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Investigating the effectiveness of online narrative intervention using both qualitative and quantitative methods in patients with first episode of psychosis

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History
# Registration date Revision Id
5 2023-09-03, 1402/06/12 280077
4 2023-08-08, 1402/05/17 274612
3 2023-08-01, 1402/05/10 274154
2 2023-07-31, 1402/05/09 273681
1 2023-07-30, 1402/05/08 273485
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  • Protocol summary

    This study includes two experimental groups and two control groups, which are selected from patients with the first episode of schizophrenia and people diagnosed with Attenuated psychosis based on random replacement. The sample in each group consists of 30 people and the initial differences between the subjects are analyzed by the method of control covariance analysis and Mancova statistical method.
    The current study includes an experimental group and a control group, which are selected by random replacement. The sample in each group consists of 15 people, and the initial differences between the subjects are analyzed by the statistical methods of covariance analysis, control, and then with two quantitative (Mancova) and qualitative (thematic/reflective-narrative) methods.
    این مطالعه شامل دو گروه آزمایش و دو گروه کنترل است که از میان بیماران با اولین دوره اسکیزوفرنی و افراد با تشخیص سندرم سایکوز خفیف بر اساس جایگزینی تصادفی انتخاب می شوند. نمونه در هر گروه شامل 30 نفر می باشد و تفاوت های اولیه میان آزمودنی ها به روش تحلیل کووراریانس کنترل و با روش آماری مانکووآ تحلیل می شوند.
    مطالعه حاضر شامل یک گروه آزمایش و یک گروه کنترل است که به شیوه جایگزینی تصادفی انتخاب می شوند. نمونه در هر گروه شامل 15 نفر می باشد و تفاوت های اولیه میان آزمودنی ها به روش های آماری تحلیل کووراریانس، کنترل و سپس با دو روش کمی (مانکووآ) و کیفی (موضوعی/انعکاسی - روایتی) تحلیل می شوند.
    The place of collecting patients' narratives is Razi Psychiatric Hospital, Rozbeh, Tehran, Iran, and their registration and storage is done in accordance with ethical principles and obtaining informed consent by completing the form in writing. The data are analyzed both qualitatively and quantitatively (reflective-narrative thematic analysis method and Mankova statistical method). The method of collecting narratives is done with the help of semi-structured and unstructured interviews and questionnaires.
    The place of collecting patients' narratives is Razi, Rouzbeh and Iran Psychiatric Hospital in Tehran, and their registration and storage is also done in compliance with ethical principles and obtaining informed consent by completing the form in writing. The method of collecting narratives is done with the help of semi-structured and unstructured interviews and questionnaires.
    محل جمع آوری روایات بیماران، بیمارستان روان پزشکی رازی، روزبه و ایران در تهران می باشد و ثبت و نگهداری آنها نیز با رعایت اصول اخلاقی و اخذ رضایت آگاهانه با تکمیل فرم به صورت کتبی انجام می شود. داده ها به دو صورت کیفی و کمی (روش تحلیل موضوعی انعکاسی - روایتی و روش آماری مانکووا) تجزیه و تحلیل می شوند. روش گردآوری روایات به کمک مصاحبه نیمه ساختاریافته و ساختار نایافته و پرسشنامه انجام می شود.
    محل جمع آوری روایات بیماران، بیمارستان روان پزشکی رازی، روزبه و ایران در تهران می باشد و ثبت و نگهداری آنها نیز با رعایت اصول اخلاقی و اخذ رضایت آگاهانه با تکمیل فرم به صورت کتبی انجام می شود. روش گردآوری روایات به کمک مصاحبه نیمه ساختاریافته و ساختار نایافته و پرسشنامه انجام می شود.
    The selection of the sample is done based on the DSM-5 structured clinical interview, completion of questionnaires and demographic information by the main researcher..
    he selection of the sample is done based on the entry and exit criteria by conducting a clinical interview, completing questionnaires and demographic information by the main researcher.
    انتخاب نمونه بر اساس انجام مصاحبه بالینی ساختار یافته دی اس ام فایو، تکمیل پرسشنامه ها و اطلاعات دموگرافیک توسط محقق اصلی انجام می شود.
    انتخاب نمونه بر اساس ملاک های ورود و خروج با انجام مصاحبه بالینی، تکمیل پرسشنامه ها و اطلاعات دموگرافیک توسط محقق اصلی انجام می شود.
    The intervention consists of a password-controlled online link that presents narratives of mental health recovery. In the present study, the narratives are obtained through interviews with schizophrenic patients in the phase of symptom subsidence. First, the recorded narratives of recovered patients are selected by the feature list of recovery stories, and after the approval of the ethics committee, they are made available online to the experimental groups.
    The experimental group intervention consisted of a password-controlled online link that presented narratives of mental health recovery. In the present study, narratives are obtained through interviews with schizophrenia patients in the remission phase. First, these recorded narratives are selected by the recovery story feature list tool, and after ethics committee approval, they are made available online to the experimental groups. Also, access to the main intervention is provided for the control group after the end of the treatment phase. In fact, patients in the control group will receive the usual treatment (drug therapy).
    مداخله شامل یک لینک آنلاین کنترل شده با رمز عبور است که روایت‌های بهبودی سلامت روان را ارایه می‌دهد. در مطالعه حاضر، روایت‌ها از طریق مصاحبه با بیماران اسکیزوفرنی در مرحله فروکش علایم به دست می‌آید. ابتدا روایت‌های ضبط شده بیماران بهبود یافته توسط فهرست ویژگی‌های داستان‌های بهبودی، انتخاب و پس از تایید کمیته اخلاق آنلاین می‌شوند تا در دسترس گروه‌های آزمایشی قرار گیرند.
    مداخله گروه آزمایش شامل یک لینک آنلاین کنترل شده با رمز عبور است که روایت‌های بهبودی سلامت روان را ارایه می‌دهد. در مطالعه حاضر، روایت‌ها از طریق مصاحبه با بیماران اسکیزوفرنی در مرحله فروکش به دست می‌آید. ابتدا این روایت‌های ضبط شده توسط ابزار فهرست ویژگی‌های داستان‌های بهبودی، انتخاب و پس از تایید کمیته اخلاق آنلاین می‌شوند تا در دسترس گروه‌های آزمایشی قرار گیرند. همچنین، برای گروه کنترل پس از خاتمه فاز درمان، دسترسی به مداخله اصلی فراهم می شود. در واقع، بیماران در گروه کنترل درمان معمول (دارو درمانی) را دریافت خواهند کرد.
    Narratives of patients with first episode of psychosis and reduced psychosis syndrome
    Narratives of patients with the first episode of psychosis
    روایت های بیماران با اولین دوره سایکوز و نیز سندرم سایکوز تخفیف یافته
    روایت های بیماران با اولین دوره روان پریشی

  • General information

    Single blinded
    Not blinded
    1
    These patients must be in their first episode of psychosis and have not experienced or reported any history of diagnosis and treatment of schizophrenia in the past.
    No history of mood disorders
    No history of taking Antipsychotic drugs
    No drug abuse
    Failure to diagnose severe learning and mental disabilities and medical or neurological diseases that cause symptoms of psychosis.
    The criteria for entering the sample with the first episode of schizophrenia are: meeting the conditions based on the criteria of DSM-5-TR and the duration of the diagnosis period of at least 6 months
    These patients must be in their first episode of psychosis and have not experienced or reported any history of diagnosis and treatment of schizophrenia in the past.
    No history of mood disorders
    No history of taking Antipsychotic drugs
    No drug abuse
    Failure to diagnose severe learning and mental disabilities and medical or neurological diseases that cause symptoms of psychosis.
    The criteria for entering the sample with the first episode of schizophrenia are: meeting the conditions based on the criteria of DSM-5-TR and the duration of the diagnosis period of at least 6 months
    Failure to diagnose mental disability or dementia, acute symptoms of psychosis and severe restlessness, communication and language problems that prevent interviews.
    این بیماران باید در اولین دوره روان پریشی خود باشند و در گذشته هیچ سابقه‌ای از تشخیص و درمان اسکیزوفرنی را تجربه و گزارش نکرده باشند.
    عدم سابقه اختلالات خلقی
    عدم سابقه مصرف داروهای آنتی سایکوتیک
    عدم سوء مصرف مواد و دارو
    عدم تشخیص ناتوانیهای شدید یادگیری و ذهنی و بیماریهای پزشکی و یا عصب شناختی ایجادکننده علایم سایکوز.
    معیارهای ورود در نمونه با اولین دوره اختلال اسکیزوفرنی عبارتند از: احراز شرایط بر اساس ملاک‌های DSM-5-TR و طول دوره حداقل 6 ماه تشخیص
    این بیماران باید در اولین دوره روان پریشی خود باشند و در گذشته هیچ سابقه‌ای از تشخیص و درمان اسکیزوفرنی را تجربه و گزارش نکرده باشند.
    عدم سابقه اختلالات خلقی
    عدم سابقه مصرف داروهای آنتی سایکوتیک
    عدم سوء مصرف مواد و دارو
    عدم تشخیص ناتوانی های شدید یادگیری و ذهنی و بیماریهای پزشکی و یا عصب شناختی ایجادکننده علایم سایکوز.
    معیارهای ورود در نمونه با اولین دوره اختلال اسکیزوفرنی عبارتند از: احراز شرایط بر اساس ملاک‌های DSM-5-TR و طول دوره حداقل 6 ماه تشخیص
    عدم تشخیص ناتوانی ذهنی و یا زوال عقل، علایم حاد روان پریشی و بی قراری شدید، مشکلات ارتباطی و زبان که مانع از انجام مصاحبه ها شود.
    Lack of access or support to access the Internet through a personal computer or mobile device
    Individuals who were experiencing a crisis or who were otherwise unable to participate in the research were excluded.
    Lack of access or support to access the Internet through a personal computer or mobile device
    People experiencing crisis cannot participate in research.
    عدم دسترسی یا پشتیبانی برای دسترسی به اینترنت از طریق رایانه شخصی و یا دستگاه تلفن همراه
    فرادی که بحران را تجربه می کردند یا نمی توانستند در تحقیق شرکت کنند از مطالعه خارج شدند.
    عدم دسترسی یا پشتیبانی برای دسترسی به اینترنت از طریق رایانه شخصی و یا دستگاه تلفن همراه
    افرادی که بحران را تجربه می کنند نمی توانند در تحقیق شرکت کنند.
    In our study, the intervention is done in a blind way for the subjects. Then, at the end of the intervention, the subjects of the control group are suggested to use several treatment sessions.
    در مطالعه ما برای آزمودنی ها مداخله به صورت یک سو کور انجام می شود. سپس، در پایان مداخله به آزمودنی های گروه کنترل استفاده از چندین جلسه درمان پیشنهاد می شود.

  • Secondary outcomes

    #1
    empty
    Life events
    empty
    رویدادهای زندگی
    empty
    Week 1, 12 and 52 (quantitative part)
    empty
    هفته 1، 12 و 52 (بخش کمی)
    empty
    questionnaire
    empty
    پرسشنامه

  • Recruitment centers

    #1
    Name of recruitment center - English: Razi Psychiatric Hospital
    Name of recruitment center - Persian: بیمارستان روانپزشکی رازی
    Full name of responsible person - English: Maryam Amini Fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Razi Psychiatry Training Center, Shahid Rostgar Blvd., Taghi Abad Road, Shahreri
    Street address - Persian: سه راه تقی آباد - بلوار شهید رستگار - مرکز آموزشی و درمانی روانپزشکی رازی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1867612016
    Phone: +98 21 3340 1220
    Fax:
    Email: razi@uswr.ac.ir
    Web page address:
    Name of recruitment center - English: Razi Psychiatric Hospital
    Name of recruitment center - Persian: بیمارستان روانپزشکی رازی
    Full name of responsible person - English: Maryam Amini Fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Razi Psychiatry Training Center, Shahid Rostgar Blvd., Taghi Abad Road, Shahreri
    Street address - Persian: سه راه تقی آباد، بلوار شهید رستگار، مرکز آموزشی و درمانی روانپزشکی رازی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1867612016
    Phone: +98 21 3340 1220
    Fax:
    Email: razi@uswr.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Iran Psychiatric Hospital
    Name of recruitment center - Persian: بیمارستان روان پزشکی ایران
    Full name of responsible person - English: Maryam Amini Fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Kilometer 7 of Karaj special road, next to Azadegan North entrance, behind Shahid Tandgovian parking lot
    Street address - Persian: کیلومتر 7 جاده مخصوص کرج ، جنب ورودی آزادگان شمال ، پشت پارکینگ شهید تندگویان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1398913151
    Phone: +98 21 4450 3399
    Fax:
    Email: iph@iums.ac.ir
    Web page address:
    Name of recruitment center - English: Iran Psychiatric Hospital
    Name of recruitment center - Persian: بیمارستان روان پزشکی ایران
    Full name of responsible person - English: Maryam Amini Fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Behind Shahid Tondgoyian parking lot, next to Azadegan North entrance, Kilometer 7 of Karaj special road
    Street address - Persian: کیلومتر 7 جاده مخصوص کرج، جنب ورودی آزادگان شمال، پشت پارکینگ شهید تندگویان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1398913151
    Phone: +98 21 4450 3399
    Fax:
    Email: iph@iums.ac.ir
    Web page address:

Protocol summary

Study aim
The effectiveness of the intervention of online narrative experiences in the two study groups using qualitative and quantitative data analysis methods
Design
The current study includes an experimental group and a control group, which are selected by random replacement. The sample in each group consists of 15 people, and the initial differences between the subjects are analyzed by the statistical methods of covariance analysis, control, and then with two quantitative (Mancova) and qualitative (thematic/reflective-narrative) methods.
Settings and conduct
The place of collecting patients' narratives is Razi, Rouzbeh and Iran Psychiatric Hospital in Tehran, and their registration and storage is also done in compliance with ethical principles and obtaining informed consent by completing the form in writing. The method of collecting narratives is done with the help of semi-structured and unstructured interviews and questionnaires.
Participants/Inclusion and exclusion criteria
he selection of the sample is done based on the entry and exit criteria by conducting a clinical interview, completing questionnaires and demographic information by the main researcher.
Intervention groups
The experimental group intervention consisted of a password-controlled online link that presented narratives of mental health recovery. In the present study, narratives are obtained through interviews with schizophrenia patients in the remission phase. First, these recorded narratives are selected by the recovery story feature list tool, and after ethics committee approval, they are made available online to the experimental groups. Also, access to the main intervention is provided for the control group after the end of the treatment phase. In fact, patients in the control group will receive the usual treatment (drug therapy).
Main outcome variables
Narratives of patients with the first episode of psychosis

General information

Reason for update
Not loading the edited text
Acronym
NEON
IRCT registration information
IRCT registration number: IRCT20230405057823N1
Registration date: 2023-07-30, 1402/05/08
Registration timing: registered_while_recruiting

Last update: 2023-08-06, 1402/05/15
Update count: 4
Registration date
2023-07-30, 1402/05/08
Registrant information
Name
maryam amini fasakhoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4470 2905
Email address
amini.maryam329@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of online narrative intervention using both qualitative and quantitative methods in patients with first episode of psychosis
Public title
Investigating the effectiveness of online narrative intervention using both qualitative and quantitative methods in patients with first episode of psychosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
These patients must be in their first episode of psychosis and have not experienced or reported any history of diagnosis and treatment of schizophrenia in the past. No history of mood disorders No history of taking Antipsychotic drugs No drug abuse Failure to diagnose severe learning and mental disabilities and medical or neurological diseases that cause symptoms of psychosis. The criteria for entering the sample with the first episode of schizophrenia are: meeting the conditions based on the criteria of DSM-5-TR and the duration of the diagnosis period of at least 6 months Failure to diagnose mental disability or dementia, acute symptoms of psychosis and severe restlessness, communication and language problems that prevent interviews.
Exclusion criteria:
Lack of access or support to access the Internet through a personal computer or mobile device People experiencing crisis cannot participate in research.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, after selecting the subjects using the purposeful sampling method in qualitative studies, in the next step, we assign the people to two experimental and control groups using the random number table method from numbers 1 to 30. Also, the subjects will not know about the implementation of the intervention and its process until the end of the treatment and it is done in a blind way. After the end of the intervention, the subjects of the control group are suggested to use several treatment sessions.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Making a treatment application based on the defined algorithm

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti of Medical Sciences
Street address
Second Floor, Building No. 2, Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Student Blvd, Shahriari Square, velenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1401.699

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although

Primary outcomes

1

Description
Lived experiences
Timepoint
Before the start of the intervention and the end of the intervention (qualitative part)
Method of measurement
Semi-structured and unstructured interview

Secondary outcomes

1

Description
Mental health trust scale
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
Questionnaire

2

Description
Quality of Life
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
Questionnaire

3

Description
Hope
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
Questionnaire

4

Description
Psychotic attachment
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
Questionnaire

5

Description
Personal recovery
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
Questionnaire

6

Description
Life events
Timepoint
Week 1, 12 and 52 (quantitative part)
Method of measurement
questionnaire

Intervention groups

1

Description
Experimental group: receiving the intervention of online narrative experiences The Online Narrative Experiences Intervention is a large-scale research study running from 2017 to 2023 that seeks to recruit participants who are current users of any mental health service and mental health workers to design and test a clinical intervention based on recovery narratives. Made to help. The study team collects stories from a wide range of sources, focusing on the stories of people whose voices are rarely heard by mainstream culture, and brings them together to form the world's largest online repository of mental health recovery stories. They then make these stories available to others to see, hear and read about the NEON intervention and evaluate in a randomized controlled trial whether people benefit from the neon intervention or not. They will also investigate whether access to these stories can improve the way mental health workers support people with Psychosis. Assessments at weeks 1, 12, and 52 are required for clinical analysis. Also, follow-up assessment at 104 weeks is not required; Because at the end of the intervention, the results are subjected to qualitative analysis in addition to quantitative analysis.
Category
Rehabilitation

2

Description
Control group: no treatment
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Maryam Amini Fasakhoudi
Street address
Razi Psychiatry Training Center, Shahid Rostgar Blvd., Taghi Abad Road, Shahreri
City
Tehran
Province
Tehran
Postal code
1867612016
Phone
+98 21 3340 1220
Email
razi@uswr.ac.ir

2

Recruitment center
Name of recruitment center
Roozbeh Psychiatric Hospital
Full name of responsible person
Maryam Amini Fasakhoudi
Street address
South Kargar St., below Lashgar intersection
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
hosp_roozbeh@tums.ac.ir

3

Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Maryam Amini Fasakhoudi
Street address
Behind Shahid Tondgoyian parking lot, next to Azadegan North entrance, Kilometer 7 of Karaj special road
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3399
Email
iph@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice President of Research and Technology, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Arabi Street, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences-100 million toman sponsorship of product-oriented theses
Proportion provided by this source
25
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Amini Fasakhoudi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Dibashargi Alley, ,Gol Azin St.,Golestan town
City
Tehran
Province
Tehran
Postal code
1493946761
Phone
+98 21 4470 2905
Email
amini.maryam329@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Amini Fasakhoudi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Dibashargi Alley, Gol Azin St, Golestan town
City
Tehran
Province
Tehran
Postal code
1493946761
Phone
+98 21 4470 2905
Email
amini.maryam329@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Amini Fasakhoudi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1 , Dibashargi Alley,Gol Azin St.,Golestan town
City
Tehran
Province
Tehran
Postal code
1493946761
Phone
+98 21 4470 2905
Email
amini.maryam329@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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The publication program is related to the printing of the article
When the data will become available and for how long
2 years
To whom data/document is available
Only the researchers of the present study
Under which criteria data/document could be used
Analysis and interpretation
From where data/document is obtainable
Principal investigator
What processes are involved for a request to access data/document
Research researchers are in contact with each other
Comments
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