Protocol summary

Study aim
Effectiveness of emotional distress tolerance skill training based on acceptance and commitment and psychological immunization program training on quality of life, emotion regulation, optimism and hope in adolescents
Design
A clinical trial with a control group and two parallel intervention groups, not blinded, was used on 45 samples by drawing the names of schools and then using a randomization table.
Settings and conduct
The study was conducted at the level of Rafsanjan schools in the form of a pre-test and a post-test without blinding, so that after selecting a sample randomly, each sample was placed in a group and within 21 days of intervention on Intervention groups have been conducted and then the post-test is done
Participants/Inclusion and exclusion criteria
Second year high school students Female gender Personal and family satisfaction of the participant having a physical illness having a mental illness being a single parent
Intervention groups
Intervention group 1: Acceptance and commitment-based therapy group training, which will be the acceptance and commitment-based therapy group training program based on the Ismaili model (2009), in ten 90-minute sessions. Intervention group 2: Psychological Immunization Program training, which in the present study means the psychological immunization program training group based on Meikenbaum's (2009) perspective, which will be taught in 12 90-minute sessions. Control group: a group that does not receive any intervention
Main outcome variables
Quality of life, optimism and hope, emotional regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240719062467N1
Registration date: 2024-11-21, 1403/09/01
Registration timing: registered_while_recruiting

Last update: 2024-11-21, 1403/09/01
Update count: 0
Registration date
2024-11-21, 1403/09/01
Registrant information
Name
Fahime Rezvani Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4756
Email address
fahime.rezvaninejad.1401@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-20, 1403/08/30
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of emotional distress tolerance skill training based on acceptance and commitment and psychological immunization program training on quality of life, emotion regulation, optimism and hope in adolescents
Public title
Effectiveness of emotional distress tolerance skill training based on acceptance and commitment and psychological immunization program training on quality of life, emotion regulation, optimism and hope
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Second year high school students Female gender Personal and family satisfaction of the participant
Exclusion criteria:
Having a physical illness Having a mental illness Being a single parent
Age
From 14 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample consists of 45 students of the tenth grade of girls' schools who are selected by simple random allocation in such a way that by assigning numbers to each school and using the number table of five schools, and again with the help of the number table from the students of each school 9 A person is selected and with the help of Excel formulas, we divide the selected students into three equal groups of 15 people randomly.
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 committee of Islamic Azad University, Kerman branch
Street address
Islamic Azad University, Imam Ali Boulevard
City
Kerman
Province
Kerman
Postal code
7635168111
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.IAU.KERMAN.REC.1402.095

Health conditions studied

1

Description of health condition studied
quality of life
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Excitement regulation
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Optimism and hope
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
It is the score that the research subjects will get in the 20-question emotion regulation questionnaire of Watson et al.
Timepoint
Measuring emotional regulation before the intervention and after 21 days of psychological intervention
Method of measurement
the 20-question emotion regulation questionnaire of Watson et al

2

Description
It is the score that the subjects will get in Schneider's Hope Questionnaire and Shier and Carver's Optimism Questionnaire.
Timepoint
Measuring hope and optimism before intervention and after 21 days of psychological intervention
Method of measurement
Schneider's Hope Questionnaire and Shier and Carver's Optimism Questionnaire

3

Description
The overall score obtained by the subjects will be the short form of the World Health Organization quality of life scale
Timepoint
Measuring the quality of life before the intervention and after 21 days of psychological intervention
Method of measurement
World Health Organization quality of life scale with short form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Acceptance and commitment-based therapy group training, which will be the acceptance and commitment-based therapy group training program based on the Ismaili model (2009), in ten 90-minute sessions.
Category
Prevention

2

Description
Intervention group 2: Psychological Immunization Program training, which in the present study means the psychological immunization program training group based on Meikenbaum's (2009) perspective, which will be taught in 12 90-minute sessions.
Category
Prevention

3

Description
Control group: a group that does not receive any intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Education
Full name of responsible person
Hossein Shafiei Mehdiabadi
Street address
West Shariati Street, Mullah Sadra
City
Rafsanjan
Province
Kerman
Postal code
7718871471
Phone
+98 34 3426 4501
Email
fahime.rezvaninejad.1401@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshid Khosropoor
Street address
Islamic Azad University, Sarbagh Road, University Square, Zarand
City
zarand
Province
Kerman
Postal code
7617717151
Phone
+98 34 3345 0856
Email
farshid2002@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
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
Islamic Azad University
Full name of responsible person
Fahime Rezvani Nejad
Position
Doctoral student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 35, Akbar Nesabzadeh Street, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7635168111
Phone
+98 34 3428 4756
Fax
Email
fahime.rezvaninejad.1401@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahime Rezvani Nejad
Position
Doctoral student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 35, Akbar Nesabzadeh Street, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7635168111
Phone
+98 34 3428 4756
Fax
Email
fahime.rezvaninejad.1401@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahime Rezvani Nejad
Position
Doctoral student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 35, Akbar Nesabzadeh Street, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7635168111
Phone
+98 34 3428 4756
Fax
Email
fahime.rezvaninejad.1401@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The raw data file extracted inside the questionnaires, the analysis fileStatistical data
When the data will become available and for how long
The access period starts 8 months after the results are published
To whom data/document is available
Only for researchers and employees in academic institutions
Under which criteria data/document could be used
In order to use this data during communication, necessary arrangements are made regarding the permitted analysis method. They can only be used for academic research
From where data/document is obtainable
They can make necessary arrangements to receive data by sending emails and communicating.
What processes are involved for a request to access data/document
After the request is made by the applicant and confirmation is received from the supervisor, the data file is sent via email fahime.rezvaninejad.1401@gmail.com
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