A study of effect of self-regulation training on reducing the symptoms of patients with obsessive-compulsive disorder
Design
Clinical trials with control group, parallel groups, Not blinded, randomized, phase 3, on 30 patients, Randomization was centralized and computerized with concealed randomization sequence carried out at an external site.
Settings and conduct
This study is a not blinded trial. The study sample population is consists of all patients with obsessive-compulsive disorder referring to Farabi Hospital in Kermanshah, that 30 persons will be selected randomly method and randomly will be divided into two groups, intervention group (self-regulation training) and control group. All subjects in all two groups will be re-evaluated by completing questionnaires at baseline, 5 weeks and 2 months after the end of the study (follow-up), will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of obsessive-compulsive disorder according to the DSM-5 by psychiatrist; Age range 18-55 years; Having complete patient satisfaction to participate in research; Low self-regulation score; Minimum level of high school education; Do not use psychotherapy in the last 6 months and when using this treatment. Non-inclusion criteria: Disagreement to participate in the study.
Intervention groups
Intervention group: In addition to standard drug treatment, the intervention group will participate in self-regulation training sessions. These treatment sessions are for 10 sessions (twice a week) and each session is 45 minutes. Control group: The control group will receive only standard drug treatment.
Main outcome variables
Severity of symptoms of obsessive-compulsive disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150822023705N15
Registration date:2022-03-05, 1400/12/14
Registration timing:prospective
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Mostafa Alikhani
Name of organization / entity
Kermanshah University of Medical Sciences - Substance Abuse Prevention Research Center
Country
Iran (Islamic Republic of)
Phone
+98 838264513
Email address
mo.alikhani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-07-05, 1401/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-regulation training on reducing the symptoms of patients with obsessive-compulsive disorder
Public title
The effect of self-regulation training in patients with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of obsessive-compulsive disorder according to the DSM-5 by psychiatrist
Age range 18-55 years
Having complete patient satisfaction to participate in research
Low self-regulation score
Minimum level of high school education
Do not use psychotherapy in the last 6 months and when using this treatment
Exclusion criteria:
Disagreement to participate in the study
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two equal groups (A and B) based on a randomized size 6-block design using random allocation software. To randomly assign 30 patients to the intervention and control groups, 5 different blocks of 6 different letters A and B, which indicate self-regulation training and control groups respectively, will be initially created. These blocks will be numbered from one to five. In the next step, each of these blocks will be randomly selected by performing lottery using 5 cards with numbers 1 to 5 on them. Thus, in each lottery, by selecting a block, a combination of 6 letters of the letters A (Self-regulation training group) and B (control group) will be obtained. At the end of the 5 drawings, after selecting 5 blocks, a total of 30 letters A and B will be obtained
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
Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.KUMS.REC.1400.340
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
Severity of symptoms of obsessive-compulsive disorder
Timepoint
The beginning of the study (baseline), week five and 2 months after the end of the study (follow-up)
Method of measurement
Obsessive-Compulsive Inventory-Revised (OCI-R)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard drug treatment, the intervention group will participate in self-regulation training sessions. These treatment sessions are for 10 sessions (twice a week) and each session is 45 minutes. self-regulation training sessions will be conducted in groups by a psychologist.
Category
Behavior
2
Description
Control group: The control group will receive only standard drug treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Payam Mohammadi
Street address
Farabi Hospital; Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3827 6683
Email
payam.mohammadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3836 0014
Email
khamzehee@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Farnaz Radmehr
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farabi Hospital; Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
radmehr.f12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Khodamorad Momeni
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Social Sciences, Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714673175
Phone
+98 83 3836 8203
Email
khmomeni2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mostafa Alikhani
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farabi Hospital; Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
m.alikhani18@yahoo.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