Protocol summary

Study aim
The purpose of this research is to determine the effectiveness of cognitive-behavioral therapy in reducing anxiety, depression and increasing self-confidence, obsessive-compulsive disorder. 1- Determining the effectiveness of cognitive behavioral therapy on reducing anxiety
Design
In this research, 30 people with obsessive-compulsive personality disorder were selected as available and then completely randomly (based on lottery) were replaced in two groups of 15 people, the control group and the intervention group. In this way, the sampling was done using lottery, in such a way that all the people were assigned a code and we put them in a container, and then the 15 people who were taken out first were the control group and the next 15 people were replaced in the experimental group.
Settings and conduct
This research includes women suffering from obsessive-compulsive personality disorder who have been identified to care centers for mental and nervous patients covered by welfare to receive specialized help. First, the center is randomly selected from the list of care centers for neuropsychiatric patients in Varamin welfare. In this research, it is an experimental and pre-test-post-test type with a control group. In this research, cognitive behavioral therapy, the independent variable of depression, anxiety, and self-confidence are considered as the dependent variable. The experimental group and the control group were selected from samples that have not yet started taking the drug.
Participants/Inclusion and exclusion criteria
Entry criteria: being a woman-suffering from obsessive compulsive disorder between the ages of 20 and 50
Intervention groups
Intervention group: twice a week for 8 one-hour sessions, they will undergo cognitive behavioral intervention. Control group: But there will be no intervention in the control group
Main outcome variables
Self Confidence; depression; anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240511061735N1
Registration date: 2024-05-21, 1403/03/01
Registration timing: registered_while_recruiting

Last update: 2024-05-21, 1403/03/01
Update count: 0
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Zahra Khodadadi mahabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3621 3569
Email address
zahrakhodadadi09129574109@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-11, 1403/02/22
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the cognitive-behavioral approach on depression, anxiety and self-confidence of women with obsessive-compulsive personality disorder
Public title
Effectiveness of cognitive-behavioral approach on women with obsessive-compulsive personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive-compulsive personality disorder sufferers Based on the minimum score obtained from the stress anxiety depression test, Cooper Smith's self-esteem Women in the age range of 20 to 50 Women who have referred to mental health care centers covered by welfare to receive specialized help Obsessive-compulsive personality disorder was diagnosed by a clinical psychologist
Exclusion criteria:
psychotic disorders such as drug or alcohol abuse, low mental capacity disorders Drug or alcohol abuse Mental retardation Any problem with impulse control Psychosis disorder Bipolar mood disorder
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, 30 people with obsessive-compulsive personality disorder are selected as available. Then random replacement is done by lottery method (one number will be assigned to each sample). We write down the numbers on the paper, then fold them and put them in a container, mix the papers completely and stir them. Then we take out the papers one by one and place one number in the first group and one number in the second group, respectively. Then a random application will be made. In this way, one group is known as the control group and the other group is known as the intervention group. In this way, to randomly determine the control group and the intervention group, we put the collection of each group in two separate envelopes and put them in a container, then randomly remove one envelope from the container and give it to the intervention group and We assign the other envelope to the control group.
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
Ethics committee in research of Semnan Islamic Azad University
Street address
University campus, Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-04-30, 1403/02/11
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.006

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F60.5
ICD-10 code description
Obsessive-compulsive personality disorder

Primary outcomes

1

Description
depression
Timepoint
Before the test, after the test, follow-up
Method of measurement
Daas tes

2

Description
anxiety
Timepoint
Before the test, after the test, follow-up
Method of measurement
Daas test

3

Description
Self Confidence
Timepoint
Before the test, after the test, follow-up
Method of measurement
Cooper Smith Self-Esteem Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receive eight group sessions of cognitive behavioral therapy. The duration of each session will be 60 minutes (two sessions per week) and each session has a specific structure. The method of implementation in this research is experimental and pre-test-post-test type with control group. In this research, cognitive behavioral therapy, the independent variable of depression, anxiety, and self-confidence are considered dependent variables according to the said research plan, its diagram is as follows. Table 3-1 diagram of the research plan examination Group 2T 1X 1T R control group 2T 1X - R 1T means pre-test, 2T means post-test and 1X cognitive behavioral therapy The test group and the control group were selected from samples that have not yet started drug therapy, but according to the existing files, they suffer from obsessive-compulsive personality disorder. The test sample and the control sample do not use drugs during the intervention. Cooper Smith's ego and depression, anxiety, stress scale are implemented and after the intervention, it is implemented based on the cognitive behavioral therapy method and post-test sessions, according to the comparison of the pre-test and post-test results ondepression, anxiety and self-confidence variables. will be done. Obsessive compulsive disorder is the most characteristic disorder according to repetitive behaviors (such as washing hands, maintaining order and order, checking) or mental activities (such as praying, counting, slowly repeating words in silence) that a person feels compelled to perform in Responding to an obsession or according to rules that must be strictly followed. These actions are done with mental activities with the aim of preventing or reducing anxiety or discomfort or preventing some fearful events and situations; However, the said actions and mental activities do not have a realistic relationship with what they were supposed to neutralize or prevent, or they are clearly extreme. The general criteria for obsessive-compulsive personality disorder are perfectionistic, disciplined, and limited emotions, overly concerned with moral issues. and have a flexible value. They often hoard their things and supplies. They work excessively, but rarely complete a task properly, because they entertain themselves too much with details. The severity of the above symptoms is measured using interviews and questionnaires. Related to this disorder, which is implemented in the center, it is determined and the intensity of these behaviors can be seen in people for more than 6 months, and the final determination is made by clinical psychology.
Category
Treatment - Other

2

Description
Control group: no intervention will be done on the control group and they will be placed on the waiting list.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Care Center for Neurological and Psychiatric Patients, Beheshtian Varamin
Full name of responsible person
Gholamreza Kamal Logic Azad
Street address
Varamin, at the end of Taleghani St., after the railway underpass, Hossein Reza St., next to Taxirani
City
Varamin
Province
Tehran
Postal code
33718-86833
Phone
+98 21 3627 5069
Email
Zahrakhodadadi09129574109@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Dr. Mohammad Karim Sohrabi
Street address
Academic campus of Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Email
Zahrakhodadadi09129574109@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Semnan branch
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
Islamic Azad University
Full name of responsible person
Zahra Khodadadi Mahabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Varamin Kohnehgol, Shahada Square, Imamzadeh Yahya Street, No
City
Varamin
Province
Tehran
Postal code
33718-86833
Phone
+98 912 957 4109
Email
Zahrakhodadadi09129574109@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Khodadadi Mahabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Varamin Kohnehgol, Shahada Square, Imamzadeh Yahya Street, No
City
Varamin
Province
Tehran
Postal code
33718-86833
Phone
+98 912 957 4109
Email
Zahrakhodadadi09129574109@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Khodadadi Mahabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Varamin Kohnehgol, Shahada Square, Imamzadeh Yahya Street, No
City
Varamin
Province
Tehran
Postal code
33718-86833
Phone
+98 21 3621 3569
Email
Zahrakhodadadi09129574109@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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