Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001223729
Ethics application status
Approved
Date submitted
25/08/2022
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mental Health Literacy and Virtual Training Program Pilot Study for Primary Health Care Employees
Scientific title
Mental Health Literacy and Virtual Training Program Pilot Study for Primary Health Care Employees
Secondary ID [1] 307844 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Literacy 327452 0
Condition category
Condition code
Public Health 324578 324578 0 0
Health promotion/education
Mental Health 324579 324579 0 0
Anxiety
Mental Health 324580 324580 0 0
Depression
Mental Health 324581 324581 0 0
Other mental health disorders
Public Health 324582 324582 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention tool of the project;
It is a training program for primary health care professionals aimed at mental problems that are common in society. All of the trainers are academicians, have at least 10 years of professional experience in their field (Prof. and Associate Professor)
Preparation of educational content
A training program with different content will be prepared for the physician and family health workers group. For the physician group, it is planned to focus on early diagnosis, crisis intervention, rational use of mental health medications, counseling for mental health and cooperation with community mental health centers .
The family health workers group is planned to include mental health awareness, crisis intervention, mental health counseling and cooperation with community mental health centers . The content of the training will be revised according to the preliminary test result and the request of the participants.
In order to create the content of the training, a survey study will be conducted approximately 2 months before the intervention to determine the field need. According to the survey results, revisions will be made in the educational content.

Presentation of educational content
the prepared 2 different educational contents will be applied online to a physician group and an family health workers group. The training is planned to be held in 4 sessions (2 groups of family physician training and 2 groups of family health worker training are planned). Each training content will be given with 4 training modules of 35 minutes. After each training, 10-minute breaks will be given. A total of 3 hours of training is planned. The trainings will be provided in the form of live workshops through the video conferencing platform. It is planned to conduct the trainings during off-hours, to use online chat rooms to keep the interaction active and to keep the communication with the trainers on e-mail active. There will be 1 educator and a maximum of 50 participants in each training module. 1 person from the research team will take part in the follow-up of the preliminary and final tests of the module, recording the questions and answers in the training and technical support. The list of participants will be checked by the researcher providing technical support. Immediately before the presentation of the training content, the pre-test appropriate to the module content and the final test will be applied at the end of the module.
One of the trainers will manage the online chat rooms to ensure that the topics are appropriate and provide support to the participants if necessary.
Intervention code [1] 324308 0
Treatment: Other
Intervention code [2] 324309 0
Prevention
Intervention code [3] 324310 0
Early detection / Screening
Comparator / control treatment
The control group of the study were primary health care workers who were not included in the training program.
Control group
Active

Outcomes
Primary outcome [1] 332407 0
A questionnaire will be applied to all family physicians and family health workers working in primary health services in Kayseri Province (control and experimental groups) to determine the content of education and to reveal their mental health literacy status.The survey content will include demographic data, frequently encountered psychiatric problems, information about mental illnesses and emergency situations, attitude and behavior questions.
Timepoint [1] 332407 0
First test 2 months before training, 2. the test will be applied 3 months after training
Primary outcome [2] 332481 0
The mental health literacy of physicians and family health workers will be evaluated by Göktas et al. (2019) using the Turkish Mental Health Literacy Scale (RSOY).
Timepoint [2] 332481 0
First test 2 months before training, 2. the test will be applied 3 months after training
Secondary outcome [1] 413388 0
In order to assess the attitude of physicians and family health workers towards mentally troubled individuals, the Social Attitude Scale for Individuals with Mental Problems, the validity and reliability of which was studied in Turkish by Bag and Ekinci in 2006, will be applied.
Timepoint [1] 413388 0
First test 2 months before training, 2. the test will be applied 3 months after training
Secondary outcome [2] 413700 0
In order to evaluate the beliefs of physicians and family health workers about mental illnesses, the Beliefs Scale About Mental Illness, which was conducted by Bilge, in a Turkish validity and reliability study in 2008, will be applied.
Timepoint [2] 413700 0
First test 2 months before training, 2. the test will be applied 3 months after training
Secondary outcome [3] 413702 0
The "Rational Mental Health Drug Use Knowledge and Behavior of Primary Care Physicians" questionnaire about the rational use of psychiatric drugs, which was specially prepared by the researchers for this study, will be applied.
Timepoint [3] 413702 0
First test 2 months before training, 2. the test will be applied 3 months after training

Eligibility
Key inclusion criteria
1- To be working as a general practitioner family physician in family medicine affiliated to Kayseri Provincial Health Directorate.
2- To work as a family health worker in family medicine affiliated to Kayseri Provincial Health Directorate
3- To have an infrastructure that can access online education during the training hours
4- To participate in at least 90% of the training program
5- To agree to participate in the survey for research
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Not to accept to enter the training and survey application for research.
2. Not participating in more than 10% of the training program
3. Becoming a family doctor specialist

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization of the study will be performed with computer support.(www.randomizer.org )
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Groups will be examined and it will be confirmed that there is no difference between the groups in terms of age, gender and rural urban distribution. In case there is no equality in the randomization of groups, one-to-one matching will be made.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Kayseri is one of the 30 metropolitan cities in Turkey, located in Central Anatolia and has a population of 1,435,670. The average number of population per family doctor is between 3,051 - 3,166. The average of Turkey is also approximately in this number range. In terms of specialist family doctors, it has a lower rate than the average in Turkey. There are 461 family physicians working in Kayseri, 46 of whom are family physician specialists and 415 of whom are general practitioners. All 415 general practitioner family physicians and 438 family health workers working in Kayseri Province will constitute the universe of the research.

All survey data will be evaluated in SPSS 25 program and internal reliability analysis (Cronbach's Alpha number) will be calculated. The Deciency of the score differences between the two groups according to the normal distribution will be evaluated by the Kolmogorov Smirnov Test and the statistical tests to be performed will be determined according to this result. The results of the T tests for the normal distribution is appropriate for those who are not appropriate, Mann-Whitney U test and Kruskal Wallis test, intervention and control groups in demographic characteristics of the participants, age, gender and occupational differences to assess the impact of independent samples, Pearson's chi-square test will be compared.The intervention and control group will be surveyed twice (at the beginning and after the intervention), and variance analysis will be used to evaluate repeated measurements.
Logistic regression will be used to evaluate changes in binary variables. P<0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
853
Accrual to date
Final
Recruitment outside Australia
Country [1] 24982 0
Turkey
State/province [1] 24982 0

Funding & Sponsors
Funding source category [1] 312126 0
Government body
Name [1] 312126 0
Türkiye Bilimsel ve Teknolojik Arastirma Kurumu
Country [1] 312126 0
Turkey
Primary sponsor type
Government body
Name
Türkiye Bilimsel ve Teknolojik Arastirma Kurumu
Address
TÜBITAK Baskanlik. Tunus Caddesi No:80. 06680 Kavaklidere Ankara
Country
Turkey
Secondary sponsor category [1] 313647 0
None
Name [1] 313647 0
Address [1] 313647 0
Country [1] 313647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311517 0
Erciyes University Clinical Research Ethics Committee
Ethics committee address [1] 311517 0
Yenidogan, Turhan Baytop Sokak No:1, 38280 Talas/Kayseri
Ethics committee country [1] 311517 0
Turkey
Date submitted for ethics approval [1] 311517 0
10/09/2021
Approval date [1] 311517 0
06/10/2021
Ethics approval number [1] 311517 0
643

Summary
Brief summary
Depression, anxiety and somatoform diseases common mental health problems in society. If these diseases are not treated at an early stage, they can lead to a decrease in the quality of life, economic and professional losses, decaying interpersonal harmony, alcohol and substance abuse or addiction, and irreversible consequences such as suicide.Epidemics, migration, economic depressions and personal health problems experienced by societies can lead to the emergence of mental problems.In order to protect the mental health of the public, family physicians providing public services should take measures to protect mental health, early diagnosis and treatment, and increase the capacity of the health service at the first stage.In addition, there are no studies conducted on midwives and nurses who work as family health workers in family medicine in Turkey. A randomized controlled double-blind trial design is planned. A pre-test questionnaire will be used to assess the current situation. According to the preliminary test results, a training program will be created in accordance with the needs analysis. 2 training programs with different content will be prepared for ale physicians and family health workers. The educational content will be presented online. After the training, the effectiveness of the training will be evaluated with the final test application.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121378 0
Dr Emel GÜDEN
Address 121378 0
Kayseri Provincial Health Directory. R&D Unit. Hunat Mahallesi. Nuh Naci Yazgan Caddesi.
No: 2
Country 121378 0
Turkey
Phone 121378 0
+903522226996
Fax 121378 0
Email 121378 0
emel.gudenaltintas@saglik.gov.tr
Contact person for public queries
Name 121379 0
A/Prof Arda BORLU
Address 121379 0
Erciyes University. Public Health Department. Kösk Mahallesi. Prof. Dr. Turan Feyzioglu Caddesi. No:42
Country 121379 0
Turkey
Phone 121379 0
+903522076666
Fax 121379 0
Email 121379 0
ardaborlu@gmail.com
Contact person for scientific queries
Name 121380 0
Dr Emel GÜDEN
Address 121380 0
Kayseri Provincial Health Directory. R&D Unit. Hunat Mahallesi. Nuh Naci Yazgan Caddesi.
No: 2
Country 121380 0
Turkey
Phone 121380 0
+903522226996
Fax 121380 0
Email 121380 0
emel.gudenaltintas@saglik.gov.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.