Protocol summary
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Study aim
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Effectiveness of Narrative experiences online intervention in patients with first episode of psychosis using two methods of qualitative and quantitative data analysis
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Design
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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.
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Settings and conduct
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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. Narratives are conducted with the help of semi-structured and unstructured interviews, picture cards and questionnaires.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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).
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Main outcome variables
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Narratives of patients with the first episode of psychosis
General information
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Reason for update
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Modification of the intervention title
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Acronym
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NEON
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IRCT registration information
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IRCT registration number:
IRCT20230405057823N1
Registration date:
2023-07-30, 1402/05/08
Registration timing:
registered_while_recruiting
Last update:
2023-09-26, 1402/07/04
Update count:
4
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Registration date
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2023-07-30, 1402/05/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-07-23, 1402/05/01
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Expected recruitment end date
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2024-06-19, 1403/03/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effectiveness of Narrative experiences online intervention using both qualitative and quantitative methods in patients with first episode of psychosis
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Public title
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Investigating the effectiveness of Narrative experiences online intervention in patients with first episode of psychosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Making a treatment application based on the defined algorithm
Ethics committees
1
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Ethics committee
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Approval date
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2023-03-11, 1401/12/20
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Ethics committee reference number
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IR.SBMU.MSP.REC.1401.699
Health conditions studied
1
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Description of health condition studied
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Schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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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
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Description
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Lived experiences
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Timepoint
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Before the start of the intervention and the end of the intervention (qualitative part)
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Method of measurement
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Semi-structured interview, unstructured interview and picture cards
Secondary outcomes
1
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Description
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Mental health trust scale
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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Questionnaire
2
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Description
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Quality of Life
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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Questionnaire
3
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Description
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Hope
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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Questionnaire
4
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Description
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Psychotic attachment
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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Questionnaire
5
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Description
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Personal recovery
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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Questionnaire
6
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Description
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Life events
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Timepoint
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Week 1, 12 and 52 (quantitative part)
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: no treatment
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shahid Beheshti University of Medical Sciences-100 million toman sponsorship of product-oriented theses
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Proportion provided by this source
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25
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The publication program is related to the printing of the article
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When the data will become available and for how long
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2 years
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To whom data/document is available
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Only the researchers of the present study
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Under which criteria data/document could be used
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Analysis and interpretation
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From where data/document is obtainable
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Principal investigator
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What processes are involved for a request to access data/document
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Research researchers are in contact with each other
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Comments
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