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The effectiveness of cognitive-behavioral therapy on automatic Negative thoughts, irrational beliefs and worry in people with generalized anxiety disorder

Protocol summary

Study aim
General objectives: Determining the effectiveness of cognitive-behavioral therapy on self-negative thoughts, irrational beliefs and anxiety in people with generalized anxiety disorder areSub-objectives:
Design
The present study is a quasi-experimental study with a pre-test-post-test study with a control group. In this method, the experimental group receives cognitive-behavioral therapy and the control group does not receive any intervention. Both groups respond to pre-test and post-test at the same time. And our statistical population is 30 clients with generalized anxiety disorder
Settings and conduct
The statistical population of this study will include all patients with generalized anxiety disorder to clinics in Rasht who are eligible to participate in this study. Will be mentioned To select a subject, 30 clients are randomly selected and placed in two experimental groups (15 people) and a control group (15 people). All clients complete the ATQ Negative Self-Thinking Questionnaire, Jones's Irrational Beliefs, Pennsylvania State Concern, and Generalized Anxiety Disorder as a pre-test.
Participants/Inclusion and exclusion criteria
Entry requirements for participants who received a diagnosis of generalized anxiety disorder by a therapist (psychiatrist) in terms of DSM5 diagnostic criteria, are at least 20 years old and have a significant score on the questionnaires
Intervention groups
All clients complete the ATQ Negative Self-Esteem Questionnaire, Jones Irrational Beliefs, Pennsylvania State Concern, and Generalized Anxiety Disorder as a pre-test.
Main outcome variables
اGeneralized Anxiety Disorder, Negative Self Thoughts, Irrational Beliefs, Anxiety, Cognitive Behavioral Therapy

General information

Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number: IRCT20210609051523N1
Registration date: 2021-06-29, 1400/04/08
Registration timing: prospective

Last update: 2021-06-29, 1400/04/08
Update count: 0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Samaneh Rabinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4242 7292
Email address
samaneh1441@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral therapy on automatic Negative thoughts, irrational beliefs and worry in people with generalized anxiety disorder
Public title
Determining the Effectiveness of Cognitive Behavioral Therapy on automatic Negative Thoughts, Irrational Beliefs, and worry in People with Generalized Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should receive a diagnosis of generalized anxiety disorder by a therapist (psychiatrist) based on the DSM5 diagnostic criteria. Participants are eligible to participate in the study if they have not received any intervention Be at least 20 years old
Exclusion criteria:
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that 30 patients with generalized anxiety disorder in the centers are randomly selected according to the inclusion criteria. The randomization tool is a random table of numbers that the researcher on one of the numbers in the random table. Hands down the numbers and moves them to the right and down. Finally, he records the numbers and assigns them to two experimental groups (15 people) and a control group (15 people) whose numbers have already been determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lahijan Azad University Ethics Committee
Street address
Sheikh Zahed St., Sheikh Zahed 7, Baharan 7
City
Lahijan
Province
Guilan
Postal code
۴۴۱۵۹۸۶۱۵۴
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.IAU.LIAU.REC.1400.015

Health conditions studied

1

Description of health condition studied
Pervasive Anxiety Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Generalized Anxiety Disorder Score in Generalized Anxiety Disorder Questionnaire (GADQ)
Timepoint
Before and after the intervention
Method of measurement
Generalized Anxiety Disorder Questionnaire (GADQ)

2

Description
Negative Self-Thoughts Score in the Negative Self-Thought Questionnaire (ATQ)
Timepoint
Before and after the intervention
Method of measurement
Negative Self Thought Questionnaire (ATQ)

3

Description
Irrational Beliefs Score on the Jones Irrational Beliefs Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Jones Irrational Beliefs Questionnaire

4

Description
Concern score on the Pennsylvania Concern Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Pennsylvania State Concern Questionnaire

Secondary outcomes

1

Description
Reduce pervasive anxiety disorder
Timepoint
Before and after the intervention
Method of measurement
Generalized Anxiety Disorder Questionnaire (GAD_Q)

2

Description
Reduce negative self-thoughts
Timepoint
Before and after the intervention
Method of measurement
Negative Self-Esteem Questionnaire (ATQ)

3

Description
Reduce irrational beliefs
Timepoint
Before and after the intervention
Method of measurement
Jones Irrational Beliefs Questionnaire

4

Description
Reduce anxiety
Timepoint
Before and after the intervention
Method of measurement
Pennsylvania Concern Questionnaire

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Royesh Mehr Family Counseling Center
Full name of responsible person
Alireza Nezamdoost
Street address
Golsar Intersection - Navab St. - Corner of Valiasr Alley - Parseh Building - 3rd Floor - No. 6
City
Rasht
Province
Guilan
Postal code
4415986154
Phone
+98 13 3211 2776
Email
info@salamati24.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Waqar Lahiji
Street address
Sheikh Zahed St., Sheikh Zahed 7, Baharan 7
City
Lahijan
Province
Guilan
Postal code
4415986154
Phone
+98 13 4242 7292
Email
samaneh1441@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic azad university Lahijan 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
Samaneh rabinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sheikh Zahed St., Sheikh Zahed 7, Baharan 7
City
Lahijan
Province
Guilan
Postal code
4415986154
Phone
+98 13 4242 7292
Email
samaneh1441@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samaneh rabinejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sheikh Zahed St., Sheikh Zahed 7, Baharan 7
City
Lahijan
Province
Guilan
Postal code
4415986154
Phone
+98 13 4242 7292
Email
samaneh1441@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samaneh rabinejad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Sheikh Zahed St., Sheikh Zahed 7, Baharan 7
City
Lahijan
Province
Guilan
Postal code
4415986154
Phone
+98 13 4242 7292
Email
samaneh1441@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
Title and more details about the data/document
After studying the documents, it is registered in the research system and in a separate article, we mention the scientific information of the participants and the effect of the intervention.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only researchers have access to the data
Under which criteria data/document could be used
Only scientific data and documents with access to the source are accessible and personal data is unauthorized
From where data/document is obtainable
Refer to Lahijan Islamic Azad University for data
What processes are involved for a request to access data/document
Access the information as soon as possible with the following email address samaneh1441@gmail.com
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