Protocol summary
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Study aim
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Determining effectiveness of "mental health first aid (MHFA) for depression" training by using critical thinking approach on the depression literacy among health ambassadors
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Design
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A cluster randomized controlled trial, with an intervention group and a control group, on 250 health ambassadors, randomization using a random number table.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-01-21, 1402/11/01
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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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2024-06-30, 1403/04/10
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Expected recruitment end date
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2024-11-30, 1403/09/10
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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 "mental health first aid (MHFA) for depression" training by critical thinking approach on the depression literacy among health ambassadors
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Public title
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The effectiveness of "mental health first aid (MHFA) for depression" training on the depression literacy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 45 years old
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Gender
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Female
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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:
250
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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2023-12-24, 1402/10/03
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Ethics committee reference number
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IR.TUMS.SPH.REC.1402.256
Health conditions studied
1
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Description of health condition studied
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Depression
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ICD-10 code
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F32
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ICD-10 code description
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Depressive episode
Primary outcomes
1
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Description
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Recognizing depression
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
2
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Description
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Belief in mental Health first aid in the person with depression disorder
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
3
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Description
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Intention to perform mental Health first aid in the person with depression disorder
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
4
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Description
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Attitude towards social stigma
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
5
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Description
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Belief in prevention and intervention measures in people with depression disorder
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
6
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Description
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Depression literacy
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Timepoint
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Before the intervention and two months after the end of intervention
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Method of measurement
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mental health literacy questionnaire developed by Reavley and colleagues
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Other
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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Tehran 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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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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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
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Title and more details about the data/document
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Participant data related to the primary outcome are recorded.
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When the data will become available and for how long
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6 months after the results are published
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To whom data/document is available
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Meta-analyses of the effectiveness of mental health interventions, journals requesting data from our team, the research team of this study
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Under which criteria data/document could be used
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For use in meta-analysis studies
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From where data/document is obtainable
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Email of the responsible person
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What processes are involved for a request to access data/document
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E-mail
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Comments
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