FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065769 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Psychosocial intervention for sub-clinical Common Psychological Problems-a a multi-centric study from Central India 
Scientific Title of Study   Randomized Controlled Trial to Assess the Feasibility of Delivering Psycho-Social Interventions and Effectiveness in Improving the Common Psychological Problems of the Non-Clinical Population: a multi-centric and multi-setting study from central India 
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 Snehil Gupta 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Dept. of Psychiatry, room no 3002, 3rd floor academic block, All India Institute of Medical Sciences, Bhopal-462020

Bhopal
MADHYA PRADESH
462020
India 
Phone  9582068628  
Fax    
Email  snehil.psy@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Pakhre 
Designation  Assistant professor  
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Dept. of Psychiatry, room no-3004, 3rd floor, academic block, AIIMS Bhopal,Saket nagar-462020

Bhopal
MADHYA PRADESH
462020
India 
Phone  9871891011  
Fax    
Email  Sjmc.Ashish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Pakhre 
Designation  Assistant professor (Psychiatry) 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Dept of psychiatry, room no 3004, 3rd floor academic block, AIIMS Bhopal, Saket nagar-462020

Bhopal
MADHYA PRADESH
462020
India 
Phone  9871891011  
Fax    
Email  Sjmc.Ashish@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V.Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Snehil Gupta  AIIMS Bhopal  Dr. Snehil Gupta, Dept of Psychiatry, room no-3002, 3rd floor academic block, AIIMS Bhopal, Saket Nagar- 462020
Bhopal
MADHYA PRADESH 		 9582068628

snehil.psy@aiimsbhopal.edu.in 
Dr Amit Singh  King Georges Medical University (KGMU)  Dr. Amit Singh, Dept of psychiatry, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 8853817280

amitsingh0612@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Human Ethics Committee (IHEC))  Approved 
Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  sub-syndromic anxiety, depression, & stress-related mental healht conditions. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comprehensive wellness intervention package (comprehensive wellness program for mental health-"COMeWELL with PRiMEHElp”)  Intervention arm (to be delivered over 3wks): Wellness program package (diet, exercise, counseling about the menstrual care for females, motivation to quit substance or stay away from the substance, relaxation exercises, stress-management, behavioral activation, coping skill training, group support through) including training within the sessions and providing the wellness videos available in the public domains. It would have one-two general sessions common for all the groups of problems (depression, anxiety, stress, somatic problems) followed by tailored individualized care in one session. Besides, information on where to access care, about their medical conditions, including sub syndromic psychological problems shall also be provided. The intervention shall be delivered by the research staff who are trained psychologists with M.Phill degree in clinical psychology/MA in psychology. 
Comparator Agent  General health education  general education ( to be delivered over 3 weeks )about a healthy life, counseling on the diet, exercise, maintaining good social support. Likewise of the intervention arm, information on where to access care, about their medical conditions, including sub syndromic psychological problems shall also be provided. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  I. Age: above 18years. II. Resides in the catchment
area of the Primary Health Centre OR able to follow-up in the hospital regularly III. Individuals
visiting: the Primary Health Centre OR screening out-screening out-patient dept (of its equivalent)
in the tertiary care hospital OR family members (up to three-degree relatives)/acquaintances of the 
 
ExclusionCriteria 
Details  I. Suffering from a severe medical illness (uncontrolled Diabetes, hypertension, COPD/asthma, etc.)
Sub-syndromic psychotic or manic symptoms, or other severe mental illnesses.

II. Diagnosed to be a case of mental disorder (as assessed on structured instruments (Structured Clinical Interview for DSM-5 Disorders, Clinical Trials Version (SCID-CT).

III. Already receiving any kind of treatment (pharmacological or non-pharmacological) from the mental health professionals for their sub-syndromic mental health problems.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the scores on the DASS-21 (anxiety, depression, and stress), SSS-8 (somatic symptoms), and WHO-QoL-BREF (total as well as domain-specific) from baseline to end-of-session, 1months, and 3months post-intervention.  at baseline (0 month), to end-of-session (3wks+/-1wk), 1months (1month 3wks+/-1wk), and 3months (3 months 3wks+/-1wk) post-intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
feasibility (acceptibility, reproducibility, demand, limited efficacy testing)  0, 1, 3months 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   01/10/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [SNEHIL.PSY@AIIMSBHOPAL.EDU.IN].

  6. For how long will this data be available start date provided 30-09-2026 and end date provided 29-09-2029?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The study is aimed at assessing the feasibility and effectiveness of delivering wellness intervention for the non-clinical population who harbour sub-syndromal anxiety or depression or stress-related problems and are availing services for other medical disorders in different departments of the tertiary care hospital setting or community setting. A comprehensive wellness intervention package (comprehensive wellness program for mental health-"COMeWELL with PRiMEHElp”) shall be delivered by a trained psychologist to the intervention group while a general health advice shall be provided to the control arm and their effectiveness would be assessed over a period of three months. It would be a multi-site study. The intervention would be developed first and then be validated before employing in the study as per the standard guidelines. At the end of the study, we would like to evaluate the effectiveness of the  COMeWELL with PRiMEHElp interventions Vis-a-vis general education. We will also assess the feasibility of delivering such an intervention in different settings.

 
Close