| CTRI Number |
CTRI/2026/01/102308 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Reminiscence Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Remembering Past Life Experiences on Daily Activities and Well-Being in Older Adults with Memory Problems and Depression |
|
Scientific Title of Study
|
Effectiveness of Reminiscence Therapy on Quality of Life and Activities of Daily Living among Dementia with Comorbid Depression in Older Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha K |
| Designation |
Student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT-psychiatry division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
07200417423 |
| Fax |
|
| Email |
deekshakannaiyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneshwari S |
| Designation |
Assisstant Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT- Pediatric division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha K |
| Designation |
Student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
OT-psychiatry division, Ward No. 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
07200417423 |
| Fax |
|
| Email |
deekshakannaiyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT psychiatry division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamil Nadu, India - 603103 |
|
|
Primary Sponsor
|
| Name |
Deeksha K |
| Address |
OT psychiatry division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamil Nadu, India - 603103 |
| 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 Bhuvaneshwari S |
Chettinad General Hospital |
OT psychiatry division, Ward Number 24, Department of Occupational Therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, OMR, Kelambakkam, Chennai, Tamil Nadu, India - 603103
Chennai
TAMIL NADU |
9840016032
bhuvaneshwaris@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F039||Unspecified dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
QoL- AD – Quality of life in Alzheimers Disease
Barthel Index |
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
| Intervention |
Reminiscence Therapy |
Before enrolling each individual in the study, informed consent will be obtained from their patients/guardians, along with assent from the participants, using consent forms approved by the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). A total of 30 individuals, aged 65+ years and diagnosed with Dementia and comorbid Depression, will be recruited from the Occupational Therapy Department at Chettinad Hospital and other Clinics in the Chengalpattu District. Eligibility will be confirmed through initial screening using the Brief Cognitive Rating Scale and Geriatric Depression Scale. Participants meeting the inclusion criteria will be allocated to either an intervention group or a control group based on pre-existing conditions or convenience sampling (non-random assignment), in line with a quasi-experimental design. Pre-intervention assessment of Quality of Life and Activities of Daily Living will be conducted using the QoL-AD scale and Barthel Index. The intervention group will receive the Reminiscence Therapy, while the control group will continue with standard care without receiving any intervention from the researcher during this period. Each intervention session will last 45 minutes, conducted 3 times per week, over a period of 12 weeks. After the 12-week intervention period, post-intervention assessment of the same components Quality of Life and Activities of Daily Living will be conducted using the QoL-AD and Barthel Index. Pre- and post-intervention scores will be statistically analyzed to evaluate the effectiveness of the Reminiscence Therapy. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Individual diagnosed with Dementia and comorbid Depression based on Brief Cognitive Rating Scale and Geriatric Depression Scale. Brief Cognitive Rating Scale (BCRS) with a score Stage 3 to 4 indicating mild dementia. Age between 65+ years old No history of other physical illness |
|
| ExclusionCriteria |
| Details |
Other diagnoses or co-existing diagnoses with severe or acute psychiatric illness other than depression. Age Below 65 years Brief Cognitive Rating Scale (BCRS) with a score Stage 6 or 7 indicating severe to very severe dementia. Other physical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
QoL-AD
Barthel Index |
Quality of life will be assessed using QoL-AD at baseline (pre-intervention), and reassessed after completion of four weeks of Reminiscence therapy (post-intervention) and Activities of Daily Living can be assessed using Barthel Index at baseline (pre-intervention), and reassessed after completion of four weeks of Reminiscence therapy(post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="0"
Months="6"
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 study is non-randomized, Single - arm study evaluating the effectiveness of reminiscence
therapy on quality of life and activities of daily living among dementia with
comorbid depression in older adults. A
total of 30 individuals, aged 65+ years and diagnosed with Dementia and
comorbid Depression, will be recruited from the Occupational Therapy Department
at Chettinad Hospital and other Clinics in the
Chengalpattu District. Eligibility will be confirmed through initial screening
using the Brief Cognitive Rating Scale and Geriatric Depression Scale.
Participants meeting the inclusion criteria will be allocated to either an
intervention group or a control group based on pre-existing conditions or
convenience sampling (non-random assignment), in line with a quasi-experimental
design. Pre-intervention assessment of Quality of Life and Activities of Daily
Living will be conducted using the QoL-AD scale and Barthel Index. The
intervention group will receive the Reminiscence Therapy, while the control
group will continue with standard care without receiving any intervention from
the researcher during this period. Each intervention session will last 45
minutes, conducted 3 times per week, over a period of 12 weeks. After the
12-week intervention period, post-intervention assessment of the same
components Quality of Life and Activities of Daily Living will be conducted using
the QoL-AD and Barthel Index. Pre- and post-intervention scores will be
statistically analyzed to evaluate the effectiveness of the Reminiscence
Therapy. |