Protocol summary

Study aim
Determining the relationship between training attention allocation techniques and mindfulness-based on thought-action fusion in patients with anxiety and stress syndromes.
Design
The clinical trial has a control group, with parallel groups, without blinding, simple randomization, on 42 clients. An online random number table is used for randomization.
Settings and conduct
The intervention group will attend 10 training sessions on designated days at Mashhad Medical Sciences Campus. In the first 5 sessions, they will learn attention allocation techniques, and in the next 5, detachemindfulness techniques. After the training, they will fill out the thought fusion questionnaire again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent, age between 18 and 50 years, anxiety and stress measures according to Dass-21, not participating in other treatments or classes, not having psychiatric disorders or taking psychiatric medications. Exclusion criteria: symptoms of depression, major mental disorders, severe medical illness, anxiety disorders caused by medical and general conditions, receiving psychotherapy in the last 6 months, not having criteria for anxiety syndrome according to the DASS-21 questionnaire 7. Non-participation in Meetings and homework
Intervention groups
In this research, the intervention group will participate in five group training sessions focused on detached mindfulness and attention allocation. Following the sessions, participants' fusion thoughts will be measured using the TFI and MCQ30 questionnaires. The control group will not receive any intervention and will complete the same questionnaires again after one month.
Main outcome variables
The fusion of thought and action, anxiety and stress syndromes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240420061534N1
Registration date: 2024-05-15, 1403/02/26
Registration timing: prospective

Last update: 2024-05-15, 1403/02/26
Update count: 0
Registration date
2024-05-15, 1403/02/26
Registrant information
Name
Fatemeh joneydiepour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3626 6328
Email address
joneidipourf4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group teaching technique of attention training technique and detached- mindfulness on the thought action fusion in students with anxiety and stress syndrome
Public title
The effect of teaching techniques of attention allocation and mindfulness in students with anxiety and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Having the criteria of anxiety and stress symptoms according to the analysis and interpretation of the Dass-21 questionnaire. Being at least 18 years old and at most 50 years old Not participating in other educational and therapeutic classes at the same time Not suffering from psychiatric disorders such as: schizophrenia, bipolar, addiction, etc., Not receiving psychiatric drugs.
Exclusion criteria:
Having depression symptoms Suffering from major psychiatric disorders Suffering from any type of severe medical disease that prevents the continuation of treatment, for example: severe heart diseases, respiratory problems, etc. Suffering from anxiety disorders caused by medical and general conditions Received psychotherapy in the last 6 months Not having criteria for anxiety symptoms according to the DASS-21 questionnaire Not participating in meetings and doing homework
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Once the required sample size is collected, the names of the individuals are arranged in alphabetical order and assigned codes from 1 to 42. Next, two groups - intervention and control - are defined in the program. Each time a subject is selected, the program randomly places them into either the intervention or control group. This process is repeated until all research samples are allocated randomly into the two groups.
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
U 023, Block 2, Baharestan Apt, Medical Science Complex, End of Bahonar St, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1403.007

Health conditions studied

1

Description of health condition studied
Anxiety and Stress syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Thought-action fusion
Timepoint
Before the intervention and after the intervention
Method of measurement
Measuring thought-action fusion by means of TFI questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive 10 sessions of training on attention allocation and detached - mindfulness techniques.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling Center of Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Joneydipour
Street address
U 023, Block 2, Baharestan Apt, Medical Science Complex, End of Bahonar St, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 936 929 4381
Email
joneidipourf4012@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Research and fanavari Deputy, Qureshi Building, Next to Hoizeh cinema, University st
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
Email
vcresrearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Joneydipour
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
U 023, Block 2, Baharestan Apt, Medical Science Complex, End of Bahonar St, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 936 929 4381
Email
joneidipourf4012@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Joneydipour
Position
university student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
U 023, Block 2, Baharestan Apt, Medical Science Complex, End of Bahonar St, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 936 929 4381
Email
joneidipourf4012@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Joneydipour
Position
Univesity student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
U 023, Block 2, Baharestan Apt, Medical Science Complex, End of Bahonar St, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 936 929 4381
Email
joneidipourf4012@mums.ac.ir

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
Due to ethical principles and considerations, the data of the participants will not be published.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The report will include information on the software used, the method of statistical analysis, and the results obtained.
When the data will become available and for how long
Start of access: after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of non-identifiable individual data is allowed if it is analyzed by another part of metacognitive studies and metabeliefs and influence on it.
From where data/document is obtainable
email: fatemehjoneydie@gmail.com
What processes are involved for a request to access data/document
After reading the analysis and explanation provided, the applicant should be able to reach a correct understanding and then, considering the limitations of the research, have an accurate estimate of the data available to him. And also the requester must be able to provide the correct and accessible purpose of the request for the data.
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