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CTRI Number  CTRI/2024/11/076615 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Understanding utility of a program (ReachOut) to reduce hesitations to seek help for common mental health concerns 
Scientific Title of Study   Examining efficacy of ReachOut intervention for improving help seeking- A 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  Dr Seema Mehrotra 
Designation  Professor 
Affiliation  NIMHANS 
Address  Dept of Clinical Psychology Govindaswamy center,National Institute of Mental Health and Neuro Sciences, NIMHANS Bangaluru,560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9448503853  
Fax    
Email  seema@nimhans.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Mehrotra 
Designation  Professor 
Affiliation  NIMHANS 
Address  Dept of Clinical Psychology Govindaswamy center,National Institute of Mental Health and Neuro Sciences, NIMHANS Bangaluru,560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9448503853  
Fax    
Email  seema@nimhans.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Seema Mehrotra 
Designation  Professor 
Affiliation  NIMHANS 
Address  Dept of Clinical Psychology Govindaswamy center,National Institute of Mental Health and Neuro Sciences, NIMHANS Bangaluru,560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9448503853  
Fax    
Email  seema@nimhans.ac.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Dr Seema Mehrotra 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, NIMHANS, 560029 
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 
Dr Seema Mehrotra  National Institute of Mental Health and Neurosciences  Room No. 323, Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, 560029
Bangalore
KARNATAKA 		 9448503853

seema@nimhans.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Behavioural Science Division), NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Recruited participants will be those with distress but have not received a psychiatric diagnosis. They may or may not have depression and/or anxiety disorder. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  First component /module of the REACH OUT intervention  Participants allocated to this group will only receive the first component /module of the REACH OUT intervention , i.e. personalized feedback based on their baseline survey responses. Help seeking inclination and behaviour will be assessed at pre planned intervals during the 7-week period as mentioned for the intervention group. 
Intervention  ReachOut intervention  Reach Out group will receive all the components of the intervention over a 7-week period. Help seeking inclination and behaviour (primary outcomes) will be assessed with 2 items at pre planned intervals during this 7-week period (at the end of week 1 after module 1 (personalized feedback) , End of week 3 and End of Week 6 ( after 6th module). 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  18 to 35 years;Comfort with using smartphone app;Able to speak /read/write English or Kannada/Hindi;10 years or more of formal education;Self-report of depressive or anxiety symptoms for at least 2 weeks
;Scoring above cut off on a standardized measure of distress (K-10) 
 
ExclusionCriteria 
Details  Not amenable to participate in the study as assessed in the brief telephonic interview;Currently receiving medical treatment for any mental health condition; Having undergone 3 or more than 3 psychotherapy/counselling sessions for a mental health
concern in the last 3 months/currently seeking counselling/psychotherapy services 
 
Method of Generating Random Sequence   Other 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Help seeking behaviour from a professional  Baseline, 8th week (or upon occurrence of help seeking behaviour whichever is earlier), Follow up-I 1 month after post assessment ( 12th week) and Follow up -II 2 months after post assessment (16th week) 
 
Secondary Outcome  
Outcome  TimePoints 
Barriers to help seeking from professionals  1.Baseline
2. Post assessment- End of 7th week (or upon occurrence of help seeking behaviour 
 
Target Sample Size   Total Sample Size="318"
Sample Size from India="318" 
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)   28/11/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
ReachOut has been developed and pilot tested as a WhatsApp based intervention to improve
help seeking for common mental health problems in non-treatment seeking urban Indian young
adults .(Sanghvi, Mehrotra, Sharma, 2023). The present study is a randomized controlled trial
of this intervention in college going young adults.
It is well known that young adults exhibit high rates of significant distress and common

mental health problems and various barriers to help seeking such as high preference for self-
reliance, help negation or preference for informal peer support. (Mitchell, McMillan, & Hagan,

2017; Eigenhuis et.al., 2021). Sanghvi, Mehrotra, 2021; Sanghvi, Mehrotra, Sharma, 2022).
Technology-based interventions show promise in improving help-seeking inclination and
behaviours ( Johnson, Sanhgvi & Mehrotra, 2022).
ReachOut intervention involves weekly delivery of multiple components of intervention to
improve help seeking over a period of 7 weeks and includes WhatsApp-delivered materials
as well as two phone calls (for motivation-enhancement and support-mobilization from
significant other). (Sanghvi,Mehrotra,Sharma,2023) In a pilot trial, it was found to be
effective, reducing self-perceived barriers and improving help seeking inclination and behavior
in a sample of distressed young adults in the community. This study utilized a single group
prospective design. This pilot work also demonstrated that the intervention was feasible and
acceptable and had scalability potential. The present study aims to check the effectiveness of ReachOut interventions in distressed, non-treatment-seeking young adults in institutes of higher education as compared to active controls. The study design involves a two-arm comparison group design. The intervention group will receive the whole ReachOut package and  active control would receive personalized feedback (the first component of ReachOut). The expected outcome of the study is that ReachOut intervention will improve help-seeking behaviour. 
 
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