View older revisions Content changed at 2024-06-12, 1403/03/23

Protocol summary

Study aim
Determining effectiveness of "mental health first aid (MHFA) for depression" training by using critical thinking approach on the depression literacy among health ambassadors
Design
A cluster randomized controlled trial, with an intervention group and a control group, on 250 health ambassadors, randomization using a random number table.
Settings and conduct
Place of study: Centers for Integrated health service delivery of Islamshahr Health Network. Study population: health ambassadors from 10 Centers for Integrated health service delivery that are selected based on cooperation and implementation criteria; Listed and 5 centers are randomly assigned to the intervention group and 5 centers to the control group using a random number table. Blinding won't be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with at least 2 years of work experience as health ambassadors, average age between 25 and 45 years, consent to participate in the study Non-entry criteria: A history of diagnosed depression in the individual, Women with less than 2 years of experience as health ambassadors
Intervention groups
Intervention group: mental health first aid package for depression is taught during eight sessions (duration is one and a half hours) with methods problem based learning and role-playing for two months. Control group: No special action is taken in this group.
Main outcome variables
Recognizing depression; Belief in mental Health first aid in the person with depression disorder; the intention to perform mental Health first aid in the person with a depressive disorder; attitude towards social stigma; Belief in prevention and intervention measures in people with depression disorder; Depression literacy

General information

Reason for update
The project contract related to this trial was signed with the number 1402-4-99-69583 on June 10, 2024 , and the start date of patient recruitment has also been postponed to provide financial resources.
Acronym
IRCT registration information
IRCT registration number: IRCT20231225060521N1
Registration date: 2024-01-21, 1402/11/01
Registration timing: prospective

Last update: 2024-06-12, 1403/03/23
Update count: 2
Registration date
2024-01-21, 1402/11/01
Registrant information
Name
Fatemeh Hallajian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5649 1094
Email address
fatemeh.ha9955@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of "mental health first aid (MHFA) for depression" training by critical thinking approach on the depression literacy among health ambassadors
Public title
The effectiveness of "mental health first aid (MHFA) for depression" training on the depression literacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with at least 2 years of work experience as health ambassadors Average age between 25 and 45 years Consent to participate in the study
Exclusion criteria:
A history of diagnosed depression in the individual Women with less than 2 years of experience as health ambassadors
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 250
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a cluster randomized controlled trial and sampling is done by cluster random method. First, a list of all Centers for Integrated health service delivery is prepared, which includes 14 urban Center for Integrated health service delivery and 5 rural Center for Integrated health service delivery. After coordinating with Tehran University of Medical Sciences and Islamshahr Health Network, 10 centers will be selected based on their interest and willingness to cooperate in the implementation of the project. Then, five centers are randomly assigned to the intervention group and five centers to the control group using a table of random numbers.
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 Tehran University of Medical Sciences
Street address
Room 604, sixth floor, Tehran University of Medical Sciences Central Building, Qods street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.TUMS.SPH.REC.1402.256

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Recognizing depression
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

2

Description
Belief in mental Health first aid in the person with depression disorder
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

3

Description
Intention to perform mental Health first aid in the person with depression disorder
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

4

Description
Attitude towards social stigma
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

5

Description
Belief in prevention and intervention measures in people with depression disorder
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

6

Description
Depression literacy
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
mental health literacy questionnaire developed by Reavley and colleagues

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, mental health first aid package for depression is taught during eight sessions (the duration of each session is one and a half hours) with methods based on problem base learning and role playing for two months by researchers. A week of practice and study is given between training sessions. The first meeting will be held as an introduction and description of the activities, explaining the research goals and the task of each person during the intervention, and the next meetings will be held according to the set schedule.
Category
Other

2

Description
Control group: No special action is taken in this group. In order for the participants of the control group centers to benefit from the educational materials, the educational package file will be available to these centers after the end of the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Centers for Integrated health service delivery of Islamshahr Health Network
Full name of responsible person
Fatemeh Hallajian
Street address
Islamshahr Health Network, at the beginning of Bahram Abad, Before the Namaz Square, Saveh Road
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 5108 1000
Email
Ravabet-esl@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Sixth Floor, Central University Organization, at the corner of Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
fatemeh.ha9955@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hallajian
Position
Master of Health Education and Promotion Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
TUMS School of Public Health, Porsina St, Qods St, Enqelab St.
City
Tehran
Province
Tehran
Postal code
3315848988
Phone
+98 21 5649 1094
Fax
Email
fatemeh.ha9955@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ensiyeh Jamshidi
Position
Assistant Professor Of Health Education and Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
TUMS School of Public Health, Porsina St, Qods St, Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Email
ensiyeh_jamshidi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Hallajian
Position
Master of Health Education and Promotion Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
TUMS School of Public Health, Porsina St, Qods St, Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
Email
fatemeh.ha9955@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
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
Title and more details about the data/document
Participant data related to the primary outcome are recorded.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Meta-analyses of the effectiveness of mental health interventions, journals requesting data from our team, the research team of this study
Under which criteria data/document could be used
For use in meta-analysis studies
From where data/document is obtainable
Email of the responsible person
What processes are involved for a request to access data/document
E-mail
Comments
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