Protocol summary

Study aim
Investigating the effectiveness of mindfulness-based cognitive therapy on mind wandering, cognitive bias, and somatization.
Design
A clinical trial with a control group, blinded, voluntary available sampling, on 23 people in the intervention group
Settings and conduct
At first, the patients who were referred to Aram Clinic in Mashhad were invited to participate in the research. Interested people are identified and randomly divided into experimental and control groups. Then the subjects will be tested with three paper-pencil questionnaires. Once a week, participants in the experimental group will be invited to participate in mindfulness-based cognitive therapy. After the completion of the eight-session treatment, the experimental and control groups will be invited again for the post-test.
Participants/Inclusion and exclusion criteria
The criterion for entering the research is to refer to the public psychological counseling and services center in Beh Aram Mashhad, the presence of behavioral problems, mild psychological injuries such as mild depression, family and marital problems, mild psychological stress and confusion, and behavioral problems. Exclusion criteria include severe and major psychiatric disorders such as psychotic disorders, major depressive disorder, bipolar disorder, personality disorders, and substance abuse. Entry criteria are measured using self-reports and review of clients' files, and exit criteria are measured using clinical file review, physician's diagnosis, and brief psychiatric clinical interview based on DSM-5.
Intervention groups
The research sample comprises 45 people who refer to Aram Public Psychological Services and Counseling Center in Mashhad. After matching, 23 people will be assigned to the intervention group and 22 will be assigned to the control group.
Main outcome variables
Somatization, Cognitive Bias, Mind-Wandering

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231005059629N1
Registration date: 2023-10-18, 1402/07/26
Registration timing: registered_while_recruiting

Last update: 2023-10-18, 1402/07/26
Update count: 0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Zaynab Raisianzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3821 8403
Email address
zaynab.raisianz1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-16, 1402/07/24
Expected recruitment end date
2023-12-04, 1402/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mindfulness based on cognitive therapy, Mind wandering, cognitive bias, Somatization
Public title
Mindfulness based on cognitive therapy, Mind wandering, cognitive bias, Somatization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of behavioral problems mild psychological injuries such as mild depression Family and marital problems Having mild psychological stress, confusion, and behavioral problems. Referring to the Aram public psychological counseling and services center in Mashhad,
Exclusion criteria:
Severe and major psychiatric disorders such as psychotic disorders, major depressive disorder, bipolar disorder, personality disorders, Substance abuse
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Semnan University of Medical Sciences
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.SEMUMS.REC.1402.126

Health conditions studied

1

Description of health condition studied
Somatization
ICD-10 code
F45.0
ICD-10 code description
Somatization disorder

2

Description of health condition studied
Mind-wandering
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Cognitive Bias
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Somatization
Timepoint
Before the Intervention and after the implementation of the eight-week intervention program
Method of measurement
Spoth & Dush Health Concerns Questionnaire-54

2

Description
Cognitive Bias
Timepoint
Before Intervention and after implementation of eight-weeks intervention program
Method of measurement
Woody, Chambless & Glass Cognitive Bias scale (1997)

3

Description
Mind-Wandering
Timepoint
Before the Intervention and after the implementation of the eight-week intervention program
Method of measurement
Carriere, Seli and Smilek Mind Wandering Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mindfulness-based cognitive therapy has been implemented in this group. The treatment protocol is based on Segal et al. (2018), which includes 8 treatment sessions, and each session includes 90 minutes of attendance and 45 minutes of home practice. Before and after the intervention, the participants were tested with somatization, cognitive bias, and mental wandering questionnaires.
Category
Treatment - Other

2

Description
Control group: No intervention is carried out on this group. Before and after the intervention in intervention group, the control group memrbers participants were tested with somatization, cognitive bias, and mental wandering questionnaires.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beh Aram Counseling and general psychological Center
Full name of responsible person
Dr Elham Pour Afrouz
Street address
No. 697, between 29 and 31 vakilabad., Vakil abad Blvd., Daneshjoo., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188988463
Phone
+98 902 209 9122
Email
elhampourafrouz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
ِDr. Majid Mir Mohammadkhani
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
The University of Semnan
Full name of responsible person
Zeinab Raiesian Zadeh
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 4, Sarafrazan 20 St., Sarafrazan Blvd., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177134461
Phone
+98 51 3821 8403
Email
Zaynab.raisianz1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zaynab Raisianzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.4, sarafrazan 20 ave., sarafrazan blvd., mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177134461
Phone
+98 51 3821 8403
Fax
Email
Zaynab.raisianz1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zaynab Raisianzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.4, sarafrazan 20 ave., sarafrazan blvd., mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177134461
Phone
+98 51 3821 8403
Fax
Email
Zaynab.raisianz1@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
The data have been collected for a master's thesis, and only their descriptive and inferential analysis report will be published
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
Loading...