Protocol summary

Study aim
This research seeks the following goals: A) The main goal: 1- Determining the comparison of the effectiveness of positive points practice training based on mindfulness and cognitive behavioral training on psychological well-being, life satisfaction, future anxiety and perceived stress of gifted students 2- Providing the necessary guidelines and suggestions to mental health practitioners, counseling and in schools and education.
Design
Clinical trial with control group, with parallel groups, on 45 patients, SPSS software will be used.
Settings and conduct
Girls Highschool The method is experimental. The research design is semi-experimental with a pre-test-post-test design with a control group and a follow-up stage.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- Low score in psychological well-being questionnaire 2- Students have physical symptoms (headache, nausea, discomfort and pain in the chest and abdomen, palpitations, sweating, weakness) 3- Desire and informed consent 4- Having physical health to the extent of participating in the class and taking the test through a psychological interview Exit criteria: 1- Absence of more than 2 sessions in the training course 2- Children of divorce 3- Completing incomplete and invalid questionnaires
Intervention groups
Two experimental groups and one control group are randomly divided into three groups of 15 people, and pre-test and post-test are conducted on all three groups, and only two experimental groups are trained, and the control group does not receive training.
Main outcome variables
Strengthening positivity, controlling negative thoughts and feelings, emphasizing strengths, stress, increasing impact, increasing health and psychological well-being in students and creating relaxation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230306057632N1
Registration date: 2023-05-13, 1402/02/23
Registration timing: registered_while_recruiting

Last update: 2023-05-13, 1402/02/23
Update count: 0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Fatemeh Kamran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5465 9551
Email address
dabir_kamran@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-06-09, 1402/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness mindfulness-based strengths practice MBSP and cognitive behavioral training on psychological well-being, life satisfaction, future anxiety and perceived stress in gifted students
Public title
Comparison of the effectiveness mindfulness-based strengths practice MBSP and cognitive behavioral training
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Low score in the psychological well-being questionnaire Students have physical symptoms (headache, nausea, discomfort and pain in the chest and abdomen, palpitations, sweating, weakness) Desire and informed consent Having physical health to the extent of participating in class and taking the test through a psychological interview
Exclusion criteria:
Absence of more than 2 sessions in the training course Children of divorce Completing incomplete and invalid questionnaires
Age
From 13 years old to 18 years old
Gender
Female
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
National Biomedical Research Ethics System
Street address
Islamic Azad University, Sari branch Km 7 of Darya Road (Farahabad), Khazar Square
City
Sari
Province
Mazandaran
Postal code
۱۹۴-۴۸۱۶۴
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.IAU.SARI.REC.1401.253

Health conditions studied

1

Description of health condition studied
Psychological well-being
ICD-10 code
F40-F48
ICD-10 code description
Mental and behavioural disorders

2

Description of health condition studied
The level of satisfaction with life
ICD-10 code
F90-F98
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence

3

Description of health condition studied
Future anxiety and dark anxiety
ICD-10 code
F30-F39
ICD-10 code description
F30-F39 Mood [affective] disorders

4

Description of health condition studied
Stress
ICD-10 code
F40-F48
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
Life satisfaction score in Diner's questionnaire
Timepoint
At the beginning of the study and 8 weeks later and 45 days later
Method of measurement
Diener's Life Satisfaction Questionnaire

2

Description
Psychological well-being score in Ryff's questionnaire
Timepoint
At the beginning of the study and 8 weeks later and 45 days later
Method of measurement
Ryff psychological well-being questionnaire

3

Description
Dark anxiety score in Zaleski, Sobol-Kwapinska questionnaire
Timepoint
At the beginning of the study and 8 weeks later and 45 days later
Method of measurement
Zaleski, Sobol-Kwapinska, Przepiorka & Meisner dark anxiety questionnaire

4

Description
Perceived stress score in Cohen's questionnaire
Timepoint
At the beginning of the study and 8 weeks later and 45 days later
Method of measurement
Cohen's Perceived Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Experimental group 1 who are trained to practice strengths based on mindfulness.
Category
N/A

2

Description
Intervention group: experimental group 2 who are subjected to cognitive behavioral training.
Category
N/A

3

Description
Control group: This group does not receive any training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Talented High School for Girls
Full name of responsible person
Kusoom Babaei
Street address
Mousavi St, Khairian Blvd
City
Nowshahr
Province
Mazandaran
Postal code
4673174867
Phone
+98 11 5465 9551
Email
dabir_kamran@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Naghipour
Street address
Islamic Azad University, Sari branch, Khazar Square, km 7 of Darya Road (Farahabad),Khazar Sq, Sari
City
Sari
Province
Mazandaran
Postal code
۱۹۴-۴۸۱۶۴
Phone
+98 11 3303 2891
Fax
+98 11 3303 3751
Email
dabir_kamran@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Kamran
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.17, Aryan Street, Rezaei Street, Rajaei Street
City
Kelarabad
Province
Mazandaran
Postal code
4673174867
Phone
+98 11 5465 9551
Email
dabir_kamran@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Kamran
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No17,Aryan, Rezaee St, Rajaee St
City
Kelar Abad
Province
Mazandaran
Postal code
4673174867
Phone
+98 11 5465 9551
Email
dabir-kamran@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Kamran
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No17, Aryan,Rezaee St, Rajaee St
City
Kelar Abad
Province
Mazandaran
Postal code
4673174867
Phone
+98 11 5465 9551
Email
dabir_kamran@yahoo.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
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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