| CTRI Number |
CTRI/2024/09/074400 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of a simple technology based platform with self-help materials for common mental health problems and well-being for older adults |
|
Scientific Title of Study
|
Development of an easy-to-use platform containing resources for common mental health concerns for older adults under Center for Advanced Research on Digital interventions for mental health care |
| 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 Seema Mehrotra |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and NeuroSciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and NeuroSciences
(NIMHANS), Bangalore, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995192 |
| Fax |
|
| Email |
seema@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikesh Tripathi |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and NeuroSciences |
| Address |
Department of Clinical Psychology,National Institute of Mental Health and NeuroSciences NIMHANS, Bangalore, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026972213 |
| Fax |
|
| Email |
ravikesh@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravikesh Tripathi |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and NeuroSciences |
| Address |
Department of Clinical Psychology,National Institute of Mental Health and NeuroSciences NIMHANS, Bangalore, 560029
KARNATAKA
560029
India |
| Phone |
08026972213 |
| Fax |
|
| Email |
ravikesh@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Dr Seema Mehrotra |
| Address |
Dept of Clinical Psychology Govindaswamy center,NIMHANS Bangaluru- 560029, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Seema Mehrotra |
National Institute of Mental Health and NeuroSciences |
Dept of Clinical Psychology , Room 323, Govindaswamy center, National Institute of Mental Health and NeuroSciences Bangaluru, 560029, India
Bangalore
KARNATAKA |
09448503853
seema@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Behavioural Science Division), NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Common mental health concerns such as Depressive and Anxiety symptoms (Self-reported), may or may not have any psychiatric diagnosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Minimum 8 years of formal education;
Comfortable in reading and speaking English/Hindi/Kannada;
Self-report of common mental health concerns (depressive symptoms/anxiety symptoms) currently or in the last six months |
|
| ExclusionCriteria |
| Details |
Clinically significant cognitive and/or sensory-motor impairment or severe symptoms that makes it difficult to participate in the interview;Currently under treatment for major psychiatric conditions as per self-report including schizophrenia, schizotypal and delusional disorder, manic episode, bipolar affective disorder, severe depression with/without psychotic symptoms, Organic mental disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A simple technology based self help platform for common mental health concerns and well being developed using perspectives of older adults . Its usability will be assessed as the primary outcome |
At the end of 1st (First) week after exploration of the platform |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of a technology based self-help platform & exploring its acceptability |
At the end of the 1st week (First) after exploration of the platform |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Globally, there are 727 million persons aged 65 years or over in 2020. The population of older persons projected to reach over 1.5 billion in 2050 with women representing the majority of older persons (World Population Ageing Highlights, 2020). India has the second largest global population of ageing citizens with number increasing from 11 crores in 2011 to an estimated 23 crores in 2036. As per the Help Age India Report, 2022-2023 the elderly will comprise 20% of the India’s population in 2050. As per the National Mental Health Survey 2015-2016 (Gururaj et al., 2016), older adults had a higher lifetime (6.93%) and current (3.53%) prevalence of depressive disorders as compared to the younger adults (Sinha et.al., 2021). Data from the Longitudinal Ageing Study in India (LASI) revealed that 29% of the older adults had high psychological distress and this study also highlighted a high prevalence of social isolation and loneliness in older adults (Srivastava et al., 2021). All these figures indicate significant prevalence of common mental health problems and distress in older adults and highlight the potential role of self-help tools in empowering older adults who may be experiencing milder levels of distress/symptoms and for complementing professional help in others who may be seeking professional help for moderate levels of depression and anxiety. Although there is high penetration of internet and smartphone usage in India, the trends of use and research suggest that larger proportion of mental health app users are likely to be young adults /those in middle adulthood phases. Older adults may experience a variety of barriers including issues related to familiarity with technology and comfort in use of smartphone-based mental health apps. The existing research literature highlights the need for examining and taking in account perspectives of older adults, barriers and enablers to use of technology based mental health apps (Andrews et.al.,2019; Wilson, Heinsch, Betts et al. 2021; Vahia, Dickinson, & Trueba, 2022).). There is a dearth of research on these aspects in the Indian context. The study has the following objectives, 1. Explore the perspectives of older adults with common mental health concerns on the usefulness of various technology-based platforms for accessing resources related to self-help for mental health 2.Exploring preferences of the above-mentioned group in terms of various technology-based platforms for accessing resources related to self-help for mental health in terms of type of platforms and features /attributes of the platform/s 3. To develop a platform that utilizes the perspectives and preferences of older adults for hosting self-help material for common mental health concerns 4.To examine usability of the newly developed platform in older adults with common mental health concerns One to one interview will be conducted with older adults meeting the sample selection criteria till theme saturation (anticipated number being 15-20). An attempt will be made to recruit older adults from diverse backgrounds (urban/semi-urban, rural), all genders, variable educational levels, those visiting outpatient settings as well as those in community who self-report depressive /anxiety symptoms or distress. The sample selection will be purposive, and recruitment will be carried out through announcements in outpatient settings, a community wellbeing centre and via senior citizen groups (Sample selection criteria are mentioned in part 6 of the trial details). For the purpose of usability assessment, information on the platform that will be finally developed based on the initial phase will be shared with a sample of 10-20 older adults who will be selected like the phase 1 process. They will be provided access to the platform for exploring its content. A one-to-one interview will be conducted at the end of one week period for exploring their feedback on usability and potential acceptability. Modifications may be undertaken as per the feedback received. The expected outcome of the study is the creation of an easy to use WhatsApp based self-help resource for common mental health concerns and well being based on older adults’ perspectives. |