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Comparing the effectiveness of mindfulness-based stress reduction, meta-cognition, acceptance and commitment training on social anxiety, locus of behavioral control, executive function, self-compassion and emotion regulation in adults who stutter

Protocol summary

Study aim
Determining the effectiveness of mindfulness training based on stress reduction, meta-cognition and acceptance and commitment on social anxiety, source of behavior control, executive function, self-compassion and emotion regulation in adults with stuttering
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 60 patients
Settings and conduct
The study will be carried out in the psychological and speech therapy clinics of Isfahan city. People are selected from among the clients with adult stuttering, and then people are randomly placed in the test and control groups without knowing the allocation of the groups.
Participants/Inclusion and exclusion criteria
Entry requirements:1- Adults must be between 18 and 40 years old, 2- Stuttering must be confirmed by a speech and language pathologist, 3- They must have at least a diploma, 4- They must not suffer from psychiatric disorders (except social anxiety) at the same time. Conditions of non-entry: 1- He is participating in another psychotherapy. 2- Not interested in cooperation.
Intervention groups
In the intervention groups, the people present receive psychological and behavioral training and learn ways to change their behavior according to their conditions. The control group does not receive any of the psychological and behavioral training of the other three groups.
Main outcome variables
Reducing social anxiety, improving executive functioning, improving the source of behavioral control, increasing self-compassion, increasing emotion regulation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230215057422N1
Registration date: 2023-03-04, 1401/12/13
Registration timing: prospective

Last update: 2023-03-04, 1401/12/13
Update count: 0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Alireza Salehpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5323 9632
Email address
alirezasalehpoor@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of mindfulness-based stress reduction, meta-cognition, acceptance and commitment training on social anxiety, locus of behavioral control, executive function, self-compassion and emotion regulation in adults who stutter
Public title
Investigating the effect of psychological interventions on stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Adults must be between 18 and 40 years old, 2- Stuttering must be confirmed by a speech and language pathologist, 3- They must have at least a diploma, 4- They must not suffer from psychiatric disorders (except social anxiety) at the same time.
Exclusion criteria:
1- He is participating in another group psychotherapy, 2- He is not interested in cooperation.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization: Referees entered into the study will be stratified by gender and then randomly placed in groups. After stratification, a lottery will be used to randomly place people in groups. The lottery will be done by people other than the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of the allocation of the study groups, as well as the person who is in charge of the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University- Isfahan(Khorasgan) Branch
Street address
University Blvd , Arghwanieh , J St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-12-19, 1401/09/28
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.289

Health conditions studied

1

Description of health condition studied
Stuttering Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social anxiety score in Canver's social anxiety questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, 45 days after the end of the intervention
Method of measurement
To evaluate the social anxiety of the participants, the Social anxiety questionnaire of Conor (2000) will be used.

2

Description
The score of locus of control in the locus of control questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, 45 days after the end of the intervention
Method of measurement
To evaluate the locus of control of the participants' behavior, the scale of the Locus of Control of the Behavior of Craig et al. (1984) will be used.

3

Description
Executive function score in the executive function questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, 45 days after the end of the intervention
Method of measurement
To evaluate the Executive function of the participants, the Behavioral rating questionnaire of executive functions (Brief, 2000, adult comparative version) will be used.

4

Description
The self-compassion score in the Neff self-compassion questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, 45 days after the end of the intervention
Method of measurement
To evaluate the Self-compassion of the participants, the Neff (2003) Self-compassion scale will be used.

5

Description
Emotion regulation score in Gross and John questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, 45 days after the end of the intervention
Method of measurement
To evaluate the Emotion Regulation of the participants, the emotion regulation questionnaire of Gross and John (2003) will be used.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: mindfulness training based on stress reduction, 8 90-minute training sessions once a week
Category
Treatment - Other

2

Description
The second intervention group: meta-cognitive training, 8 90-minute training sessions once a week
Category
Treatment - Other

3

Description
The third intervention group: acceptance and commitment training, 8 90-minute training sessions once a week
Category
Treatment - Other

4

Description
Control group: without receiving any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Raha comprehensive rehabilitation center
Full name of responsible person
Mohammad Saadatnia
Street address
Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8168633333
Phone
+98 31 3668 5838
Email
alirezasalehpoor.st@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad university Isfahan branch
Full name of responsible person
Isfahan Azad University Research Assistant
Street address
University Blvd, Arghwanieh, J St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
Info@khuisf.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal financial resources
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University, Isfahan branch
Full name of responsible person
AlirezaSalehpoor
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16, 44 alley, 45 meter st.
City
Shahreza
Province
Isfehan
Postal code
8615733333
Phone
+98 31 5323 9632
Email
Alirezasalehpoor.st@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Isfahan branch
Full name of responsible person
AlirezaSalehpoor
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16, 44 alley, 45 meter st.
City
Shahreza
Province
Isfehan
Postal code
8615733333
Phone
+98 31 5323 9632
Email
alirezasalehpoor.st@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Isfahan branch
Full name of responsible person
Alirezasalehpoor
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16, 44 alley, 45 meter st.
City
Shahreza
Province
Isfehan
Postal code
8615733333
Phone
+98 31 5323 9632
Email
Alirezasalehpoor.st@gmail.com

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A part of individual data, such as the main result, can be shared. The study protocol can be shared in summary.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data is accessible for further research on the subject.
From where data/document is obtainable
To receive data and information, call 09130955248 or refer to the address of Isfahan Islamic Azad University, Counseling Department.
What processes are involved for a request to access data/document
After checking the validity of the person's employment in a scientific institution or university and knowing the purpose of data access, access will be possible within a few days.
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