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The effectiveness of cognitive-behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being and Social Adjustment in students with generalized anxiety disorder

Protocol summary

Study aim
Evaluating the impact of cognitive-behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being, and social adjustment in students with generalized anxiety disorder
Design
This research includes pre-test, post-test, and follow-up assessments in both the experimental and control groups
Settings and conduct
This study, set to take place in the Education Department of Region 1 in Sanandaj, will involve the selection of 30 female students diagnosed with generalized anxiety disorder. Subsequently, they will be divided into two groups: an experimental group that will undergo a 10-session intervention, and a control group that will not receive any intervention after obtaining the necessary permits
Participants/Inclusion and exclusion criteria
This research will be conducted for middle school students who have generalized anxiety disorder
Intervention groups
intervention group: In this research, the stress management protocol based on the cognitive-behavioral approach by Antony et al. (2007) and other sources will be used for the experimental group. The sessions are outlined as follows: 1. Description of stressors and responses, 2. The impact of stress on thoughts 3. Exploring the connection between thoughts and emotions, 4. Identification of negative thoughts 5. Substituting logical thoughts for irrational ones, 6. Training in effective stress coping, 7. Implementing effective coping responses, 8. Anger management training, 9. Teaching assertiveness in interpersonal relationships, 10. Social support and social network maintenance techniques. Control group: In this study, the control group participated in the pre-test, post-test and follow-up, but no educational or psychological intervention was implemented for this group
Main outcome variables
Emotion Regulation Strategies, Life Expectancy, Mental Well-Being and Social Adjustment

General information

Reason for update
Acronym
اثربخشی آموزش مدیریت استرس به شیوه شناختی رفتاری
IRCT registration information
IRCT registration number: IRCT20230417057932N2
Registration date: 2024-01-10, 1402/10/20
Registration timing: registered_while_recruiting

Last update: 2024-01-10, 1402/10/20
Update count: 0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
Anvar Dastbaz
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3372 5050
Email address
anvardastbaz@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being and Social Adjustment in students with generalized anxiety disorder
Public title
The effectiveness of cognitive- behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being and Social Adjustment in students with generalized anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Middle school student and attendance at school during the research period being between the ages of 14-18 years Having generalized anxiety disorder (diagnosed based on the Spitzer Generalized Anxiety Disorder Questionnaire by Spitzer Et al. (2006) and an interview conducted by an experienced psychologist according to the criteria of DSM-5-TR).
Exclusion criteria:
presence of a chronic and disabling disease presence of concurrent mental disorders Participation in similar courses with an independent variable in the past or concurrently. Consumption of Psychiatric Medications
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
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
Research Ethics Committees of Islamic Azad University-Sanandaj Branch
Street address
Sanandaj - Adab St. - central site of Islamic Azad University, Sanandaj branch
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.IAU.SDJ.REC.1402.019

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Emotion Regulation Strategies
Timepoint
Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention)
Method of measurement
Emotion regulation scale (Gross and Jones, 2003)

2

Description
Life Expectancy
Timepoint
Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention)
Method of measurement
Miller Hope Scale (1988)

3

Description
Mental Well-Being
Timepoint
Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention)
Method of measurement
Mental well-being questionnaire (Keyes & Magyar-Moe, 2003)

4

Description
Social Adjustment
Timepoint
Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention)
Method of measurement
California Social Adjustment Questionnaire (Clark et al.,1993)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Intervention group: In this study, the cognitive-behavioral stress management training protocol is used for the intervention group. The first session: description of stressors and responses to them, awareness of possible health consequences, introduction of the protocol to the participants, awareness of the physical effects of stress, muscle relaxation for 16 muscle groups. The second session: the effect of stress on emotions and behavior, awareness of the effect of stress on thoughts, muscle relaxation for 8 muscle groups. Third session: communication of thoughts and emotions, awareness of imaging technique, diaphragmatic breathing, muscle relaxation for 4 muscle groups. The fourth session: identifying negative thoughts and cognitive distortions, solutions to challenge negative thoughts, visualization and passive muscle relaxation, the fifth session: replacing logical thoughts with illogical ones, spontaneous training to feel heaviness and warmth. Sixth session: training to cope effectively with stress, spontaneous training for heart rate, breathing, abdomen and forehead. Seventh session: Implementation of effective countermeasures of self-generated training along with visualization and self-induction. Session 8: Anger management training and mantra meditation, repetition and meditation practice. Ninth session: Teaching expressiveness in interpersonal relationships, breathing counting meditation. Session 10: Social support and social network maintenance techniques, creating a personal stress management plan.
Category
Behavior

2

Description
Control group: In this study, the control group participated in the pre-test, post-test and follow-up, but no educational or psychological intervention was implemented for this group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling center of Sanandaj city education
Full name of responsible person
Ali Soleimani
Street address
No. 10, Ferdowsi Street, Azadi Square, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6648578634
Phone
+98 87 3323 4715
Email
a_solimani2003@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Qader Bayzidi
Street address
No. 1, Adab St, Islamic Azad University, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8684
Email
q_bayzidi@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
University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home66

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
Anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home

Person responsible for updating data

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Anvar Dastbaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
15175 -66177
Phone
009887133664600
Email
anvardastbaz@uok.ac.ir
Web page address
https://uok.ac.ir/~anvardastbaz/home

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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, an intervention program, including sessions accompanied by grade margins, is presented during the pre-test, post-test, and follow-up stages without specifying the participants' names. Additionally, the final results are disclosed.
When the data will become available and for how long
After one month from the publication of the results.
To whom data/document is available
for everyone
Under which criteria data/document could be used
It is not necessary conditions.
From where data/document is obtainable
email
What processes are involved for a request to access data/document
1 Month
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