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

    The place of collection of patients' narratives is Razi Hospital in Tehran, and their registration and storage is done in compliance with ethical principles and obtaining informed consent by completing the form in writing. The data are analyzed both qualitatively and quantitatively (reflective- thematic narrative 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 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.
    محل جمع آوری روایات بیماران، بیمارستان رازی 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. 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.
  • General information

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    عدم بارگذاری متن ویرایش شده
    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 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
  • Intervention groups

    #1
    گروه آزمایش: دریافت مداخله تجربیات روایتی آنلاین مداخله تجارب روایتی آنلاین یک مطالعه تحقیقاتی در مقیاس بزرگ است که از 2017 تا 2023 اجرا می‌شود و به دنبال جذب شرکت‌کنندگانی است که کاربران فعلی هر گونه خدمات سلامت روان و کارکنان بهداشت روان هستند تا به طراحی و آزمایش یک مداخله بالینی که بر اساس روایت‌های بهبودی ساخته شده است، کمک کند. تیم مطالعه داستان‌هایی را از طیف گسترده‌ای از منابع جمع‌آوری می‌کند، با تمرکز بر داستان‌هایی از افرادی که صدایشان به ندرت توسط فرهنگ‌های رایج شنیده می‌شود و آنها را گرد هم می‌آورد تا بزرگترین مخزن آنلاین داستان‌های بهبودی (Recovery) سلامت روان در جهان را تشکیل دهد. آنها سپس این داستان¬ها را در دسترس دیگران قرار می¬دهند تا در مداخله neon ببینند، بشنوند و بخوانند و در یک کارآزمایی تصادفی کنترل شده ارزیابی کنند که آیا افراد از مداخله نئون سود می¬برند یا خیر؟ آنها همچنین بررسی خواهند کرد که آیا دسترسی به این داستان ها می¬تواند نحوه حمایت کارکنان بهداشت روان از افراد مبتلا به روان پریشی را بهبود بخشد؟ ارزیابی در هفته¬های 1، 12 و 52 برای تجزیه و تحلیل بالینی مورد نیاز است. همچنین، به ارزیابی پیگیری در هفته 104 نیاز نیست؛ زیرا نتایج در پایان مداخله مجددا علاوه بر تحلیل کمی، مورد تحلیل کیفی قرار می¬گیرند.
    گروه آزمایش: دریافت مداخله تجربیات روایتی آنلاین مداخله تجارب روایتی آنلاین یک مطالعه تحقیقاتی در مقیاس بزرگ است که از 2017 تا 2023 اجرا می‌شود و به دنبال جذب شرکت‌کنندگانی است که کاربران فعلی هر گونه خدمات سلامت روان و کارکنان بهداشت روان هستند تا به طراحی و آزمایش یک مداخله بالینی که بر اساس روایت‌های بهبودی ساخته شده است، کمک کند. تیم مطالعه داستان‌هایی را از طیف گسترده‌ای از منابع جمع‌آوری می‌کند، با تمرکز بر داستان‌هایی از افرادی که صدایشان به ندرت توسط فرهنگ‌های رایج شنیده می‌شود و آنها را گرد هم می‌آورد تا بزرگترین مخزن آنلاین داستان‌های بهبودی سلامت روان در جهان را تشکیل دهد. آنها سپس این داستانها را در دسترس دیگران قرار میدهند تا در مداخله neon ببینند، بشنوند و بخوانند و در یک کارآزمایی تصادفی کنترل شده ارزیابی کنند که آیا افراد از مداخله نئون سود میبرند یا خیر؟ آنها همچنین بررسی خواهند کرد که آیا دسترسی به این داستان ها میتواند نحوه حمایت کارکنان بهداشت روان از افراد مبتلا به روان پریشی را بهبود بخشد؟ ارزیابی در هفته های 1، 12 و 52 برای تجزیه و تحلیل بالینی مورد نیاز است. همچنین، به ارزیابی پیگیری در هفته 104 نیاز نیست؛ زیرا نتایج در پایان مداخله مجددا علاوه بر تحلیل کمی، مورد تحلیل کیفی قرار میگیرند
  • Recruitment centers

    #1
    Name of recruitment center - English: Razi psychiatric hospital
    Name of recruitment center - Persian: مرکز روانپزشکی رازی
    Full name of responsible person - English: maryam amini fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Taghi Abad Road - Shahid Rostgar Blvd - Razi Psychiatry Training and Treatment Center
    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: Roozbeh Psychiatric Hospital
    Name of recruitment center - Persian: بیمارستان روان پزشکی روزبه
    Full name of responsible person - English: Maryam Amini Fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: South Kargar St., below Lashgar intersection
    Street address - Persian: خیابان کارگر جنوبی، پایین‌تر از چهارراه لشگر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 13337159140
    Phone: +98 21 5541 9151
    Fax:
    Email: hosp_roozbeh@tums.ac.ir
    Web page address:
    #3
    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:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: maryam amini fasakhoudi
    Full name of responsible person - Persian: مریم امینی فسخودی
    Street address - English: Valenjak, Student Blvd., Arabi St., Shahid Beheshti University of Medical Sciences
    Street address - Persian: تهران، ولنجک، بلوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 23871
    Fax:
    Email: info@sbmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Afshin Zarghi
    Full name of responsible person - Persian: افشین زرقی
    Street address - English: Vice President of Research and Technology, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Arabi Street, Chamran Highway
    Street address - Persian: بزرگراه چمران، خیابان اعرابی، جنب بیمارستان طالقانی، دانشگاه علوم پزشکی شهید بهشتی، معاونت تحقیقات و فناوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 23871
    Fax:
    Email: info@sbmu.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
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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..
Intervention groups
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.
Main outcome variables
Narratives of patients with first episode of psychosis and reduced psychosis syndrome

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: 2023-08-01, 1402/05/10
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
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
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)
Single blinded
Blinding description
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.
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
Shahid Shahriari Square, Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences, Building No. 2, Second Floor, Tehran PO Box: 19395-4631. Phone: 021-42439872
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

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
Kilometer 7 of Karaj special road, next to Azadegan North entrance, behind Shahid Tandgovian parking lot
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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