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The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms

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History
# Registration date Revision Id
2 2024-02-04, 1402/11/15 293645
1 2023-08-23, 1402/06/01 276410
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  • Protocol summary

    Assessment The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Suicide Ideation
    Assessment The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
    بررسی تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای افکار خودکشی
    بررسی تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای نشانگان اضطراب، استرس و افسردگی
    Distress Tolerance Dimensions of Psychological Flexibility and Suicidal Thoughts
    Distress Tolerance Dimensions of Psychological Flexibility and Anxiety, Stress and Depression Symptoms
    تحمل پریشانی ابعاد انعطاف پذیری روانشناختی افکار خودکشی
    تحمل پریشانی ابعاد انعطاف پذیری روانشناختی نشانگان اضطراب، استرس و افسردگی

  • General information

    2023-08-23, 1402/06/01
    2024-02-04, 1402/11/15
    2023-09-23, 1402/07/01
    2024-02-29, 1402/12/10
    empty
    Failure to complete the sample within the desired period of time
    empty
    عدم تکمیل شدن نمونه در مدت زمان مورد نظر
    The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Suicide Ideation
    The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
    تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای افکار خودکشی
    تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای نشانگان اضطراب، استرس و افسردگی
    The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Suicide Ideation
    The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
    تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای افکار خودکشی
    تاثیر آموزش گروهی سرمایه ی روانشناختی بر تحمل پریشانی و انعطاف پذیری روانشناختی افراد دارای نشانگان اضطراب، استرس و افسردگی

  • Health conditions studied

    #1
    R45.851
    F41.2
    Suicidal ideations
    Mixed anxiety and depressive disorder
    Suicide Ideation, Distress Tolerance, Psychological Flexibility
    Anxiety, Stress and Depression Symptoms, Distress Tolerance, Psychological Flexibility
    افکار خودکشی، تحمل پریشانی، انعطاف پذیری روانشناختی
    نشانگان اضطراب و استرس و افسردگی، تحمل پریشانی، انعطاف پذیری روانشناختی

  • Primary outcomes

    #1
    Suicide Ideation Score on Beck's Suicide Thoughts Scale (BSS)
    Score on Anxiety, Stress and Depression Scale (DASS-21)
    نمره فرد در مقیاس افکار خودکشی بک (BSS)
    نمره فرد در مقیاس نشانگان اضطراب، استرس و افسردگی (DASS-21)
    Beck's Suicide Thoughts Scale (BSS)
    Anxiety, Stress and Depression Scale (DASS-21)
    مقیاس افکار خودکشی بک (BSS)
    مقیاس نشانگان اضطراب، استرس و افسردگی (DASS-21)

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd., Chenaran Town
    Street address - Persian: بلوار شهید بهشتی، خیابان شهید بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heyranf4001@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd., Chenaran Town
    Street address - Persian: بلوار شهید بهشتی، خیابان شهید بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heiranf4001@mums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd.
    Street address - Persian: بلوار شهید بهشتی، خیابان شهید بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heyranf4001@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd.
    Street address - Persian: بلوار شهید بهشتی، خیابان شهید بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heiranf4001@mums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd.
    Street address - Persian: بلوار بهشتی، خیابان بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heyranf4001@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farzaneh Heyran
    Full name of responsible person - Persian: فرزانه حیران
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 56, 3rd Beheshti Ave., Beheshti Blvd.
    Street address - Persian: بلوار بهشتی، خیابان بهشتی 3، پلاک 56، طبقه دوم
    City - English: Chenaran
    City - Persian: چناران
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9361946671
    Phone: +98 51 4613 2376
    Mobile: +98 902 292 5945
    Fax:
    Email: heiranf4001@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Assessment The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
Design
The clinical trial has a control group and an intervention group, without blinding, randomized on 32 participants. For randomization the site www.randomization.com will be used.
Settings and conduct
Psychological capital training in Ibn Sina Hospital of Mashhad will be conducted in 10 face-to-face sessions for 90 minutes and once a week on the intervention group. The control group will not receive the intervention. None of the participants know which of the control and intervention groups they are in.
Participants/Inclusion and exclusion criteria
Living in Mashhad No psychiatric drug use Not suffering from Psychological disorders Not getting Psychological therapies in last year No suicide history
Intervention groups
The intervention group (15 people) will attend the meetings at the specified time and hour. Psychological capital training will be conducted in 10 90-minute sessions, one session per week at Ibn Sina Hospital, and will be conducted by a master's student in clinical psychology under the supervision of the supervisor and with the supervision of the sessions. The control group (15 people) will not receive a placebo. After filling the demographic information, psychological flexibility and distress tolerance questionnaires, the control group will not receive any intervention until the end of the research. According to the research ethics, after the end of the research and data analysis, psychological capital training will be implemented for the control group.
Main outcome variables
Distress Tolerance Dimensions of Psychological Flexibility and Anxiety, Stress and Depression Symptoms

General information

Reason for update
Failure to complete the sample within the desired period of time
Acronym
IRCT registration information
IRCT registration number: IRCT20230820059198N1
Registration date: 2023-08-23, 1402/06/01
Registration timing: prospective

Last update: 2024-02-05, 1402/11/16
Update count: 1
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
Farzaneh Heyran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4613 2376
Email address
heiranf4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
Public title
The Effectiveness Psychological Capital Group Training on Distress Tolerance and Psychological Flexibility in people with Anxiety, Stress and Depression Symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Living in Mashhad Informed consent to participate in research
Exclusion criteria:
Suffering from Psychological disorders Taking psychiatric drugs Receiving psychological treatments in the last year A history of suicide attempts
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table using www.randomization.com
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
Iran National Committee for Ethics in Biomedical Research
Street address
No. 56, 3rd Beheshti St., Beheshti Blvd., Chenaran town
City
Chenaran
Province
Razavi Khorasan
Postal code
9361946671
Approval date
2023-08-08, 1402/05/17
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.245

Health conditions studied

1

Description of health condition studied
Anxiety, Stress and Depression Symptoms, Distress Tolerance, Psychological Flexibility
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
Distress Tolerance score on Distress Tolerance Scale (DTS)
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
Distress Tolerance Scale (DTS)

2

Description
Psychological Flexibility score on Psychological Flexibility Dimensions Questionnaire
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
Psychological Flexibility Dimensions Questionnaire

3

Description
Score on Anxiety, Stress and Depression Scale (DASS-21)
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
Anxiety, Stress and Depression Scale (DASS-21)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group (16 people) will attend the meetings at the specified time and hour. Psychological capital training will be conducted in 10 90-minute sessions, one session per week at Ibn Sina Hospital, and will be conducted by a master's student in clinical psychology under the supervision of the supervisor and with the supervision of the sessions.
Category
Other

2

Description
Control group: The control group (15 people) will not receive a placebo. After filling the demographic information, psychological flexibility and distress tolerance questionnaires, the control group will not receive any intervention until the end of the research. According to the research ethics, after the end of the research and data analysis, psychological capital training will be implemented for the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Science
Full name of responsible person
Farzaneh Heyran
Street address
Mashhad University of Medical Sciences, Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
MDS.Dean@mums.ac.ir
Web page address
https://medical.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mouhebati
Street address
University Research and Technology Vice-Chancellor, 3rd floor, University of Medical Sciences, next to Hoveizeh Cinema, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/moavenat/2021-04-06-05-57-55
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
Farzaneh Heyran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 56, 3rd Beheshti Ave., Beheshti Blvd., Chenaran Town
City
Chenaran
Province
Razavi Khorasan
Postal code
9361946671
Phone
+98 51 4613 2376
Email
heiranf4001@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Heyran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 56, 3rd Beheshti Ave., Beheshti Blvd.
City
Chenaran
Province
Razavi Khorasan
Postal code
9361946671
Phone
+98 51 4613 2376
Email
heiranf4001@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Heyran
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 56, 3rd Beheshti Ave., Beheshti Blvd.
City
Chenaran
Province
Razavi Khorasan
Postal code
9361946671
Phone
+98 51 4613 2376
Email
heiranf4001@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
No more information
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
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