| CTRI Number |
CTRI/2025/11/097296 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Human Libraries as a Tool to Reduce Mental Health Stigma: Insights from a Pilot Program in Karnataka |
|
Scientific Title of Study
|
Karnataka Mental Health Manas Samvaadha: Effectiveness of Human Libraries in a Contact-based Intervention for Minimising Stigma and Prejudice against Mental Health in the Communitites: A Pilot Program from Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K S Meena |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Mental Health And Neurosciences, NIMHANS |
| Address |
Department of Mental Health Education
Dr. M V Govindaswamy Building National Institute of Mental Health And Neurosciences NIMHANS Hosur Road, Bengaluru Karnataka
Bangalore KARNATAKA 560029 India |
| Phone |
8762689735 |
| Fax |
|
| Email |
meenaksiyer@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajani P |
| Designation |
Deputy Director (Mental Health) |
| Affiliation |
Arogya Soudha, Bangalore |
| Address |
Arogya Soudha Binnyston Garden G Narayanakumar Road, Keshava Nagar Binnepete Bengaluru Karnataka
Bangalore KARNATAKA 560023 India |
| Phone |
9845329154 |
| Fax |
|
| Email |
dd6mhkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajani P |
| Designation |
Deputy Director (Mental Health) |
| Affiliation |
Arogya Soudha, Bangalore |
| Address |
Arogya Soudha Binnyston Garden G Narayanakumar Road Keshava Nagar Binnepete Bengaluru Karnataka
Bangalore KARNATAKA 560023 India |
| Phone |
9845329154 |
| Fax |
|
| Email |
dd6mhkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Health Mission(NHM) Government of Karnataka and Department of Rural Development and Panchayat Raj |
|
|
Primary Sponsor
|
| Name |
National Health Mission(NHM) Government of Karnataka |
| Address |
Binnyston Garden, G Narayanakumar Rd, Keshava Nagar, Binnipete, Bengaluru, Karnataka 560023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adarsha A M |
1. Government District Hospital, Ramanagara 2. Arivu Kendra, Public Library, Ramanagara |
1. NH275, Vinayakanagara, Ramanagara, 562159
2. No 1, Railway Station Road, Ramanagara,562159 Bangalore Rural KARNATAKA |
9538149595
adarsha8@gmail.com |
| Dr Girish Kumar D P |
1. Government Hospital 2. Nelamangala Government General Hospital 3.KantanakunteGP Digital Library |
1. Hoskote, NH-4, 562114
2. 39XR+FG9, Nelamangala Town,, 562123
3. 8GMJ+8PR, Kantanakunte,561203 Bangalore Rural KARNATAKA |
9964161331
drgirishdp@gmail.com |
| Dr Hemanth Kumar G |
1. MCH Hospital Gauribidanur 2. Government central library |
1. Govt.MC Hospital, Anandpura, Gauribidanur, Madanahalli, Karnataka 561208
2. JG78+4GX, Unnamed Road, Gauribidanur, Karnataka 561208 Bangalore Rural KARNATAKA |
9886916255
dr.hemanth2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F317||Bipolar disorder, currently in remission, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (4) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, (5) ICD-10 Condition: F200||Paranoid schizophrenia, (6) ICD-10 Condition: F401||Social phobias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human Library Contact-Based Intervention for Mental Health Stigma Reduction |
The total duration of the intervention is approximately 4 hours. Each ‘Book’ (person with lived experience of mental illness) interacts with ‘Readers’ (community members) in structured 30-minute sessions. While each Book participates for one 30-minute interaction, Readers engage with multiple Books over a total period of 4 hours.
Books are assessed on self-esteem, quality of life, and self-stigma, whereas Readers are assessed on mental health knowledge, reported and intended behavior, perceived devaluation and discrimination, and social distance. Both groups undergo pre-assessment one week prior to the Human Library session, immediate post-assessment after completion, and a follow-up post-assessment three months later to evaluate changes over time. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Persons with diagnosed mental illness from specified diagnostic categories (Schizophrenia, Bipolar Disorder, Anxiety Disorders, Substance Use Disorders, Obsessive-Compulsive Disorder, Depression), aged 18-60 years, asymptomatic for the past 12 months or more, currently receiving regular psychiatric treatment with good treatment adherence, maintaining regular clinical follow-ups, fluent in Kannada or English language, willing to undergo 7-day training program, willing to deliver intervention sessions, and able to provide informed consent. Individuals demonstrating good communication skills and willingness to share lived experiences.
Community members aged 18 years and above, fluent in Kannada or English language, able to provide informed consent, willing to participate in Human Library sessions and complete baseline, post-intervention and 3-month follow-up assessments. Individuals from urban and rural communities of Bangalore Rural, Chikballapur, and Ramanagara districts. No personal history of diagnosed mental illness. No current psychiatric treatment or medication.
|
|
| ExclusionCriteria |
| Details |
Individuals currently experiencing active psychiatric symptoms or acute relapse. Individuals with poor treatment adherence or irregular clinical follow-ups. Individuals with severe cognitive impairment or communication difficulties. Individuals with active substance abuse. Individuals with severe medical conditions that may compromise session delivery. Individuals unwilling or unable to undergo training. Individuals unable to maintain psychological stability during intervention delivery. Individuals with significant suicidal ideation or self-harm behaviors.
Individuals with any diagnosed mental health condition or currently experiencing psychiatric symptoms. Individuals currently on psychiatric medication or undergoing mental health treatment. Individuals with severe cognitive impairment affecting ability to provide informed consent. Individuals with acute medical or psychiatric emergencies. Individuals unable to communicate in Kannada or English. Individuals unwilling to participate in interactive sessions or complete follow-up assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in stigma and prejudice against mental health following Human Library contact-based intervention, measured by changes in scores on Stigma Scale, Social Distance Scale, and Perceived Devaluation and Discrimination (PDD) Scale |
1. Baseline
2. Immediate post intervention
3. Three months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in mental health knowledge and literacy (MAKS and RIBS scores) |
Baseline, Post-intervention, 3-month follow-up |
| Change in intended behaviors toward persons with mental illness (RIBS behavioral intentions subscale) |
Baseline, Post-intervention, 3-month follow-up |
| Qualitative feedback from persons with lived experience on intervention acceptability and impact |
Immediately post-intervention (via Focus Group Discussions) |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
01/12/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a pilot interventional study evaluating the effectiveness of Human Library, a contact-based intervention for reducing stigma and prejudice against mental illness in community settings. The study involves persons with lived experience of mental illness delivering 30-minute interactive sessions to groups of community members across 12 libraries in three districts of Karnataka: Bangalore Rural, Chikballapur, and Ramanagara. Participants with lived experience receive structured 7-day training prior to delivering interventions covering mental health awareness, stigma reduction, communication skills, and crisis management. Community members participate in sessions and complete assessments at three time points: baseline, immediately post-intervention, and 3-month follow-up. Primary outcomes include changes in stigma levels measured by Stigma Scale, social distance measured by Social Distance Scale, and perceived devaluation and discrimination measured by PDD Scale. Secondary outcomes assess mental health knowledge through MAKS and RIBS scales and measure behavioral intentions toward persons with mental illness. The study targets 72 community participants from three districts. This pilot study aims to establish the feasibility and effectiveness of contact-based interventions for mental health stigma reduction within community library settings. |