Protocol summary
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Study aim
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Determining the effectiveness of educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital in Mashhad
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Design
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Clinical trial with control group, blocked, on 54 patients
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Settings and conduct
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After reviewing the inclusion criteria, the primary caregivers of individuals with any psychiatric disorder (schizophrenia, bipolar disorder, and major depression) are randomly assigned to the intervention or control group. Then, three sessions of mental health literacy training will be conducted by the psychiatric assistant and under the supervision of psychiatric professors in groups (in groups of 10 to 15 people).
In this study, the results evaluator as well as the analyzer are blinded about the type of class held for each group.
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Participants/Inclusion and exclusion criteria
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Inclusin Criteria:
Be a primary caregiver of the patient for at least 6 months, Does not have acute symptoms of psychiatric, disorders, The patient (hospitalized) meets the DSM-5 criteria for schizophrenia, bipolar disorder, or major depression and should not have substance use disorders other than nicotine, Ability to read and write, Signing informed consent form to participate in the study
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Intervention groups
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Caregivers of psychiatric patients admitted to Ibn Sina Hospital in Mashhad
For those entering the intervention group, classes to increase the level of mental health literacy and for those entering the control group, life skills classes are given.
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Main outcome variables
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Mental health literacy
General information
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Reason for update
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Completion and revision of inclusion criteria and blinding
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211227053550N1
Registration date:
2022-03-08, 1400/12/17
Registration timing:
registered_while_recruiting
Last update:
2026-04-27, 1405/02/07
Update count:
1
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Registration date
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2022-03-08, 1400/12/17
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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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2022-01-03, 1400/10/13
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Expected recruitment end date
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2023-03-04, 1401/12/13
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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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Evaluation of the effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital
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Public title
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The effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Be a primary caregiver of the patient for at least 6 months
Without any acute symptoms of psychiatric disorders
Ability to read and write
Age between 18-60
The patient (hospitalized) meets the DSM-5 criteria for schizophrenia, bipolar disorder, or major depression and should not have substance use disorders other than nicotine
Having informed consent to participate in the study
Exclusion criteria:
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Age
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From 18 years old to 60 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:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible individuals will enter the study after obtaining informed consent (purpose-based sampling).Individuals randomly (random allocation using dedicated randomization sites such as sealed envelop) into two groups of intervention (three 90-minute group sessions of mental health literacy training at one-week intervals) and control (three 90-minute group sessions with skill training content Of life) will be divided.It should be noted that randomization will be done in blocks using 4 or 6 blocks.After random assignment, the type of group assigned to each person (for example, even and odd numbers) will be written on a sheet of paper, and each sheet will be placed in an envelope in the package.After informing the individuals, if the person (health care provider) is eligible to enter the study, he / she will be asked to complete the informed consent form.Then an envelope will be picked (allocation concealment) and the names and surnames of the people and their contact numbers will be written on it for further coordination and according to the code written in the envelope, the people are placed in one of the two intervention or control groups.
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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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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-07, 1400/09/16
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1400.620
Health conditions studied
1
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Description of health condition studied
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Health literacy of caregivers of psychiatric patients
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Health literacy of caregivers of psychiatric patients
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Timepoint
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Before the classes, at the end of the third session and two months after the end of the sessions, the participants will complete the mental health literacy scale.
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Method of measurement
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"Mental Health Literacy Scale"The questionnaire was developed by O'Connor et al. And consists of 35 questions and 6 attributes. These 6 attributes are: 1.Ability to diagnose disorders: It includes 8 questions that are scored using a 4-point Likert scale (very unlikely, unlikely, probable, very probable). 2.Knowledge of risk factors and causes: consists of 2 questions that are scored using a 4-point Likert scale (very unlikely, unlikely, probable, very probable). 3.Knowledge about self-medication: consists of 2 questions that are scored using a 4-point Likert scale (very unhelpful, unhelpful, beneficial, very beneficial). 4.Knowledge of available professional help: consists of 3 questions that are graded using a 4-point Likert scale (very unlikely, unlikely, probable, very probable). 5.Knowledge of where to look for information: Contains 4 questions that are scored using a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree). 6.Attitudes about promoting appropriate diagnosis or supportive behavior: includes 16 questions using a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) or (definitely willing, probably willing, Neither reluctant nor reluctant, probably reluctant, definitely reluctant) are scored.
Intervention groups
1
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Description
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Intervention group: For caregivers of people with psychiatric diseases, three sessions of mental health literacy training will be conducted by a psychiatric assistant and under the supervision of psychiatric professors in groups (in groups of 10 to 15 people). Each session lasts 90 minutes. Meetings will be held interactively with questions and answers. The content of the sessions is as follows: The first session (project introduction) Explaining the rules of participation in group meetings (timely attendance at meetings and the need to participate in both sessions), reviewing participants' knowledge about the concept of mental health, mental illness and causes of disorders Mental, explaining the concept of mental health, mental illness and its causes and correcting participants 'opinions, examining participants' knowledge about the symptoms of psychiatric disorders and their diagnosis, explaining the signs and symptoms of common and important psychiatric disorders (anxiety, mood, Psychotic). Session 2: Reviewing the topics of the previous session, reviewing people's opinions about the treatment of mental disorders and seeking professional help, explaining about the treatment of mental disorders (medication and psychotherapy), explaining the consequences of not treating mental disorders and the need for help Professional, reviewing individuals' knowledge of how to access and explaining mental health professional assistance. Session 3: Reviewing the topics of the previous session, examining people's opinions about the mentally ill (including their risk, their social and interpersonal skills, and the treatability of the disorder), explaining the stigma of mental disorders, and correcting participants' opinions through Group discussion, summary. At the end of the third session and two months after the end of the sessions, the participants will complete the Mental Health Literacy Scale again.
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Category
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Lifestyle
2
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Description
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Control group: کلاس مهارت های زندگی
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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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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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