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Investigating the effectiveness of the intervention of Narrative Experiences Online using both qualitative and quantitative methods in people with Attenuated Psychosis Syndrome

Protocol summary

Study aim
Investigating the effectiveness of the intervention of Narrative Experiences Online in people with Attenuated Psychosis Syndrome
Design
The present study includes an experimental group and a control group, and the intervention of online narrative experiences is implemented for the experimental group. The control group received no intervention. The number of participants in each group is 15 people, who are replaced randomly in two experimental and control groups after purposeful sampling. In this study, there is no blinding, and at the end of the intervention (52 weeks), the data will be analysis in two quantitative (Mancova) and qualitative (Narrative – Reflective thematic) methods.
Settings and conduct
The place of sample selection, obtaining informed consent, completing the questionnaire, conducting interviews and recording the narratives is the Psychiatry and Psychology Clinic in Taleghani Hospital, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: including age over 18 years, non-diagnosis of schizotypal disorder, mood disorders, substance use disorder, learning disabilities and intellectual disabilities, as well as language disorders. exclusion criteria: subjects withdraw from participating in the research process.
Intervention groups
In the Narrative Experiences Online intervention, stories from people with similar lived experiences are collected and made available to subjects to see, hear and read in the NEON intervention. This intervention lasts 52 weeks and the change model underlying it is basically Transdiagnostic. Also, in this study, the control group does not receive treatment, and only after the intervention of the experimental group, the use of treatment sessions is suggested to the control group.
Main outcome variables
Lived experiences

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230405057823N2
Registration date: 2023-10-13, 1402/07/21
Registration timing: prospective

Last update: 2023-10-13, 1402/07/21
Update count: 0
Registration date
2023-10-13, 1402/07/21
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
2023-12-22, 1402/10/01
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 the intervention of Narrative Experiences Online using both qualitative and quantitative methods in people with Attenuated Psychosis Syndrome
Public title
Investigating the effectiveness of the intervention of Narrative Experiences Online in people with Attenuated Psychosis Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. No diagnose Schizotypal personality disorder 2. No history of Schizophrenia and mood disorders 3. No history of taking Antipsychotic drugs 4. No drug abuse 5. No diagnose severe learning and mental disabilities and medical or neurological diseases that cause psychotic symptoms
Exclusion criteria:
1.Diagnosis of psychotic spectrum disorders 2. Age below 18 years 3. Diagnosis of mood disorders 4. Lack of informed consent
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 by targeted sampling in qualitative studies, we will then randomly assign people to two groups of experimental and control. To do this, we give the subjects number 1 to 30 and after we put them in a container, we remove two numbers each time and one in the experimental group and one in the group We put control. As such, the subjects of both groups are selected. In this study, there is no blind maker, and after the intervention, the control groups of the control group use several treatment sessions.
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
Faculty of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Street, Shahid Beheshti University of Medical Sciences, Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.SBMU.MSP.REC.1401. 699

Health conditions studied

1

Description of health condition studied
Attenuated Psychosis Syndrome
ICD-10 code
F23
ICD-10 code description
Brief psychotic disorder

Primary outcomes

1

Description
Lived experiences
Timepoint
Pre-test and Post-test
Method of measurement
Semi-structured interview, unstructured interview and picture cards

Secondary outcomes

1

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

2

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

3

Description
Prodromal symptoms
Timepoint
Pre-test and Post-test
Method of measurement
Prodromal symptoms questionnaire and semi-structured interview

4

Description
Psychotic attachment
Timepoint
Pre-test and Post-test
Method of measurement
Psychotic attachment questionnaire

Intervention groups

1

Description
Intervention group: Narrative Experiences Online The NEON programme evaluates whether having online access to people’s real-life stories of recovery from mental health problems can be helpful for people affected by mental health problems. The NEON Intervention is deliver through a webapplication to its users. The NEON Intervention Foundation is a recommender system that matches users with narratives deemed beneficial to them.In NEON we are using recovery stories which are first-person lived experience accounts, include elements of both adversity/struggle and of strength/success/survival related at least in part to mental health problems (i.e. is about recovery). This intervention lasts 52 weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital, Tehran
Full name of responsible person
Maryam Amini Faskhoudi
Street address
Golestan town, Gol Azin St., East Diba Alley, No. 1
City
Tehran
Province
Tehran
Postal code
1493946761
Phone
+98 21 4470 2905
Email
amini.maryam329@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
Vu-Execut@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Amini Faskhoudi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Gol Azin Street, Diba Alley, 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 Faskhoudi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Gol Azin Street, Diba Alley, 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 Faskhudi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Gol Azin Street, Diba Alley, 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)
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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