Protocol summary

Study aim
1- Introduction of virtual reality exposure therapy for the treatment of patients with obsessive-compulsive disorder with religious content (impure and purity). 2- Localization of virtual reality treatment
Design
A clinical trial, a control group with parallel groups (three groups), a blind spot and random substitution, Sample size 60 people and 3 months follow up
Settings and conduct
Place of research: Psychiatric Clinic and Clinical Psychology of Tehran Psychiatric Institute Psychologists and psychiatrists in Tehran's medical centers are requested to refer patients to their therapist if they are satisfied.
Participants/Inclusion and exclusion criteria
Entry Criteria: 1- The presence of obsessive-compulsive diagnostic criteria - based on SCID-I. 3- Content of obsessive compulsive and purity. 4. Literacy to read and write. 5- Having at least 18 years and up to 50 years. Exit criteria 1- Having symptoms of psychotic disorders, substance abuse and full-scale criteria, except for major and mild depression and generalized anxiety. 2. Having serious suicidal thoughts and history of doing so. 3. Have a history of heart problems. 4. The existence of two axis criteria based on SCID-II
Intervention groups
1) Cognitive-behavioral therapy based on religious aspects (Islamic);   2) Cognitive-behavioral therapy based on virtual reality encounter;   3) Cognitive-behavioral cognitive therapy based on religious (Islamic) aspects along with virtual reality encounters;   4) Control group.
Main outcome variables
the severity of obsessive-compulsive symptoms, depression, anxiety, obsession-obsessive-compulsive, obsessive beliefs (thoughts), severity of guilty feelings, and general performance of obsessive-compulsive disorder-practical with religious content (impure and purity).

General information

Reason for update
Acronym
درمان شناختی رفتاری مبتنی بر واقعیت مجازی وسواس نجس و پاکی
IRCT registration information
IRCT registration number: IRCT20190601043781N1
Registration date: 2020-02-16, 1398/11/27
Registration timing: registered_while_recruiting

Last update: 2020-02-16, 1398/11/27
Update count: 0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Abbas Ramezanifarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1668
Email address
ramezanifarani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive Behavioral Therapy Based on Religious Islamic Aspects Cognitive Behavioral Integrative Therapy with Virtual Reality Exposure and Cognitive Behavioral Integrative Therapy Based on Religious Islamic Aspects with Virtual Reality Exposure in Patients with Obsessive-Compulsive Disorder with Religious Content Cognitive Behavioral Therapy Based on
Public title
The Effect of Cognitive-Behavioral Therapy Based on Religious (Islamic) Aspects with Virtual Reality Exposure on Obsessive-Compulsive Disorder with Religious Content
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The existence of obsessive-compulsive disorder diagnostic criteria based on SCID-I. The existence of obsessive-compulsive and purity substance. Literacy reading and writing. At least 18 years and maximum 50 years. Lack of receive psychological treatment for one month before entering the research. Signature of written consent for participation in the research.
Exclusion criteria:
Having symptoms of psychotic disorders, substance abuse and full-scale criteria, except for major and mild depression and generalized anxiety. Having serious suicidal thoughts and history of doing so. Having a history of heart problems. The existence of two criteria based on SCID-II
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 15
A patient with obsessive-compulsive disorder with najes and paki content
Randomization (investigator's opinion)
Randomized
Randomization description
The desired sample will be selected first by a non-randomized, targeted (objective-based) sampling method from among the members of the statistical community and then subjected to randomized sampling in three experimental groups and one control group. The choice of these patients for replacement in groups of four after the completion of the interview process by clinical psychologists will be designed and evaluated based on the criteria for entry and exit, using a randomized method (using the list of patients and replacement in groups 4 ) Will be carried out. For example, the first 4 people in the list are distributed among the four groups, and the next 4 will be grouped in the same way, and until the end.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in this study are divided into four groups, and none of the members of the group are aware of the allocation of members of the groups, which means that the study will be one on the one hand.
Placebo
Not used
Assignment
Parallel
Other design features
The study of the effect of virtual reality exposure as a new treatment for mental disorders

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Academic / Regional Committee on Ethics in Biomedical Research of Iran University of Medical Science
Street address
Mansuori St. Niyayesh St, Sattarghan
City
Tehran
Province
Tehran
Postal code
1445613111
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.IUMS.REC.1398.551

Health conditions studied

1

Description of health condition studied
A patient with obsessive-compulsive disorder with najes and paki content
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Severity of obsessive-compulsive disorder, symptoms of depression and anxiety, obsessive cognitive beliefs, scrupulosity, guilt feeling
Timepoint
3 months
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Cognitive-behavioral therapy based on religious aspects (Islamic)
Category
Other

2

Description
Intervention group:2) Cognitive-behavioral therapy based on virtual reality encounter
Category
Other

3

Description
Intervention group: 3) Cognitive-behavioral cognitive therapy based on religious (Islamic) aspects along with virtual reality encounters
Category
Other

4

Description
Control group: Control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
clinics of School of Behavioral Sciences and Mental Health‍ Clinics
Full name of responsible person
Dr. Mohammad Bagher Saberi Zafarghandi
Street address
Sattar Khan St, Niyayesh St, Mansouri St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1668
Email
ramezanifarani.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Jalil Koohpayehzadeh
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14496، 14535
Phone
+98 21 8670 1021
Email
ivco_app@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Abbas Ramezani Farani
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sattar Khan St, Niyayesh St, Mansouri St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1667
Email
ramezanifarani.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Ramezani Farani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sattar Khan St, Niyayesh St, Mansouri St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1667
Email
ramezanifarani.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Ramezani Farani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sattar Khan St, Niyayesh St, Mansouri St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1667
Email
ramezanifarani.a@iums.ac.ir

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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Questionnaire data will be presented to the university in the final report and will be included in the article
When the data will become available and for how long
Three months after completion
To whom data/document is available
researchers
Under which criteria data/document could be used
If anyone wants to do a systematic review study
From where data/document is obtainable
Iranian University of Medical Sciences Spiritual Health Research Center as well as a published journal
What processes are involved for a request to access data/document
E-mail the author of the article or visit the Research Assistant of Spiritual Health Research Center of Iran University of Medical Sciences
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