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Comparison of the efficacy of three versus five sessions of grief counseling on general health, quality of life and intensity of grief in family members of the COVID-19 victims: A multi-center randomized controlled trial

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History
# Registration date Revision Id
2 2022-12-05, 1401/09/14 248746
1 2020-06-30, 1399/04/10 141211
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  • Protocol summary

    The primary outcome of this study is general health and the secondary outcomes are quality of life and the intensity of grief in family members of the COVID- 19 victims.
    The primary outcome of this study is the intensity of grief and the secondary outcomes are general health and quality of life in family members of the COVID- 19 victims.
    پیامد اولیه در این مطالعه سلامت عمومی ‌و پیامدهای ثانویه کیفیت زندگی و شدت سوگ اعضای خانواده متوفیان ناشی از بیماری کووید 19 هستند.
    پیامد اولیه در این مطالعه شدت سوگ و پیامدهای ثانویه سلامت عمومی ‌و کیفیت زندگی اعضای خانواده متوفیان ناشی از بیماری کووید 19 هستند.

  • General information

    empty
    Displacement of the primary and secondary outcome variables
    empty
    جابه جایی متغیر پیامد اولیه با ثانویه

  • Primary outcomes

    #1
    The primary outcome of this study is the general health score of the family members of the COVID-19 victims measured with the General Health Questionnaire (GHQ-28).
    The primary outcome of this study is the intensity of grief score of the family members of the COVID-19 victims measured with the Grief Intensity Scale (GIS).
    پیامد اولیه در این مطالعه نمره سلامت عمومی اعضای خانواده متوفیان ناشی از بیماری کووید 19 اندازه گیری شده با پرسشنامه سلامت عمومی GHQ-28 می باشد.
    پیامد اولیه در این مطالعه نمره شدت سوگ اعضای خانواده متوفیان ناشی از بیماری کووید 19 اندازه گیری شده با مقیاس شدت سوگ GIS می باشد.
    General Health Questionnaire (GHQ-28): This questionnaire was developed for screening the psychiatric disorders and has been commonly used in research in various countries. It includes 4 sub-scales of somatic symptoms, anxiety and insomnia, social dysfunction and depressive symptoms. The 28-item Persian version of GHQ was validated in a study by Noorbala et al. on Tehran population (aged 15 and more) and it showed a good reliability and validity for epidemiological studies. The 28-item version of the GHQ consists of four-choice questions, ranges from a 'better than normal' option, through a 'same as usual' and a 'more than usual' to a 'much worse than usual' option, and is scored on a 0-1-2-3 Likert scale. A higher score indicates poorer general health and the maximum score is 84.
    The Grief Intensity Scale (GIS): The GIS is a scale proposed by Prigerson et al. and is consisted of 12 questions measuring the thoughts, emotions, and behaviors of individuals who have recently lost an important person. This scale represents the severity of reactions of the bereaving individual. It facilitates clinicians to be able to assess the risk of an individual being later diagnosed with prolonged grief disorder after the loss of a loved one. The first two questions of this scale question the time elapsed since the death of a loved one and the decline in performance. The sum of the scores of the next 10 Likert-scale questions, each of which is answered with never, at least once a month, once a week, once a day, and several times a day, is analyzed as a grief intensity score. Each item receives a score of 1-5. A higher score represents a higher intensity in grief symptoms. We conducted a pilot study to investigate the validity and reliability of the Persian version of GIS and estimate the mean and standard deviation of the grief intensity score of the bereaved persons due to Covid-19. The face and content validity of the questionnaire was confirmed by the expert panel. The Cronbach's alpha of 0.92 and intraclass correlation coefficient of 0.87 indicated the good internal consistency and test-retest reliability of the Persian version of GIS.
    پرسشنامه سلامت عمومی‌(GHQ-28) [General Health Questionnaire]: این پرسشنامه برای غربالگری و سرند اختلالات روانپزشکی ساخته شده و به شکل رایجی در پژوهش‌های کشورهای مختلف مورد استفاده قرار گرفته است. شامل 4 خرده مقیاس علائم جسمانی، علائم اضطرابی و اختلال خواب، کارکرد اجتماعی و علائم افسردگی می‌باشد. نسخه فارسی 28 آیتمی GHQ در مطالعه نوربالا و همکاران روی جمعیت 15 ساله و بالاتر شهر تهران اعتباریابی شد و پایایی و روایی مناسب برای بررسی‌های اپیدمیولوژیک نشان داد. شکل 28 سؤالی GHQ شامل پرسش‌های چهارگزینه‌ای خیر، کمی، زیاد و خیلی زیاد است و در نمره‌گذاری آن به روش لیکرتی به شکل 0-1-2-3 می‌باشد. نمره بالاتر بیانگر سلامت عمومی‌نامطلوب و بیشینه نمره پرسشنامه 84 است.
    مقیاس شدت سوگ [The Grief Intensity Scale] (GIS): GIS مقیاسی است که توسط Prigerson و همکاران ایجاد شده است و شامل 12 سوال برای سنجش افکار، احساسات و رفتار متداول افرادی است که اخیراً فرد مهمی را از دست داده اند. این مقیاس نشان دهنده شدت واکنش مخاطب نسبت به سوگ است. این ابزار تشخیصی به ارزیابی خطر ابتلا به اختلال سوگ طولانی مدت (PGD) در پی مرگ عزیزان، کمک می‌کند. دو سوال اول این مقیاس زمان سپری شده از مرگ عزیز و کاهش عملکرد را مورد سوال قرار می دهد. مجموع نمرات 10 سوال بعدی در مقیاس لیکرت که به هر یک از آن‌ها با گزینه های هرگز، حداقل ماهی یک بار، هفته ای یک بار، روزی یک بار و چند بار در روز پاسخ داده می شود، به عنوان نمره شدت سوگ تحلیل می شود. به هر گویه امتیاز بین 1 تا 5 تعلق می‌گیرد. نمره بالاتر نشان دهنده شدت بالاتر در علائم سوگ است.ما یک مطالعه پایلوت برای بررسی روایی و پایایی نسخه فارسی GIS و برآورد میانگین و انحراف معیار نمره شدت سوگ افراد داغدیده به دلیل کووید-19 انجام دادیم. روایی صوری و محتوایی پرسشنامه توسط گروه متخصصان تایید شد. آلفای کرونباخ 0.92 و ضریب همبستگی درون رده ای 0.87 بیانگر همسانی درونی و پایایی آزمون- بازآزمون مناسب نسخه فارسی GIS بود.

  • Secondary outcomes

    #1
    The intensity of grief score of family members of the COVID-19 victims measured with the Grief Intensity Scale (GIS)
    The general health score of family members of the COVID-19 victims measured with the General Health Questionnaire (GHQ-28)
    نمره شدت سوگ اعضای خانواده متوفیان ناشی از بیماری کووید 19 اندازه گیری شده با مقیاس شدت سوگ GIS
    نمره سلامت عمومی اعضای خانواده متوفیان ناشی از بیماری کووید 19 اندازه گیری شده با پرسشنامه سلامت عمومی‌ GHQ-28
    Grief Intensity Scale (GIS): This scale has 11 items created by Prigerson and evaluates the thoughts, feelings, and behaviors of people who have lost someone important. This scale shows the intensity of the audience's reaction to grief. The scale is meant to capture the grieving respondent’s intensity of his or her reaction to the loss. This diagnostic tool helps to assess a person’s risk of developing prolonged grief disorder (PGD) following the death of a loved one. Each question is answered with options at all, at least once, once a week, once a day and several times a day, and each option is graded 1 to 5, respectively. Prior to the start of the present study, the validity and reliability of this scale will be confirmed by face and content validity, test-retest reliability and internal consistency.
    General Health Questionnaire (GHQ-28): This questionnaire was developed for screening the psychiatric disorders and has been commonly used in research in various countries. It includes 4 sub-scales of somatic symptoms, anxiety and insomnia, social dysfunction and depressive symptoms. The 28-item Persian version of GHQ was validated in a study by Noorbala et al. on Tehran population (aged 15 and more) and it showed a good reliability and validity for epidemiological studies. The 28-item version of the GHQ consists of four-choice questions, ranges from a 'better than normal' option, through a 'same as usual' and a 'more than usual' to a 'much worse than usual' option, and is scored on a 0-1-2-3 Likert scale. A higher score indicates poorer general health and the maximum score is 84.
    مقیاس شدت سوگ (GIS) [Grief Intensity Scale]: این مقیاس دارای 11 گویه می‌باشد که توسط Prigerson ایجاد شده است و افکار، احساسات و رفتارهای متداول افرادی را که فرد مهمی‌را از دست داده اند، ارزیابی می‌کند. این مقیاس شدت واکنش مخاطب نسبت به سوگ را نشان می‌دهد. این ابزار تشخیصی به ارزیابی خطر ابتلا به اختلال سوگ طولانی مدت (PGD) در پی مرگ عزیزان، کمک می‌کند. هر سوال با گزینه‌های اصلا، حداقل یک بار، یک بار در هفته، یک بار در روز و چندین بار در روز پاسخ داده می‌شود و هر گزینه به ترتیب از 1 تا 5 نمره گذاری می‌شود. قبل از شروع مطالعه‌ی حاضر، روایی و پایایی این مقیاس به روش‌های روایی صوری، محتوایی، پایایی آزمون باز آزمون و ثبات درونی تایید خواهد شد.
    پرسشنامه سلامت عمومی‌(GHQ-28) [General Health Questionnaire]: این پرسشنامه برای غربالگری و سرند اختلالات روانپزشکی ساخته شده و به شکل رایجی در پژوهش‌های کشورهای مختلف مورد استفاده قرار گرفته است. شامل 4 خرده مقیاس علائم جسمانی، علائم اضطرابی و اختلال خواب، کارکرد اجتماعی و علائم افسردگی می‌باشد. نسخه فارسی 28 آیتمی GHQ در مطالعه نوربالا و همکاران روی جمعیت 15 ساله و بالاتر شهر تهران اعتباریابی شد و پایایی و روایی مناسب برای بررسی‌های اپیدمیولوژیک نشان داد. شکل 28 سؤالی GHQ شامل پرسش‌های چهارگزینه‌ای خیر، کمی، زیاد و خیلی زیاد است و در نمره‌گذاری آن به روش لیکرتی به شکل 0-1-2-3 می‌باشد. نمره بالاتر بیانگر سلامت عمومی‌نامطلوب و بیشینه نمره پرسشنامه 84 است.

  • Recruitment centers

    #1
    Name of recruitment center - English: Arak University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Dr. Mahdiyeh Salehi
    Full name of responsible person - Persian: دکتر مهدیه صالحی
    Street address - English: A'lam-Al-Hoda St.
    Street address - Persian: خیابان علم الهدی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: ٣٨١٩٦٩٣٣٤٥
    Phone: +98 86 3313 6055
    Fax:
    Email: info@arakmu.ac.ir
    Web page address:
    Name of recruitment center - English: Arak University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Dr. Mahdiyeh Salehi
    Full name of responsible person - Persian: دکتر مهدیه صالحی
    Street address - English: A'lam-Al-Hoda St.
    Street address - Persian: خیابان علم الهدی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 38196693345
    Phone: +98 86 3313 6055
    Fax:
    Email: info@arakmu.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of the efficacy of three versus five sessions of grief counseling on general health, quality of life and severity of grief in family members of the COVID-19 victims
Design
The study will be a multi-center randomized controlled trial with parallel groups and double-blind on 120 family members of the COVID-19 victims in the 10 medical sciences universities. The Balanced Block Randomization, stratified by center, will be used with the RANDBETWEEN command in Excel software.
Settings and conduct
This study will be conducted in selected health care centers of Tehran, Iran, Shiraz, Mashhad, Kerman, Tabriz, Ahvaz, Gilan, Golestan and Arak Universities of Medical Sciences. Face-to-face counseling sessions will be held individually by the mental health experts, in full compliance with the health guidelines and social distance in a suitable environment located in the comprehensive health care centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the first-degree relatives of COVID-19 victim; the age between 15 and 64 years old; have literacy and be able to understand and speak Persian; provide written consent to enter the study. Exclusion criteria: receiving any other grief interventions and psychological or pharmacological treatments before or at the same time as the research; severe physical or mental disorders (delusions, hallucinations, lack of awareness of time and place) that make intervention impossible; suicidal ideation or self-harm; alcohol and drug use.
Intervention groups
Participants will be randomly divided into two equal groups, one will receive 5 grief counselling sessions and the other will receive 3 sessions.
Main outcome variables
The primary outcome of this study is the intensity of grief and the secondary outcomes are general health and quality of life in family members of the COVID- 19 victims.

General information

Reason for update
Displacement of the primary and secondary outcome variables
Acronym
IRCT registration information
IRCT registration number: IRCT20200505047305N1
Registration date: 2020-06-30, 1399/04/10
Registration timing: registered_while_recruiting

Last update: 2022-12-11, 1401/09/20
Update count: 1
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
noushin khademoreza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6862
Email address
nooshinkreza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of three versus five sessions of grief counseling on general health, quality of life and intensity of grief in family members of the COVID-19 victims: A multi-center randomized controlled trial
Public title
Grief counseling in family members of the COVID-19 victims
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The first-degree relatives of COVID-19 victim The age between 15 and 64 years old Have literacy and be able to understand and speak Persian. Provide written consent to enter the study.
Exclusion criteria:
Receiving any other grief interventions and psychological or pharmacological treatments before or at the same time as the research. Severe physical or mental disorders (delusions, hallucinations, lack of awareness of time and place) that make intervention impossible. Suicidal ideation or self-harm Alcohol and drug use
Age
From 15 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to randomly assignment of 120 participants from 10 universities into two study groups, Stratified Balanced Block Randomization, will be used. Randomization will be done separately for each University of Medical Sciences. Out of a maximum of 20 forms for the six size blocks, including three members of the intervention group A: five-session grief counseling and three members of the intervention group B: three-session grief counseling, using the RANDBETWEEN(1,20) command in Excel software, 2 blocks will be randomly selected for each university and a random sequence will be created. According to the random sequence created, participants will be divided equally into two groups. The randomization will be done by the study's head office and will be announced to the universities.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because of the type of study, it is not possible to blind the participants about intervention. The outcome evaluators will not be one of the consultants and will be blind about the belonging of individuals to the intervention groups. The data analyst will not be aware of the coding nature of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.IUMS.REC.1399.272

Health conditions studied

1

Description of health condition studied
Greif
ICD-10 code
F43.20
ICD-10 code description
Adjustment disorder, unspecified

Primary outcomes

1

Description
The primary outcome of this study is the intensity of grief score of the family members of the COVID-19 victims measured with the Grief Intensity Scale (GIS).
Timepoint
Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
Method of measurement
The Grief Intensity Scale (GIS): The GIS is a scale proposed by Prigerson et al. and is consisted of 12 questions measuring the thoughts, emotions, and behaviors of individuals who have recently lost an important person. This scale represents the severity of reactions of the bereaving individual. It facilitates clinicians to be able to assess the risk of an individual being later diagnosed with prolonged grief disorder after the loss of a loved one. The first two questions of this scale question the time elapsed since the death of a loved one and the decline in performance. The sum of the scores of the next 10 Likert-scale questions, each of which is answered with never, at least once a month, once a week, once a day, and several times a day, is analyzed as a grief intensity score. Each item receives a score of 1-5. A higher score represents a higher intensity in grief symptoms. We conducted a pilot study to investigate the validity and reliability of the Persian version of GIS and estimate the mean and standard deviation of the grief intensity score of the bereaved persons due to Covid-19. The face and content validity of the questionnaire was confirmed by the expert panel. The Cronbach's alpha of 0.92 and intraclass correlation coefficient of 0.87 indicated the good internal consistency and test-retest reliability of the Persian version of GIS.

Secondary outcomes

1

Description
The quality of life score in physical and mental performance of family members of the COVID-19 victims measured with the Short Form Quality of Life Questionnaire (SF-12)
Timepoint
Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
Method of measurement
Short Form-12 Quality of Life (SF-12): This questionnaire is the short version of SF-36 that has two general components of physical and mental performance with 12 questions and 8 sub-scales of physical functioning (2 questions), bodily pain (2 questions), role limitation due to physical problems (1 question), general health (1 question), Energy and vitality (1 question), social functioning (1 question), role limitation due to mental health problems (2 questions) and perceived mental health (2 questions). After performing the necessary calculations, the overall score of each person is obtained in two components: physical performance and mental performance. After translation for the Iranian population, the validity and the reliability of this questionnaire has been confirmed and standardized by Montazeri et al. with Cronbach's alpha of 0.72.

2

Description
The general health score of family members of the COVID-19 victims measured with the General Health Questionnaire (GHQ-28)
Timepoint
Assessments will take place three times, including before the intervention begins, one month and three months after the end of the last counseling session.
Method of measurement
General Health Questionnaire (GHQ-28): This questionnaire was developed for screening the psychiatric disorders and has been commonly used in research in various countries. It includes 4 sub-scales of somatic symptoms, anxiety and insomnia, social dysfunction and depressive symptoms. The 28-item Persian version of GHQ was validated in a study by Noorbala et al. on Tehran population (aged 15 and more) and it showed a good reliability and validity for epidemiological studies. The 28-item version of the GHQ consists of four-choice questions, ranges from a 'better than normal' option, through a 'same as usual' and a 'more than usual' to a 'much worse than usual' option, and is scored on a 0-1-2-3 Likert scale. A higher score indicates poorer general health and the maximum score is 84.

Intervention groups

1

Description
First intervention group: In five-session grief counseling group, the order and type of sessions are as following: 1. Preliminary session: Preliminary evaluation and consultation 2. The first session: Flexible evaluation of event and increasing understanding of loss 3. The second session: coping with grief and finding the meaning 4. The third session: recovery, adaptation to life without the deceased 5. Fourth session: Assessing the grief process, returning to life without the deceased • Sessions will be held weekly and will be followed up and evaluated in person in one and three months after the last session. The intervention of grief counseling will be held according to the protocol by trained mental health experts, individually and in person at the health center.
Category
Other

2

Description
Second intervention group: In three-session grief counseling group, the order and type of sessions are as following: 1. Preliminary session: Preliminary evaluation and consultation 2. The first session: Flexible evaluation of event and increasing understanding of loss, coping with grief and finding the meaning 3. The second session: recovery, adaptation to life without the deceased, Assessing the grief process, returning to life without the deceased • The two sessions followed by the preliminary's will be held once every two weeks and will be followed up and evaluated in person one and three months after the last session. The intervention of grief counseling will be held according to the protocol by trained mental health experts, individually and in person at the health center.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr. Noushin Khademoreza
Street address
Pour-sina St.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 4208
Email
admin@tums.ac.ir

2

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr. Noushin Khademoreza
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir

3

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Mr. Ali Asadi
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir

4

Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Mr. Ali Asadi
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
admin@kmu.ac.ir

5

Recruitment center
Name of recruitment center
Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr. Morteza Naserbakht
Street address
Golestan Freeway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir

6

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Morteza Naserbakht
Street address
University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Email
admin@tbzmed.ac.ir

7

Recruitment center
Name of recruitment center
Golestan University of Medical Sciences
Full name of responsible person
Dr. Marjan Fathi
Street address
Hircan Blv.
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir

8

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Marjan Fathi
Street address
Shahid Fakouri Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir

9

Recruitment center
Name of recruitment center
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mahdiyeh Salehi
Street address
Namjoo St.
City
Rasht
Province
Guilan
Postal code
4193833697
Phone
+98 13 3332 6061
Email
admin@gums.ac.ir

10

Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Dr. Mahdiyeh Salehi
Street address
A'lam-Al-Hoda St.
City
Arak
Province
Markazi
Postal code
38196693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motevalian
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Noushin Khademoreza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Mansouri st, Niyayesh st, Sattarkhan Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Email
nooshinkreza@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Noushin Khademoreza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Mansouri st, Niyayesh st, Sattarkhan Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Email
nooshinkreza@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Noushin Khademoreza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Mansouri st, Niyayesh st, Sattarkhan Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6650 6862
Email
nooshinkreza@gmail.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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