| CTRI Number |
CTRI/2024/11/076151 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Brief Intervention on knowledge and utilization of mental health services among caregivers |
|
Scientific Title of Study
|
Efficacy of Brief Intervention on Knowledge and utilization of Mental Health Services (BIKUMHS) among Caregivers of Persons with Severe Mental Illness |
| Trial Acronym |
BIKUMHS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ghanshyam Choudhary |
| Designation |
Ph.D. Scholar |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam. |
| Address |
Dept. of Psychiatric Social Work, LGB Regional Institute of Mental Health, Tezpur, Assam.
Academic Building, 4th Floor, Department of Psychiatric Social Work, LGBRIMH Tezpur Assam
Sonitpur
ASSAM
784001
India |
| Phone |
8368525367 |
| Fax |
|
| Email |
ghanshyam.psw@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrajeet Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam. |
| Address |
Dept. of Psychiatric Social Work, LGB Regional Institute of Mental Health, Tezpur, Assam.
Sonitpur
ASSAM
784001
India |
| Phone |
7896758196 |
| Fax |
|
| Email |
inraj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrajeet Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
LGB Regional Institute of Mental Health, Tezpur, Assam. |
| Address |
Dept. of Psychiatric Social Work, LGB Regional Institute of Mental Health, Tezpur, Assam.
Sonitpur
ASSAM
784001
India |
| Phone |
7896758196 |
| Fax |
|
| Email |
inraj2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| LGBRIMH Tezpur, Assam, India - 784001 |
|
|
Primary Sponsor
|
| Name |
LGBRIMH |
| Address |
LGB Regional Institute of Mental Health, Tezpur, Assam- 784001 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Soumik Sengupta |
Room no. 26, OPD LGBRIMH |
Department of Psychiatric Social Work, LGBRIMH, Tezpur - 784001
Sonitpur
ASSAM |
8471937677
dr.soumiksengupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, LGBRIMH, Tezpur, Assam. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of Persons with Severe Mental Illness
(Schizophrenia, BPAD, OCD).
Mental Health Professionals. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Group |
The researcher will develop a booklet of brief intervention. To develop the booklet, the researcher will conduct the need analysis with caregivers and mental health professionals to understand the perspective of utilization of mental health services. The developed booklet will be validated by the experts. After that caregivers of persons with severe mental illness receiving treatment from IPD and OPD; and mental health professionals, fulfilling the inclusion criteria will be considered for recruitment in the study, and informed consent will be taken.
The caregivers will be divided into two groups; one will be the intervention group and the other will be the waitlist group. Pre-assessment will be done in both groups, and the intervention group will be provided with intervention. Post-assessment will be done after 4 weeks to 8 weeks (within 2 months) in both groups and the waitlist group will receive intervention after post-assessment.
|
| Comparator Agent |
Waitlist Group |
The researcher will do the pre assessment to see the status of knowledge and utilization among caregivers of persons with severe mental illness who are receiving treatment from LGBRIMH, they will be kept on Treatment as Usual(TAU). Post assessment will be done after 4 weeks to 8 weeks (2 Months), and the results will be compared with intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Caregivers of persons with severe mental illness receiving services of LGBRIMH
2. Co-living with the patient for more than a year.
3. Age range 18 years or above.
4. Caregivers who can understand English, Hindi or Assamese language.
5. Participants who will be giving consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Caregivers reported any mental illness or chronic physical illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of a booklet on knowledge and utilization of mental health services (BIKUMHS) for persons with severe mental illness |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Brief Intervention on Knowledge and Utilization of Mental Health Services. |
1 year |
| Status of knowledge and utilization of mental health services among caregivers of persons with severe mental illness. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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)
|
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
|
There exists a notable gap in the literature regarding the specific efficacy of brief interventions tailored to this population for knowledge and utilization of mental health services. While brief interventions have shown promise in various mental health contexts, including reducing stigma and enhancing knowledge about mental illness, their effectiveness specifically among caregivers of individuals with SMI on knowledge and utilization of mental health services in the Indian context remains understudied. So, the present study has been framed to bridge this gap by assessing the knowledge and providing brief intervention on knowledge and utilization of mental health services to the study participants. The purpose of this study is to develop and test the efficacy of a brief intervention on knowledge and utilization of mental health services, highlighting potential gaps, obstacles, cost-effectiveness, and areas for improvement. This study aims to bring useful insights into the perspectives of caregivers, that can help to shape focused interventions, training programs, and legislative changes to improve the overall mental health support system.
|