| CTRI Number |
CTRI/2025/05/086520 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Positive Psychology Interventions] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
The Impact of Positive Aging Intervention on Elderly in India |
|
Scientific Title of Study
|
The Impact of Positive Aging Intervention on Flourishing of Elderly in India: A Pan-India Cluster Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratishtha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES |
| Address |
Department of Psychology,
School of Social Sciences, MS Ramaiah University of Applied Sciences, New BEL Road,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
8250094150 |
| Fax |
|
| Email |
pratishtha.ss@msruas.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratishtha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES |
| Address |
Department of Psychology,
School of Social Sciences, MS Ramaiah University of Applied Sciences, New BEL Road,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
8250094150 |
| Fax |
|
| Email |
pratishtha.ss@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pratishtha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES |
| Address |
Department of Psychology
School of Social Sciences, MS Ramaiah University of Applied Sciences, New BEL Road,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
8250094150 |
| Fax |
|
| Email |
pratishtha.ss@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707
Fax: 91-11-26588662
Email:icmrhqds@sansad.nic.in |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research
Department of Health Research
Ministry of Health & Family Welfare
Government of India
Ansari Nagar, New Delhi - 110029, India
www.icmr.gov.in |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aradhana S Talwar |
School of Social Sciences
MS Ramaiah University of Applied Sciences
Bangalore 560054
Karnataka |
| Dr Sudharsana V Iyengar |
School of Social Sciences
MS Ramaiah University of Applied Sciences
Bangalore 560054
Karnataka |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan Bairwa |
All India Institute of Medical Sciences, Delhi |
Room No 28
Centre for Community Medicine, Old OT Block
All India Institute of Medical Sciences
Ansari Nagar New Delhi
INDIA 110029
New Delhi
DELHI |
09718835447
mohanbairwa@aiims.edu |
| Dr Divyamol K Sasidharan |
Amrita Vishwa Vidyapeetham, AIMS Health Sciences,Ernakulum |
Assistant professor,
Department of Geriatrics,
Amrita Vishwa Vidyapeetham,
AIMS Health Sciences Campus,
AIMS Ponekkara P. O.,
Kochi, Kerala 682 041, India
Ernakulam
KERALA |
9995653009
divz64@gmail.com |
| Dr Ranjan Ranjan Prusty |
ICMR-National Institute for Research in Reproductive and Child Health, Mumbai |
Scientist C,
Department of Biostatistics,
ICMR-National Institute for Research in Reproductive and Child Health Jehangir Merwanji Street, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
7070097387
prustyr@nirrch.res.in |
| Dr Kajori Banerjee |
Indian Statistical Institute, Kolkata |
Assistant Professor
Population Studies Unit, Kolkata
Social Sciences Division
Kolkata Headquarters
Plot No, 203, Barrackpore Trunk Rd, Dunlop, Bonhooghly Government Colony, Baranagar, West Bengal 700108
Kolkata
WEST BENGAL |
98205 06794
kajori.b@isical.ac.in |
| Dr Pratishtha Bhattacharyya |
MS Ramaiah University of Applied Sciences Bangalore, Bangalore |
School of Social Sciences
MS Ramaiah University of Applied Sciences Bangalore 560054
Bangalore
KARNATAKA |
8250094150
pratishtha.ss@msruas.ac.in |
| Dr Selvamani Y |
SRM Institute of Science and Technology,Chennai |
SRM School of Public Health
Medicine and Health Sciences Kattankulathur Chennai 603203
Chennai
TAMIL NADU |
09082480154
selvamay@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
| ICMR-NIRRCH ETHICS COMMITTE FOR HUMAN STUDIES |
Approved |
| Institute Ethics Committee |
Approved |
| SRM Medical College Hospital- Faculty Institutional Ethics Committee |
Approved |
| The Indian Statistical Institute Review Committee for Protection of Research Rights to Humans (ISI-RCPRRH) |
Approved |
| University Ethics Committee for Human Trials |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Severe depression
Cognitive impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
The control group wont receive any intervention while the treatment group is receiving intervention. It will be waitlisted and receive the intervention once the original study is completed that is immediately after 6 months of the original intervention gets completed. |
| Intervention |
The intervention module is titled swarna mitra and it is based on positive psychological interventions |
The study will involve training institutionalized elderly in positive psychology intervention. We have titled the intervention module "Swarna Mitra". It constitutes 26-week of structured intervention plan targeting gratitude, compassion, forgiveness, optimism, savoring, altruism, meaning of life, and hope among participants, particularly older adults in old age homes. Key highlights include:
1. Phased Intervention Modules:
o Optimism: Exercises for imagining the best possible self and reflection.
o Hope: Sessions using narrative techniques like hope finding and hope bonding, hope enhancing and hope reminding.
o Gratitude: Sessions using activities like counting blessings and expressive writing.
o Forgiveness : The REACH model of forgiveness, will be used it is a structured approach that guides individuals through five steps: Recalling the hurt, Empathizing with the offender, Altruistically offering forgiveness, Committing to forgive, and Holding onto forgiveness. This model helps individuals move past resentment and achieve emotional healing by fostering empathy and intentional forgiveness.
o Compassion: Self-compassion training based on the Mindful Self-Compassion model involving mediation practice.
o Savoring: Exercises on savoring moments, reminiscence, and mindful photography using the Savoring Beliefs Inventory.
o Altruism: Activities fostering altruistic behavior assessed with the Helping Attitudes Scale.
o Meaning of Life: Life review interventions include asking participants to share the concept of life review and explore the meaning it holds for them.
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 65 and above. Willingness to participate in the study without coercion and provide informed consent to participate in the study. Absence of severe cognitive impairment
Absence of severe depressive symptoms |
|
| ExclusionCriteria |
| Details |
Presence of cognitive impairment
Presence of severe depression |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome will be measured using the following instruments:
• Flourishing- Butler and Kern’s PERMA-Profiler to measure flourishing consisting of 23 items.
• Psychological well-being- Psychological well-being is conceptualized by Carol Ryff as six dimensions namely autonomy, environmental mastery, purpose in life, positive relations with others, personal growth, and self-acceptance. It will be measured by Ryff’s Psychological Well-Being Scales (PWB), Long version 84 items version.
• Subjective happiness- Lyubomirsky, and Lepper’s subjective happiness scale consisting of 4 items. |
baseline, 6 months after baseline and 8 months after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes will be measured using the following instruments:
• Loneliness- A 20-item UCLA Loneliness Scale will be used to measure loneliness.
• Anxiety- Anxiety will be measured by the Indian adaptation of the Geriatric Anxiety Inventory.
• Depressive symptoms- Depressive symptoms will be measured by the Geriatric Depression Scale .
• Quality of life- Quality of life will be measured by the World Health Organization QoL (WHOQOL-BREF) scale.
• Quality of sleep - The Pittsburgh Sleep Quality Index (PSQI) 1will be used to measure quality of sleep.
• Positive and negative affect- It will be measured by Positive and Negative Affect Schedule (PANAS).
|
baseline, 6 months after baseline and 8 months after baseline |
|
|
Target Sample Size
|
Total Sample Size="4800"
Sample Size from India="4800"
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 3 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study involves a 26-week intervention module called ‘Swarna Mitra’, which uses positive psychology activities—such as practicing gratitude, optimism, compassion, forgiveness, helping others, enjoying small moments, using personal strengths, finding meaning in life, and building hope—to support the mental and emotional well-being of older adults living in old age homes. The study will be conducted in six major Indian cities: Delhi, Mumbai, Kolkata, Kochi, Bangalore, and Chennai. In each city, 20 old age homes will participate. Out of these, 10 will be randomly selected to receive the Swarna Mitra program, while the other 10 will be placed on a waitlist and offered the program later. The study will assess self-reported levels of flourishing, psychological well-being (which includes autonomy, environmental mastery, purpose in life, positive relations with others, personal growth, and self-acceptance), and subjective happiness. It will also look at changes in loneliness, anxiety, depressive symptoms, quality of life, sleep quality, and positive and negative affect. |