Protocol summary

Study aim
Determining the effectiveness of metacognitive therapy on mind reading, autobiographical memory, and cognitive emotion regulation in students with social anxiety
Design
A clinical trial, including pre-test, post-test, and follow-up assessments, will be conducted on two groups (experimental and control) with a sample size of 30. Randomization of the research sample will be achieved using a table of random numbers
Settings and conduct
This research will be conducted in the education and training organization of region 1 in Sanandaj. After obtaining permission, 30 female students with social anxiety disorder will be selected and assigned to two groups (experimental and control). The experimental group will receive a 10-session intervention, while the control group will not undergo any intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Having social anxiety disorder. 2. Declaring consent to participate in the research. Exclusion criteria: 1. Lack of consent for intervention participation 2. Having other disorders 3. Participation in similar courses
Intervention groups
The intervention group consists of students diagnosed with social anxiety disorder who receive a pre-test, post-test, follow-up, and metacognitive therapy intervention based on the protocol by Wells et al. (2009) in 10 sessions lasting 90 minutes each The comparison group (control group) includes students with social anxiety who undergo pre-test, post-test, and follow-up assessments but do not receive any intervention
Main outcome variables
Mind Reading, Autobiographical Memory, and cognitive emotion regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230417057932N3
Registration date: 2024-02-04, 1402/11/15
Registration timing: registered_while_recruiting

Last update: 2024-02-04, 1402/11/15
Update count: 0
Registration date
2024-02-04, 1402/11/15
Registrant information
Name
Anvar Dastbaz
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3372 5050
Email address
anvardastbaz@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-12, 1402/10/22
Expected recruitment end date
2024-02-11, 1402/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of metacognitive therapy on mind reading, Autobiographical memory and cognitive emotion regulation in students with social anxiety
Public title
The effectiveness of metacognitive therapy on social anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Middle school students and attendance in school during the research period Being in the age range of 14 to 18 years Being diagnosed with social anxiety disorder, determined through the Liebowitz Social Anxiety Scale (1998) and an interview conducted by an experienced psychologist following the criteria of DSM-5-TR
Exclusion criteria:
Having a chronic and disabling medical condition Having concurrent comorbid mental disorders Participating in similar courses either in the past or concurrently with the independent variable Consumption of neurologic and psychiatric medications
Age
From 14 years old to 18 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 manner, numerical ranging from 1 to 30 are randomly assigned to all participants in the research study. Subsequently, even numbers will be randomly assigned to one group, and odd numbers to another group. Finally, one of the groups will be randomly selected for the intervention group, while the other group will be designated as 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
Research Ethics Committees of University of Kurdistan
Street address
Central building, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran
City
Sanandej
Province
Kurdistan
Postal code
15175 -66177
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.UOK.REC.1402.024

Health conditions studied

1

Description of health condition studied
Social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
Mind reading
Timepoint
Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention)
Method of measurement
Baron-Cohen mind reading test (2001)

2

Description
Autobiographical memory
Timepoint
Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention)
Method of measurement
Autobiographical Memory Test (AMT), Williams and Broadbent (1986)

3

Description
cognitive emotion regulation
Timepoint
Pre-test (before intervention), post-test (after intervention), follow-up (2 months after intervention)
Method of measurement
Garnevsky and Kraij (2006) cognitive emotion regulation Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: In this study, the intervention group will receive 10 sessions of cognitive-behavioral therapy based on the protocol by Wells et al. (2009). Session 1: Introduction and preparation, implementation of the downward arrow technique, initiating challenge with dysfunctional beliefs, practicing fragmented mindfulness.Session 2: Continuing the challenge with dysfunctional beliefs, postponing worry.Session 3: Presenting opposing evidence, examining and stopping avoidant behaviors, reversing avoidant behaviors.Session 4: Initiating challenge with beliefs related to danger, attempting to lose control or harm oneself using the worry experiment. Session 5: Continuing the challenge with beliefs about the dangerousness of worry. Implementing the challenge experiment with beliefs related to danger in the therapy session.Session 6: Continuing the challenge with beliefs about danger, emphasizing reversing any remaining non-adaptive strategies, behavioral experiments to challenge beliefs about danger. Session 7: Initiating challenge with positive beliefs. Session 8: Continuing the challenge with positive beliefs. Implementing the non-compliance strategy in the therapy session. Session 9: Working on reversing remaining symptoms. Implementing the effective strategy, initiating work on a new plan.Session 10: Working on the treatment plan (preventing relapse), strengthening the alternative plan, and explaining it clearly with examples.
Category
Behavior

2

Description
Control Group: In this study, the control group will participate in pre-test, post-test, and follow-up assessments, but no intervention will be implemented for this group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling Center, Directorate General of Education and Training
Full name of responsible person
Ali Soleimani
Street address
No. 10, Ferdowsi Street, Azadi Square, Sanandaj, Iran.
City
Sanandej
Province
Kurdistan
Postal code
6648578634
Phone
+98 87 3323 4715
Email
a_solimani2003@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Ali Akbar Mozafari
Street address
Central building, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandej
Province
Kurdistan
Postal code
15175 -66177
Phone
+98 87 3378 6993
Email
info@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kurdistan
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
University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home66

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandej
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home

Person responsible for updating data

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandej
Province
Kurdistan
Postal code
15175 -66177
Phone
009887133664600
Email
anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home

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
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