History
# Registration date Revision Id
3 2024-11-24, 1403/09/04 321665
2 2024-06-14, 1403/03/25 305045
1 2024-06-01, 1403/03/12 303647
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  • General information

    40
    50
    Suffering from obsessive-compulsive disorder
    Education at least diploma
    Age over 18 years
    Not suffering from personality disorders and other Axis 1 disorders (except obsessive-compulsive disorder)
    Absence of trauma at present or in the past 6 months
    Consent to participate in rese
    Suffering from obsessive-compulsive disorder
    Education at least diploma
    Age over 18 years
    Not suffering from personality disorders
    Absence of trauma at present or in the past 6 months
    Consent to participate in rese
    دارای اختلال وسواس فکری-عملی
    تحصیلات حداقل دیپلم
    سن بالای 18 سال
    مبتلا نبودن به اختلالات شخصیت و دیگر اختلال‌های محور یک(به غیر از اختلال وسواس فکری-عملی)
    عدم وجود تروما در حال حاضر یا 6 ماه گذشته
    رضایت به مشارکت در پژوهش
    ابتلا به اختلال وسواس فکری-عملی
    تحصیلات حداقل دیپلم
    سن بالای 18 سال
    مبتلا نبودن به اختلالات شخصیت
    عدم وجود تروما در حال حاضر یا 6 ماه گذشته
    رضایت به مشارکت در پژوهش
    Abuse of drugs or alcohol
    Taking psychiatric medication
    Abuse of drugs or alcohol
    Taking psychiatric medication
    Suicidal thoughts
    سوءمصرف مواد مخدر یا الکل
    مصروف داروی روانپزشکی
    سوءمصرف مواد مخدر یا الکل
    مصروف داروی روانپزشکی
    داشتن افکار خودکشی

Protocol summary

Study aim
Investigating the effectiveness of combined schema therapy and dialectical behavior therapy for obsessive-compulsive disorder
Design
60 people with obsessive-compulsive disorder were selected by purposive sampling and then randomly divided into three experimental groups of 15 people and a control group of 15 people.
Settings and conduct
Farad, all four groups in the psychiatric office first filled the dysfunctional attitudes and mental health questionnaire as a pre-test, then all three intervention groups received treatments and the control group did not receive treatment. The test was taken from the subjects.
Participants/Inclusion and exclusion criteria
Entry criteria: suffering from obsessive-compulsive disorder, over 18 years of age, at least a high school diploma. Non-entry criteria: suffering from one and two mental disorders other than obsessive-compulsive disorder, currently or in the last six months, involvement with trauma, drug and alcohol abuse, taking psychiatric drugs
Intervention groups
There are three intervention groups: the first group receives only dialectical behavior therapy. The second group receives only schema therapy. The third group receives first dialectical behavior therapy and then schema therapy.
Main outcome variables
Dysfunctional attitudes, Mental health, Symptoms of obsessive-compulsive disorder

General information

Reason for update
Complete the entered information
Acronym
IRCT registration information
IRCT registration number: IRCT20240517061824N1
Registration date: 2024-06-01, 1403/03/12
Registration timing: retrospective

Last update: 2024-11-24, 1403/09/04
Update count: 2
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Sara Ghafarfaraji
Name of organization / entity
Aryan institute of science and technology
Country
Iran (Islamic Republic of)
Phone
+98 11 3235 5000
Email address
sara.ghafarfaraji@aryan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2024-02-09, 1402/11/20
Scientific title
Comparing the effectiveness of dialectical behavior therapy, schema therapy and the Combination of both therapies on dysfunctional attitudes, mental health and symptoms of people with obsessive-compulsive disorder
Public title
Comparing the effectiveness of dialectical behavior therapy, schema therapy and the Combination of both therapies on dysfunctional attitudes, mental health and symptoms of people with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from obsessive-compulsive disorder Education at least diploma Age over 18 years Not suffering from personality disorders Absence of trauma at present or in the past 6 months Consent to participate in rese
Exclusion criteria:
Abuse of drugs or alcohol Taking psychiatric medication Suicidal thoughts
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: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple Randomization Unit: Individual Among the people referred to the psychiatric office, 60 people who were diagnosed with obsessive-compulsive disorder by clinical interview and the Yale-Brown Obsession Questionnaire were selected, then they were randomly assigned to three experimental groups and one control group, as follows. A lottery was held and each person took the papers in which one of the behavioral therapy, schema therapy, combined and control groups were written from inside the box and belonged to that group, and this was done until the completion of each group, which was 15 people. .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of babol university of medical sciences
Street address
Ganj Afrooz Street, University Square
City
BABOL
Province
Mazandaran
Postal code
47176-47745
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.MUBABOL.REC.1403.012

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
Dysfunctional Attitudes
Timepoint
Before the start of the therapy and immediately after the end of the therapy
Method of measurement
DAS Dysfunctional Attitudes Questionnaire

2

Description
Mental Health
Timepoint
Before the start of the therapy and immediately after the end of the therapy
Method of measurement
Goldberg General Health Questionnaire-28

3

Description
Symptoms of obsessive-compulsive disorder
Timepoint
Before the start of the therapy and immediately after the end of the therapy
Method of measurement
Yale Brown Obsessive-Compulsive Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Dialectical behavior therapy
Category
Treatment - Other

2

Description
Intervention group 1: Dialectical behavior therapy
Category
Treatment - Other

3

Description
Intervention group 3: combined therapy (schema therapy with dialectical behavior therapy)
Category
Treatment - Other

4

Description
Control group: did not receive any treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Roshd clinic
Full name of responsible person
Nasrin Eghbali Ghazi Jahani
Street address
Alley Laleh 3, street Tawheed 56, western Beltway
City
BABOL
Province
Mazandaran
Postal code
4716688461
Phone
+98 11 4442 2160
Email
nasrinegbali@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ARYAN Institute of Science and Technology
Full name of responsible person
Mohammad Reza Fadavi Amiri
Street address
Corner of University Street, Kamerbandi Amirkola
City
BABOL
Province
Mazandaran
Postal code
47317-76437
Phone
+98 11 3235 5000
Email
info@aryan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ARYAN Institute of Science and Technology
Proportion provided by this source
100
Public or private sector
Private
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
Psychology office
Full name of responsible person
Sara Ghafarfaraji
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 6, West 17th Alley, Firdous Gharb Blvd
City
Tehran
Province
Tehran
Postal code
1484967154
Phone
+98 21 4411 7238
Email
saraghaffar1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychiatric Office
Full name of responsible person
Sara Ghafarfaraji
Position
clinical psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 6, Central 20th Street, Naser Hejazi Blvd
City
Tehran
Province
Tehran
Postal code
1484967154
Phone
+98 21 4411 7238
Email
saraghaffar1990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
ARYAN Institute of Science and Technology
Full name of responsible person
Sara Ghafarfaraji
Position
Master's degree
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
corner of University Street, Amirkola
City
BABOL
Province
Mazandaran
Postal code
47317-76437
Phone
+98 11 3235 5000
Email
saraghaffar1990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A part of the study data, which includes the results of the effectiveness of the treatments, is shared through the articles extracted from the thesis
When the data will become available and for how long
Access started immediately after the articles were published in 1403
To whom data/document is available
Study data will be available to all people
Under which criteria data/document could be used
No decision has been made on this yet
From where data/document is obtainable
No decision has been made on this yet
What processes are involved for a request to access data/document
No decision has been made on this yet
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