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CTRI Number  CTRI/2025/11/096929 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Single Arm Study 
Public Title of Study   Multicomponent lifestyle intervention program for individuals with major depressive disorder 
Scientific Title of Study   Adaptation and testing the acceptability and feasibility of a multicomponent lifestyle intervention program for first episode major depressive disorder: A mixed methods study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Virtu Chongtham 
Designation  PhD Scholar  
Affiliation  Department of Nursing , Chitkara School of Health Sciences  
Address  Department of Nursing Chitkara School of Health Sciences Chitkara University, Punjab
Chitkara University Chandigarh-Patiala National Highway Rajpura, Punjab
Patiala
PUNJAB
140401
India 
Phone  9646786334  
Fax    
Email  virtu05gmch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harmeet Kaur Kang 
Designation  Director and Principal 
Affiliation  Department of Nursing , Chitkara School of Health Sciences  
Address  Department of Nursing Chitkara School of Health Sciences Chitkara University, Punjab
Chitkara University Chandigarh-Patiala National Highway Rajpura, Punjab
Patiala
PUNJAB
140401
India 
Phone  09815143237  
Fax    
Email  harmeet.kaur@chitkara.edu.in  
 
Details of Contact Person
Public Query  
Name  Virtu Chongtham 
Designation  PhD Scholar  
Affiliation  Department of Nursing , Chitkara School of Health Sciences  
Address  Department of Nursing Chitkara School of Health Sciences Chitkara University, Punjab
Chitkara University Chandigarh-Patiala National Highway Rajpura, Punjab
Patiala
PUNJAB
140401
India 
Phone  9646786334  
Fax    
Email  virtu05gmch@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR 32 B, CHANDIGARH, 160030 India 
 
Primary Sponsor  
Name  Department of Psychiatry 
Address  Government Medical College and Hospital Sector 32 B, Chandigarh  
Type of Sponsor  Government medical college 
 
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 
VIRTU  Govt Medical College and Hospital Chandigarh  Department of Psychiatry OPD Services Room no 4224
Chandigarh
CHANDIGARH 		 09646786334

virtu05gmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GMCH CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multicomponent Lifestyle Intervention   Interventions components include Diet, Physical Activity, Sleep Duration- The Intervention shall be conducted in two phases: First phase will include 6 (six) individualized face to face sessions with the frequency: 0 week (baseline), 1 week, 3 week, 6 week, 9 week and 12 week over 3 months period and second phase will include will include monthly individual/group session for 1 hour over 3 months period i.e., total of 3 session focusing on maintain weight loss 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 18 to 65 years
2. Diagnosed with the first episode of major depression as per ICD-11
3. Possess a smartphone
4. Able to read and speak Hindi or English or Punjabi
5. Willingness to provide informed consent and comply with the study protocol
 
 
ExclusionCriteria 
Details  1. Subject with comorbidity of diabetes mellitus type I or II, CVD, HTN, dyslipidemia, or another serious medical and neurocognitive disorder (which may interfere with adherence of the lifestyle interventions); and use of medication that interferes with weight or thyroid medications, comorbid substance dependence except for nicotine & caffeine
2. Subjects with recurrent depressive disorder, bipolar disorder, comorbidity with acute psychosis or mania episodes, eating disorder
3. Current suicidal tendencies
4. Pregnancy
5. Current hospitalization
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome will be acceptability & feasibility of the multicomponent lifestyle intervention program in reducing depressive symptoms and improving physical activity, diet & sleep of persons with first episode major depressive disorder  3, 6 month after intervention delivered 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   20/11/2025 
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="0"
Months="8"
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: Adaptation and testing the acceptability and feasibility of a multicomponent lifestyle intervention program for first episode major depressive disorder: A mixed method study

Introduction:

Depression disorders and NCD (cardiometabolic disorders etc) are common disorders worldwide and in India too. The recently published Global Burden of Disease (2020) reports India having 197.3 million had mental disorders in 2017; of which 45.7 million suffer from depressive disorders.1 India is experiencing the burden of rising rates of non-communicable diseases. According to a WHO report, in 2015, 5.8 million die from NCD every year. WHO projects annual number of death from NCD worldwide will increase to 55 million by 2030 without timely intervention for prevention and control. Both depressive disorder and NCD often coexist and also share the same risk factors i.e., unhealthy lifestyle.2 People diagnosed with depression tend to engage in unhealthy lifestyle behaviors including poor diet, sedentary behavior, smoking, and alcohol consumption. Additionally, the use of antidepressant used may lead to central obesity, high BP as well and high triglycerides level.3

Many previous studies targeting these shared modifiable lifestyle risk factors like physical activity, diet, sleep, etc have been reported in context to prevention and management of cardiometabolic disorders among persons diagnosed with mental disorders including depressive disorder from high-income countries but such pieces of evidence are lacking from low- and middle-income countries including India.4 Recently, there has been a growing evidence base that supports the efficacy & cost-effectiveness of lifestyle-based interventions in the prevention and management of mental health disorders.5

However, many of these lifestyle-based intervention studies have focused on specific healthy components rather than multi-component lifestyle intervention programs which provide greater health benefits and are cost-effective.6

 

 Additionally, to the best of my knowledge, no study has been conducted so far in Indian setting for testing the acceptability & feasibility of a culturally adapted multicomponent lifestyle intervention provided from the initial or first episode of major depressive disorder for dual benefit in reducing the symptoms as well as ensuring adoption of healthy lifestyle interventions.

 

 

 

 

Objectives:

Obj 1: To adapt evidence- based lifestyle interventions to reduce depressive symptoms and improve physical activity, diet & sleep among persons with first episode major depressive disorder  

Obj 2: To assess the acceptability and feasibility of the multicomponent lifestyle intervention program among persons with first episode major depressive disorder

Population to be studied: First episode major depressive disorder attending Psychiatric OPD

Intervention: Multicomponent Lifestyle Intervention Program

Study Design: Intervention Mapping & single group feasibility study

Study setting: Psychiatry Out patient Services (OPD), Department of Psychiatry, Govt Medical College & Hospital, Chandigarh

Study period: 3 years

Subject Recruitment: Prospective

Target sample size: 36

Outcome of the study: The outcome will be acceptability & feasibility of the multicomponent lifestyle intervention program in reducing depressive symptoms and improving physical activity, diet & sleep of persons with first episode major depressive disorder.

References:

1. India State-Level Disease Burden Initiative Mental Disorders Collaborators. The burden of mental disorders across the states of India: the Global Burden of Disease Study 1990-2017. Lancet Psychiatry. 2020 Feb;7(2):148–61.

2. Stein DJ, Benjet C, Gureje O, Lund C, Scott KM, Poznyak V, et al. Integrating mental health with other non-communicable diseases. BMJ. 2019 Jan 28;364: 295.

3. Moradi Y, Albatineh AN, Mahmoodi H, Gheshlagh RG. The relationship between depression and risk of metabolic syndrome: a meta-analysis of observational studies. Clin Diabetes Endocrinol. 2021 Mar 2;7(1):4.

4. Firth J, Siddiqi N, Koyanagi AI, Siskind D, Rosenbaum S, Galletly C, et al. The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness. The Lancet Psychiatry. 2019;6(8):675–712.

5. Marx W, Jacka F, O’Neil A. Lifestyle-based mental health care in psychiatry: Translating evidence into practice. Aust N Z J Psychiatry. 2021 Jul;55(7):641–3.

6. Gómez-Gómez I, Motrico E, Moreno-Peral P, Rigabert A, Conejo-Cerón S, Ortega-Calvo M, et al. Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2019 Mar 15;9(3):e026842.

 
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