| CTRI Number |
CTRI/2024/10/075931 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Changing the attitude about mental illness among Accredited Social health Activists –An health educational intervention study |
|
Scientific Title of Study
|
Reforming the attitude towards mental illness among rural public health care workers –An health educational intervention study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Tarikere Satyanarayana |
| Designation |
Associate Professor |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
Sri Devaraj Urs Medical College
Tamaka, Kolar-563103,
Karnataka, India.
Kolar
KARNATAKA
563103
India |
| Phone |
7892950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana S Murthy |
| Designation |
Assistant Professor |
| Affiliation |
Assitant Professor , SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
Sri Devaraj Urs Medical College
Tamaka, Kolar-563103,
Karnataka, India.
Department of Pyschiatry , Sri Devaraj Urs Medical Collge , SDUAHER , Tamaka
Kolar
KARNATAKA
563103
India |
| Phone |
7892950465 |
| Fax |
|
| Email |
drsahanasmurthy@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr PradeepTS |
| Designation |
Associate Professor |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
Sri Devaraj Urs Medical College
Tamaka, Kolar-563103,
Karnataka, India.
Kolar
KARNATAKA
563103
India |
| Phone |
7892950465 |
| Fax |
|
| Email |
dr.pradeep.ts@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, SDUAHER, Tamaka, Kolar, Karnataka,India
Code : 563103 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Medical College |
| Address |
Sri Devaraj Urs Medical Collge , SDUAHER, Tamaka , Kolar, Karnataka , India
563103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPradeep TS |
Sri Devaraj Urs Medical college |
Department of Community Medicine , II floor, College Building, Sri Devaraj Urs Medical College, SDUAHER, Tamaka, Kolar
Kolar
KARNATAKA |
9538075331
dr.pradeep.ts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Acadey of Higher Education & Research/Research and Development Cell/CENTRAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Health Attitude |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education Intervention |
Through qualitative research, development of health education module will be done by inter-professional team regarding attitude towards mental illness for ASHA workers. To conduct FGD among health professionals, purposive sampling will be used and module will be prepared. Deterministic Model is used for development of the health education module. Health education in form of lecture lasting more than 45 minutes will be prepared. 8 such lectures will be prepared which will be considered for Intervention group. Same content will be converted into Attractive leaflets which will be considered for placebo group. Contents will be equalized according to the checklist made, suggestions and recommendations from FGD and it will be incorporated. Module validation will be done by content validation using a Likert’s scale, content validity index (CVI) more than 0.9 will be included in this study. Both lecture and educational leaflets similarity will be verified by experts (expert validation).
To assess attitude towards mental illness, Community attitude towards mental illness (CAMI) questionnaire will be used. Baseline evaluation of attitude towards mental illness will be done on day 1 among ASHAs of all 6 taluks. After randomization through www.randomization.com software, ASHA from three taluk with go to Module lecture intervention group and other three taluk ASHA will receive Leaflet intervention module. This will be followed by health education to ASHA either by 8 hour lecture series for 8 consecutive weeks(Health Education Intervention Arm) and module leaflets for 8 weeks( Comparator arm). Lectures will be given by professional experts in the subject. Post health education intervention after 8 weeks, evaluation of attitude towards mental illness will be re -assessed using the same questionnaire.
|
| Comparator Agent |
Health education intervention |
Through qualitative research, development of health education module will be done by inter-professional team regarding attitude towards mental illness for ASHA workers. To conduct FGD among health professionals, purposive sampling will be used and module will be prepared. Deterministic Model is used for development of the health education module. Health education in form of lecture lasting more than 45 minutes will be prepared. 8 such lectures will be prepared which will be considered for Intervention group. Same content will be converted into Attractive leaflets which will be considered for placebo group. Contents will be equalized according to the checklist made, suggestions and recommendations from FGD and it will be incorporated. Module validation will be done by content validation using a Likert’s scale, content validity index (CVI) more than 0.9 will be included in this study. Both lecture and educational leaflets similarity will be verified by experts (expert validation). To assess attitude towards mental illness, Community attitude towards mental illness (CAMI) questionnaire will be used. Baseline evaluation of attitude towards mental illness will be done on day 1 among ASHAs of all 6 taluks. After randomization through www.randomization.com software, ASHA from three taluk with go to Module lecture intervention group and other three taluk ASHA will receive Leaflet intervention module. This will be followed by health education to ASHA either by 8 hour lecture series for 8 consecutive weeks(Health Education Intervention Arm) and module leaflets for 8 weeks( Comparator arm). Lectures will be given by professional experts in the subject. Post health education intervention after 8 weeks, evaluation of attitude towards mental illness will be re -assessed using the same questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASHAs with a minimum of 1 year experience in their field practice area irrespective of their training at the National mental health program |
|
| ExclusionCriteria |
| Details |
ASHAs with any mental illness or those who are on treatment for any mental illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of health education modules (lecture and leaflets) in bringing the change in attitude towards mental illness among ASHA workers. |
Health education in form of lecture lasting more than 45 minutes will be prepared. 8 such lectures will be prepared which will be considered for Intervention group which will be given for 8 consecutive week. Same content will be converted into Attractive leaflets which will be considered for placebo group distributed for 8 consecutive weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.pradeep.ts@gmail.com].
- For how long will this data be available start date provided 27-08-2024 and end date provided 27-07-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Stigmatization is a significant factor affecting social engagement, interpersonal and occupational functioning, and treatment and care processes of individuals with mental illnesses. Stigmatization can be seen also among village health professional’s especially health care staff like ASHAs. Considering the importance of language and expressions in stigmatization, studies and interventions in this field might contribute to reduce stigmatization. The results from the present study will provide insights for improving the effectiveness of the mental health illness and anti-stigma program for ASHA workers. Mental-heath-specific training will improve perceptions toward mental health and also will lead to a decrease in negative attitudes and stigma regarding mental health. |