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CTRI Number  CTRI/2025/09/094466 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Progressive Muscle Relaxation]  
Study Design  Other 
Public Title of Study   Effect of Stress management on depression, anxiety, stress, insomnia, and dementia in the elderly population 
Scientific Title of Study   Effect of Stress management on depression, anxiety, stress, insomnia, and dementia in the elderly population of Burdwan district of West Bengal- A quasi-experimental non-randomized study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arunima Chaudhuri 
Designation  Professor department of Physiology 
Affiliation  Burdwan Medical College 
Address  Krishnasayar south, Borehat, Burdwan
Professor Department of Physiology, Burdwan Medical College, Post office: Rajbati, Baburbag, Burdwan 713104
Barddhaman
WEST BENGAL
713102
India 
Phone  9531638559  
Fax    
Email  arunimachaudhuri4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arunima Chaudhuri 
Designation  Professor department of Physiology 
Affiliation  Burdwan Medical College 
Address  Krishnasayar south, Borehat, Burdwan
Professor Department of Physiology, Burdwan Medical College, Post office: Rajbati, Baburbag, Burdwan 713104
Barddhaman
WEST BENGAL
713102
India 
Phone  9531638559  
Fax    
Email  arunimachaudhuri4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arunima Chaudhuri 
Designation  Professor department of Physiology 
Affiliation  Burdwan Medical College 
Address  Krishnasayar south, Borehat, Burdwan
Professor Department of Physiology, Burdwan Medical College, Post office: Rajbati, Baburbag, Burdwan 713104
Barddhaman
WEST BENGAL
713102
India 
Phone  9531638559  
Fax    
Email  arunimachaudhuri4u@gmail.com  
 
Source of Monetary or Material Support  
Burdwan Medical College, Department of Physiology, Baburbag, Burdwan, 713104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arunima Chaudhuri  Burdwan Medical College and Hospital  Department of Physiology, Burdwan Medical College. Baburbagh Post office: Rajbati, Burdwan 713104
Barddhaman
WEST BENGAL 
09531638559

arunimachaudhuri4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Burdwan Medical College, IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT Applicable 
Intervention  Progressive muscle relaxation  Stress management technique for 2 years 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Males and females above the age of 60 with a minimum educational level of 12th standard of education attending the Medicine outpatient department of Burdwan Medical College will be included. 
 
ExclusionCriteria 
Details  Subjects having severe cognitive impairment 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in the progression of cognitive decline and depression, stress, anxiety, and insomnia levels: Assessment will be done at 6 months, 1 year, 1.5 years, and 2 years  Decrease in the progression of cognitive decline and depression, stress, anxiety, and insomnia levels at 6 months, 1 year, 1.5 years and 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in cardiovascular profile and quality of life  0.5 year, 1 year, 1.5 years, 2 years 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   25/09/2025 
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="3"
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  

Title: Effect of Stress management on depression, anxiety, stress, insomnia, and dementia in the elderly population of Burdwan district of West Bengal- A quasi-experimental

non-randomized study

Synopsis:

The mental health needs of the global population have been gaining attention as a major public health concern in recent times. The postmodern world has presented human civilization with numerous challenges, and stress has become an integral part of our lives. Stress is a major contributor to sleep disturbances, one of the most important concerns in public health in recent times. Insomnia hurts the quality of life across the globe. Sleep disturbances are associated with a variety of physical and mental health complications.

Depressed older adults usually display cognitive changes, somatic symptoms, and loss of interest, so insomnia may often be overlooked as a risk factor for late-life depression. The proportion and size of the elderly population are increasing over time worldwide, and according to the Indian Population Census 2011, there are nearly 104 million elderly persons (aged 60 years or above). Depression is less prevalent among older adults, but it can have serious consequences. The devastating consequences of late-life depression are an important public health problem. Late-life depression is associated with an increased risk of dementia, and late-life depression may be an early manifestation of dementia rather than an increased risk for dementia. Research on the correlation between Depression, Anxiety, Stress, Insomnia, and Dementia has important implications for understanding the underlying biology and for providing information for the early identification of dementia. Considering the above facts, the present study will be conducted among the elderly population attending Burdwan Medical College and Hospital so that early cognitive impairment and mental health problems, and their consequences can be recognized, and possible remedial measures can be implemented.

Introduction:

The mental health necessities of the global population have been gaining attention as a major public health concern in recent times. The postmodern world has put human civilization to multiple challenges and stress has become a part and parcel of our lives. Stress is a major contributor to sleep disturbances, one of the most important concerns in public health in recent times and insomnia has a negative impact on the quality of life across the globe.13-15 Lack of sleep has significant negative effects on personal life and results in the reduction of work performance. Sleep disturbances are associated with a variety of physical and mental health complications.1-6

Depressed older adults usually display cognitive changes, somatic symptoms, and loss of interest, so insomnia may often be overlooked as a risk factor for late-life depression. The proportion and size of the elderly population are increasing over time worldwide, and according to the Indian Population Census 2011, there are nearly 104 million elderly persons (aged 60 years or above). Depression has been found to be less prevalent among older adults, but it can have serious consequences. Suicide rates in the elderly are still higher than in younger adults and are more closely associated with depression. The devastating consequences of late-life depression are an important public health problem. The risk factors leading to the development of late-life depression comprise complex interactions among genetic vulnerabilities, cognitive diathesis, age-associated neurobiological changes, as well as stressful events.


Late-life depression is associated with an increased risk of dementia, and late-life depression may be an early manifestation of dementia rather than an increased risk for dementia. Many longitudinal studies conducted on large populations have shown that depression is associated with an increased risk of cognitive decline, mild cognitive impairment, dementia, and

Alzheimer’s disease (AD)1-10.

The correlation between Depression, Anxiety, Stress, Insomnia, Dementia, and cardiovascular profile has important implications for understanding the underlying biology and for providing information for the early identification of dementia 7-11 Keeping the above facts in mind the present study will be conducted among the elderly population attending Burdwan Medical College and Hospital so that early cognitive impairment and mental health problems and consequences can be recognized and possible remedial measures can be intervened.

Aims: To determine the effect of Stress management on Depression, Anxiety, Stress, Insomnia, and Dementia in the elderly population attending Burdwan Medical College.

Objectives:

1.      To assess and compare Depression, Anxiety, and Stress levels using the Depression, Anxiety, Stress, Insomnia severity index, and Dementia scores among the elderly male and female population attending Burdwan Medical College.

2.      To compare the Cardiovascular profile of the elderly population attending Burdwan Medical College with different levels of Depression, Anxiety, Stress, Insomnia severity index, and Dementia scale scores.

3.      To correlate Dementia levels with Depression, Anxiety, Stress, and Insomnia Severity Index scores among the elderly population attending Burdwan Medical College.

4.      To assess the impact of the stress management program on Depression, Anxiety, and Stress, Insomnia severity index, Depression levels, and cardiovascular profile of the elderly population attending Burdwan Medical College.

 

Review of literature:

Aging may decrease the ability to handle stress. Untreated, chronic stress accelerates many of the degenerative changes correlated with aging, including cognitive decline. Stress management programs may counterbalance many aspects of the stress response and protect the brain specifically from the ravages of aging combined with stress overload1-4.

Stress may injure hippocampal cells via the release of cortisol from the adrenal gland in response to hypothalamic and pituitary stimulatory signals. Such injury may result in dysfunction and atrophy of important brain structures responsible for memory and emotion1-5.

Dementia is a clinical syndrome characterized by progressive impairments of cognitive skills and the ability to function independently. Many assessment scales for dementia have been developed over the decades. Ideal scales used in dementia need to demonstrate face validity and concurrent validity against gold-standard assessments. They should be reliable, practical, and rely on objective information1-6.

A review by Khalsa DS highlighted that Kirtan Kriya (KK), is an easy, cost-effective meditation technique that can be successfully employed to improve memory in people with subjective cognitive decline and mild cognitive impairment. KK has also been shown in different studies to improve sleep and decrease depression and anxiety. It also downregulates inflammatory genes and upregulates immune system genes. Improvement in insulin and glucose regulatory genes and increased telomerase have also been observed in individuals


practicing KK3.

Paller KA studied the effects of mindfulness training among patients with cognitive impairment and their caregivers. Weekly group sessions were arranged over 8 weeks. Analysis of results showed that there were increased quality-of-life ratings, fewer depressive symptoms, and better subjective sleep quality among all participants following the intervention8.

Materials and Methods: This longitudinal study will be conducted in a three-year span of three years after taking institutional ethical clearance and informed consent of the participants. Inclusion criteria: Males and females above the age of 60 with a minimum educational level of 12th standard of education attending the Medicine outpatient department of Burdwan Medical College will be included.

Exclusion criteria:

1.      Subjects having severe cognitive impairment.

 

Sampling procedure and sample size calculation: Participants will be recruited randomly (using random numbers generated with an online randomizer) for the study from the Medicine Outpatient Department. Nearly 600 elderly patients with the 12th standard minimum education level attend the Medicine OPD in a month. As per the Population Census 2011, SRS Report 2013 proportion of the elderly population is 8.6%. Taking these figures into consideration sample size was calculated using an online sample size calculator available at calculator.net, Confidence level of 95% a margin of error 5%. The calculated sample size came to 101. Considering dropouts, 110 participants will be included in the present study.

History will be taken, followed by a general physical examination. Body mass index and Waist/Hip ratio will be calculated. A Mini-Mental State examination (MMSE) will be done for screening and excluding subjects with severe cognitive impairment; a validated questionnaire will be used for this purpose. MRI will be done for participants who need it. will be asked to fill up three scales on the first appointment, and scores will be calculated.

1.      Depression, Anxiety and Stress Scale -21 Items (DASS-21)11: The Depression, Anxiety and Stress Scale -21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress.

2.      Insomnia Severity Index (ISI): The ISI consists of 7 questions concerning sleep. The total score ranges from 0 to 28. Higher ISI scores indicate higher chances of insomnia and more severe insomnia. 9-10

3.      Revised Hasegawa’s dementia scale (HDS-R), consisting of 9 simple questions with a maximum score of 30.2

ECG will be conducted. The following blood tests will be done: Serum Cortisol, FBS, PPBS, and Lipid Profile in the Department of Biochemistry of Burdwan Medical College.

Participants will be provided feedback regarding their physical and mental health, and counseling will be done regarding the importance of taking care of one’s mental health with the advancement of age. Participants will be encouraged to take up any stress relaxation program; support will be provided to them by the Department of Physiology of Burdwan Medical College.

Stress management program support that will be provided:

a.  Progressive Muscle relaxation:


Participants will be followed up every week, either physically or virtually, for the first three months during the implementation of the stress management program and thereafter monthly. Every six months, blood tests and ECGs will be repeated, and the three-scale scores will be reassessed. All participants will be examined four 4 times in a span of two years.

Data will be collected, and appropriate statistical tests will be applied. SPSS version 16 will be used to analyze the data.

References:

1.      Lupien SJ, McEwen BS, Gunnar MR, Heim C. Effects of stress throughout the lifespan on the brain, behavior and cognition. Natl Rev Neurosci. 2009: 10: 434-45.

2.      Sheehan B. Assessment scales in dementia. Ther Adv Neurol Disord 2012; 5(6): 349– 58.

3.      Khalsaa DS, Ashford JW. Stress, Meditation, and Alzheimer’s Disease Prevention: Where The Evidence Stands. J Alzheimers Dis. 2015; 48(1): 1–12.

4.      Silva-Costa A, Griep RH, Rotenberg L. Associations of a short sleep duration, insufficient sleep, and sleep disturbances with self-rated health among nurses. PLoS One. 2015;10(5): e0126844.

5.      Yazdi Z. Sleep quality and sleep disturbances in nurses with different circadian chronotypes: Morningness and eveningness orientation. Work. 2014; 47: 561–7.

6.      Cohen, S., Kamarck, T., andMermelstein, R. (1983). A global measure of perceived stress. J. Health Soc. Behav. 24, 386–396.

7.      Pappaa S, Ntellac V, Giannakasc T, Giannakoulisc VG, Papoutsic E, Katsaounouc P. Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19 pandemic: A systematic review and meta-analysis. Brain, Behavior, and Immunity. 2020; 88: 901–907.

8.      Paller KA, Creery JD, Florczak SM, Weintraub S, Mesulam MM, Reber PJ. Benefits of Mindfulness Training for Patients with Progressive Cognitive Decline and their Caregivers. J Alzheimers Dis Other Demen. 2015; 30(3): 257–67

 

9.      Veqar, Z., and Hussain, M. E. (2020). Validity and reliability of insomnia severity index and its correlation with pittsburgh sleep quality index in poor sleepers among Indian university students. Int. J. Adolesc. Med. Health 32. doi: 10.1515/ijamh-2016- 0090.

10.  Chatterjee SS, Chakrabarty M, Banerjee D, Grover S, Chatterjee SS, Dan U (2021) Stress, Sleep and Psychological Impact in Healthcare Workers During the Early Phase of COVID-19 in India: A Factor Analysis. Front. Psychol. 2021; 12:611314. doi: 10.3389/fpsyg.2021.611314.

11.  Beaufort IN, Weert-Van Oene GHD, Buwalda VAJ, Leeuw JRJD, Goudriaan AE. The Depression, Anxiety and Stress Scale (DASS-21) as a Screener for Depression in Substance Use Disorder Inpatients: A Pilot StudyEur Addict Res 2017;23: 260–68.

 
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