control group
Settings and conduct
At first, patients with obsessive-compulsive disorder are divided into intervention and control groups randomly. All persons participated in the pre-test and then the intervention group participated in eight sessions of two-hour intervention according to the proposed protocol, then both groups will perform the post-tests and after a one-month follow-up, a cognitive assessment and evaluation of clinical symptoms will be performed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-40 years old; the education at least six classes; the desire to participate in the study; new diagnosis of obsession; non attending in non-drug treatment sessions simultaneously.
Exclusion criteria: existence simultaneous addiction; existence simultaneous disabling psychiatric disease؛; existence simultaneous neurological disease
Intervention groups
Participants in the intervention group are the patients with obsessive-compulsive disorder rehabilitation session are held at eight session for them. The control group consist of patients with obsessive-compulsive disorder that received only relaxation.
Main outcome variables
Obsession and cognitive impairment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131130015589N3
Registration date:2019-09-23, 1398/07/01
Registration timing:registered_while_recruiting
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Arash Mani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 3070
Email address
mania@sums.ac.ir
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
Effectiveness of attention cognitive rehabilitation on clinical and cognitive symptoms of obsession-compulsion disorder; A randomized clinical trial
Public title
Effectiveness of attention cognitive rehabilitation on clinical and cognitive symptoms of obsession-compulsion disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-45
The education at least six classes
The desire to participate in the study
New diagnosis of obsession
Non attending in non-drug treatment sessions simultaneously
Exclusion criteria:
Existence simultaneous addiction
Existence simultaneous disabling psychiatric disease
Existence simultaneous neurological disease
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation table
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants were kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical sciences
Street address
Central building of shiraz university of medical sciences, Zand Avenue, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-02-13, 1397/11/24
Ethics committee reference number
IR.SUMS.MED.REC.1397.415
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
Measure of obsession
Timepoint
Before study, exactly after intervention and one month after intervention
Method of measurement
Yale brown obsessive compulsive test
2
Description
Cognitive impairment
Timepoint
Before study, exactly after intervention and one month after intervention
Method of measurement
Auditory verbal learning test,rey osterrieth complex figure test,symbol digit modality task ,letter number sequencing,backward digit spam task,forward digit spam task,letter digit modality task,trail making test A and B,verbal fluency,stroop test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the patients with obsessive-compulsive disorder rehabilitation session are held at eight session for them. Subjects of sessions:1) pre-test and introduce attention, 2) introduce cognitive impairment in obsessive-compulsive disorder, 3) intervention training at the first level of attention, 4) intervention training at level of continuous attention, 5) intervention training at level of divided attention, 6) integration of techniques, 7) practice, 8) practice and complete post-test
Category
Treatment - Other
2
Description
Control group: patients with obsessive-compulsive disorder that received only relaxation training.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza clinic
Full name of responsible person
Anahita Amini
Street address
Namazi sq.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Fax
Email
emamreza@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hafez hospitol
Full name of responsible person
Anahita Amini
Street address
Chamran blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
3
Recruitment center
Name of recruitment center
Ebne sina hospital
Full name of responsible person
Anahita Amini
Street address
Hafez Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3228 9600
Email
Sinahosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yunes Ghasemi
Street address
Central building of Shiraz University of Medical Sciences, Zand Avenue., Shiraz city
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Anahita Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Central building of shiraz university of medical sciences, Zand Avenue, Shiraz city
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 713230541019
Email
Aminianahita27@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Anahita Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrist
Street address
Central building of shiraz university of medical sciences, Zand Avenue, Shiraz city
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 713230541019
Email
Aminianahita27@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Anahita Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Central building of shiraz university of medical sciences, Zand Avenue, Shiraz city
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 713230541019
Email
Aminianahita27@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data about the obsession
When the data will become available and for how long
6 momths after publishing results
To whom data/document is available
The Researchers working in academic and sciences center
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Aminianahita27@gmail.com
What processes are involved for a request to access data/document