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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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History
# Registration date Revision Id
2 2026-04-27, 1405/02/07 375690
1 2022-03-08, 1400/12/17 219407
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  • Protocol summary

    Clinical trial with control group, double-blind, blocked, on 54 patients
    Clinical trial with control group, blocked, on 54 patients
    کارآزمایی بالینی دارای گروه کنترل، دو سویه کور، بلوک بندي شده، بر روی 54 نفر
    کارآزمایی بالینی دارای گروه کنترل، بلوک بندي شده، بر روی 54 نفر
    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 researcher analyzing the results are blinded about the type of class held for each group.
    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.
    پس از بررسی معیار های ورود، مراقبین اصلی افراد مبتلا به هر اختلال روانپزشکی (اسکیزوفرنی، دو قطبی و افسردگی اساسی) به صورت تصادفی در گروه مداخله یا کنترل قرار میگیرند. آموزش سواد سلامت روان توسط دستیار روانپزشکی انجام خواهد شد. سپس سه جلسه آموزش سواد سلامت روان توسط دستیار روانپزشکی و تحت نظارت اساتید روانپزشکی به صورت گروهی (در گروه های 10 تا 15 نفره) انجام خواهد شد و بعد از پایان جلسات و نیز دو ماه پس از اتمام جلسات، پرسشنامه مجددا توسط شرکت کنندگان تکیمل خواهند شد. در این مطالعه ارزیابی کننده نتایج و همچنین محقق تحلیل کننده نتایج، در مورد نوع کلاس برگزار شده برای هر گروه کورسازی شده اند.
    پس از بررسی معیار های ورود، مراقبین اصلی افراد مبتلا به هر اختلال روانپزشکی (اسکیزوفرنی، دو قطبی و افسردگی اساسی) به صورت تصادفی در گروه مداخله یا کنترل قرار میگیرند. آموزش سواد سلامت روان توسط دستیار روانپزشکی انجام خواهد شد. سپس سه جلسه آموزش سواد سلامت روان توسط دستیار روانپزشکی و تحت نظارت اساتید روانپزشکی به صورت گروهی (در گروه های 10 تا 15 نفره) انجام خواهد شد و بعد از پایان جلسات و نیز دو ماه پس از اتمام جلسات، پرسشنامه مجددا توسط شرکت کنندگان تکیمل خواهند شد. در این مطالعه ارزیابی کننده نتایج و همچنین تحلیل کننده نتایج، در مورد نوع کلاس برگزار شده برای هر گروه کورسازی شده اند.
    Be a primary family member of the patient, Be a patient's primary caregiver for at least 6 months, Does not have acute symptoms of major psychiatric, disorders that prevent effective participation in meetings, The patient (hospitalized) meets the DSM-5 criteria for schizophrenia, bipolar disorder, or major depression, The patient should not have substance use disorders other than nicotine, Level of education minimum cycle, Having informed consent to participate in the study
    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
    از اعضای درجه اول خانواده بیمار باشد. حداقل به مدت 6 ماه از مراقبین اصلی بیمار باشد. علائم حاد اختلالات ماژور روانپزشکی که مانع از شرکت مؤثر در جلسات میشود را نداشته باشد. بیمار (بستری در بیمارستان) بر اساس معیارهای DSM-5 مبتلا به اسکیزوفرنی، اختلال دوقطبی یا افسردگی اساسی باشد. بیمار مبتلا به اختلالات مصرف مواد به جز نیکوتین نباشد. سطح تحصیلات حداقل سیکل داشتن رضایت آگاهانه جهت شرکت در مطالعه
    شرایط ورود: حداقل به مدت 6 ماه مراقب اصلی بیمار باشد. علائم حاد اختلالات روانپزشکی را نداشته باشد. بیمار (بستری در بیمارستان) بر اساس معیارهای DSM-5 مبتلا به اسکیزوفرنی، اختلال دوقطبی یا افسردگی اساسی باشد و مبتلا به اختلالات مصرف مواد به جز نیکوتین نباشد. سواد خواندن و نوشتن داشتن رضایت آگاهانه جهت شرکت در مطالعه

  • General information

    Double blinded
    Not blinded
    1
    1
    empty
    Completion and revision of inclusion criteria and blinding
    empty
    اصلاح و تکمیل کرایتریای ورود و کورسازی
    Evaluation of the effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital
    The effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients
    Evaluation of the effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital
    اثربخشی برنامه آموزشی بر سواد سلامت روان مراقبین بیماران روانپزشکی
    Be a primary family member of the patient
    Be a patient's primary caregiver for at least 6 months
    Does not have acute symptoms of major psychiatric disorders that prevent effective participation in meetings
    The patient (hospitalized) meets the DSM-5 criteria for schizophrenia, bipolar disorder, or major depression
    The patient should not have substance use disorders other than nicotine
    Level of education minimum cycle
    Having informed consent to participate in the study
    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
    از اعضای درجه اول خانواده بیمار باشد. حداقل به مدت 6 ماه از مراقبین اصلی بیمار باشد. علائم حاد اختلالات ماژور روانپزشکی که مانع از شرکت مؤثر در جلسات میشود را نداشته باشد. بیمار (بستری در بیمارستان) بر اساس معیارهای DSM-5 مبتلا به اسکیزوفرنی، اختلال دوقطبی یا افسردگی اساسی باشد. بیمار مبتلا به اختلالات مصرف مواد به جز نیکوتین نباشد. سطح تحصیلات حداقل سیکل داشتن رضایت آگاهانه جهت شرکت در مطالعه
    حداقل به مدت 6 ماه از مراقبین اصلی بیمار باشد
    علایم حاد اختلالات روانپزشکی را نداشته باشد
    سواد خواندن و نوشتن داشته باشد
    سن بین 18 تا 60 سال داشته باشد
    بیمار (بستری در بیمارستان) بر اساس معیارهای DSM-5 مبتلا به اسکیزوفرنی، اختلال دوقطبی یا افسردگی اساسی باشد و مبتلا به اختلالات مصرف موادی به جز نیکوتین نباشد.
    داشتن رضایت اگاهانه برای شرکت در مطالعه
    Existence of psychiatric disorder and history of hospitalization in the caregiver
    Lack of caregiver participation in more than half of the classes
    Diagnosis of personality disorder in the patient
    وجود اختلال روانپزشکی و سابقه بستری در مراقب
    عدم شرکت مراقب در بیشتر از نیمی از کلاس ها
    تشخیص اختلال شخصیتی در بیمار
    Blocked randomization 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 a random concealment envelope is removed and the names and surnames of the people and their contact numbers are 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.
    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.
    تصادفی سازی بلوک بندی شده افراد واجد شرایط ورود به مطالعه، پس از کسب رضایت آگاهانه، وارد مطالعه خواهند شد(نمونه گیری مبتنی بر هدف). افراد بطور راندوم(تخصیص تصادفی با استفاده از سایتهای اختصاصی تصادفی سازی همچون sealed envelop) به دو گروه مداخله (سه جلسه گروهی 90 دقیقه ای آموزش سواد سلامت روان به فواصل یک هفته) و کنترل (سه جلسه گروهی 90 دقیقه ای با محتوای آموزش مهارت های زندگی) تقسیم خواهند شد. لازم به ذکر است تصادفی سازی بصورت بلوکی با استفاده از بلوکهای 4 یا 6 تایی انجام خواهد شد. پس از تخصیص تصادفی، نوع گروه تخصیص یافته برای هر فرد (برای مثال به صورت اعداد زوج و فرد) در برگه هایی نوشته شده و هر برگه درون یک پاکت در بسته قرارداده خواهد شد. پس از اطلاع رسانی به افراد، درصورتیکه فرد (مراقب سلامت) واجد شرایط ورود به مطالعه باشد از او درخواست می شود فرم رضایت آگاهانه را تکمیل نمایند. سپس به ترتیب یک پاکت(random concealment) برداشته شده و نام و نام خانوادگی افراد و شماره تماس انها جهت هماهنگی بعدی روی ان یادداشت می شود و طبق کد نوشته شده در پاکت افراد در یکی از دو گروه مداخله یا کنترل قرار میگیرند.
    افراد واجد شرایط ورود به مطالعه، پس از کسب رضایت آگاهانه، وارد مطالعه خواهند شد(نمونه گیری مبتنی بر هدف). افراد بطور راندوم(تخصیص تصادفی با استفاده از سایتهای اختصاصی تصادفی سازی همچون sealed envelop) به دو گروه مداخله (سه جلسه گروهی 90 دقیقه ای آموزش سواد سلامت روان به فواصل یک هفته) و کنترل (سه جلسه گروهی 90 دقیقه ای با محتوای آموزش مهارت های زندگی) تقسیم خواهند شد. لازم به ذکر است تصادفی سازی بصورت بلوکی با استفاده از بلوکهای 4 یا 6 تایی انجام خواهد شد. پس از تخصیص تصادفی، نوع گروه تخصیص یافته برای هر فرد (برای مثال به صورت اعداد زوج و فرد) در برگه هایی نوشته شده و هر برگه درون یک پاکت در بسته قرارداده خواهد شد. پس از اطلاع رسانی به افراد، درصورتیکه فرد (مراقب سلامت) واجد شرایط ورود به مطالعه باشد از او درخواست می شود فرم رضایت آگاهانه را تکمیل نمایند. سپس به ترتیب یک پاکت(allocation concealment) برداشته شده و نام و نام خانوادگی افراد و شماره تماس انها جهت هماهنگی بعدی روی ان یادداشت می شود و طبق کد نوشته شده در پاکت افراد در یکی از دو گروه مداخله یا کنترل قرار میگیرند.
    In this double-blind study, patients and clinical researchers were blinded to the type of intervention (type of training class).
    در این مطالعه دو سوکور، ارزیابان و محقق بالینی نسبت به نوع مداخله ( نوع کلاس آموزشی) کور سازی شده است.

Protocol summary

Study aim
Determining the effectiveness of educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital in Mashhad
Design
Clinical trial with control group, blocked, on 54 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Mental health literacy

General information

Reason for update
Completion and revision of inclusion criteria and blinding
Acronym
IRCT registration information
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
Registration date
2022-03-08, 1400/12/17
Registrant information
Name
Adeleh Abdolalizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3622 5814
Email address
adeleh137246@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-03, 1400/10/13
Expected recruitment end date
2023-03-04, 1401/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital
Public title
The effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients
Purpose
Supportive
Inclusion/Exclusion criteria
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:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
میدان آزادی، درب شرقی پردیس دانشگاه
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-12-07, 1400/09/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.620

Health conditions studied

1

Description of health condition studied
Health literacy of caregivers of psychiatric patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health literacy of caregivers of psychiatric patients
Timepoint
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.
Method of measurement
"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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
Control group: کلاس مهارت های زندگی
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital, Mashhad
Full name of responsible person
Adeleh Abdolalizadeh
Street address
Horr Ameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
ISH.IT@MUMS.AC.IR

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Meshkat
Street address
Azadi Square, east door of the university campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
MDS.Dean@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Adeleh Abdolalizadeh
Position
Resident of psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Block 1, No.8, Andishe 72 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9187187463
Phone
+98 51 3620 5991
Email
abdolalizadeha981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Adeleh Abdolalizadeh
Position
Resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.8, Block.1, Andisheh Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9187187463
Phone
+98 51 3620 5991
Email
abdolalizadeha981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Adeleh Abdolalizadeh
Position
Resident of psychiatric
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No.8. Block.1, Andishe 72 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9187187463
Phone
+98 51 3620 5991
Email
abdolalizadeha981@mums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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