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CTRI Number  CTRI/2018/02/011688 [Registered on: 05/02/2018] Trial Registered Retrospectively
Last Modified On: 04/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of a disaster preparedness intervention for earthquake affected communities in Nepal 
Scientific Title of Study   Enhancing Community Resilience in the Acute Aftermath of Disaster: Evaluation of a Disaster Mental Health Intervention 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Courtney Welton Mitchell and Leah James 
Designation  Research Associates 
Affiliation  University of Colorado Boulder 
Address  Natural Hazards Center Institute of Behavioral Science University of Colorado-Boulder 1440 15th St Boulder CO 80309, USA



80309
Other 
Phone  3034928147  
Fax    
Email  CourtneyMitchell13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Courtney Welton Mitchell and Leah James 
Designation  Research Associates 
Affiliation  University of Colorado Boulder 
Address  Natural Hazards Center Institute of Behavioral Science University of Colorado-Boulder 1440 15th St Boulder CO 80309, USA



80309
Other 
Phone  3034928147  
Fax    
Email  CourtneyMitchell13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Courtney Welton Mitchell and Leah James 
Designation  Research Associates 
Affiliation  University of Colorado Boulder 
Address  Natural Hazards Center Institute of Behavioral Science University of Colorado-Boulder 1440 15th St Boulder CO 80309, USA
Natural Hazards Center Institute of Behavioral Science University of Colorado-Boulder 1440 15th St Boulder CO 80309 USA


80309
Other 
Phone  3034928147  
Fax    
Email  CourtneyMitchell13@gmail.com  
 
Source of Monetary or Material Support  
ELRHA R2HC Research for Health in Humanitarian Crisis Contributions to ELRHA R2HC are largely from DFID and Wellcome Trust; Save the Children Wales / Achub y Plant Cymru 8 Cathedral Rd, Cardiff CF1 9LJ 
 
Primary Sponsor  
Name  Institute of Behavioral Science University of ColoradoBoulder 
Address  1440 15th St Boulder CO 80309 USA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Courtney Welton Mitchell  Bhaktapur Nepal  Community Hall in Changunarayan Municipality Ward no. 2 Chhaling area and Community Hall in Mahamanjushree Municipality ward no. 3 Tathali Sudol area

 		 3034928147

CourtneyMitchell13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CU IRB (Boulder, Colorado, USA), NHRC (Kathmandu, Nepal) and SWC (Kathmandu, Nepal)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The primary condition/problem studied is disaster preparedness and mental health (with a focus on symptoms of depression and PTSD). 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3-day workshop  Community-based disaster mental health intervention (CBDMHI) vs. waitlist control (administered first to all participants in one cluster then a few weeks later to all participants in the next cluster). 
Comparator Agent  waitlist control  Community-based disaster mental health intervention (CBDMHI) vs. waitlist control (administered first to all participants in one cluster then a few weeks later to all participants in the next cluster). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  age 18-65; available to attend 3-day intervention training; able to understand consent procedures; resident of community and present in community during earthquakes in April and May 2015.  
 
ExclusionCriteria 
Details  unable to attend the 3-day intervention training; unable to understand consent procedures 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant differences in the following primary outcomes at Time 2 (2 weeks after the intervention) between the group that received the intervention and the one that had not yet received the intervention:
Disaster preparedness
Depression symptoms
PTSD symptoms
Social cohesion
 		 3 time points (baseline, 2 weeks post intervention, 4 weeks post intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Significant differences in the following secondary outcomes at Time 2 (2 weeks post intervention) between the group that received the intervention and the one that had not yet received the intervention:
Help-seeking – mental health related
Help-giving – mental health related
Help-seeking – disaster preparation related
Help-giving – disaster preparation related 		 3 time points (baseline, 2 weeks after the intervention and 4 weeks after the intervention) 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/07/2015 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   We developed and tested a hybrid mental health - disaster preparedness intervention in two earthquake affected communities in Nepal (N = 240) in the aftermath of the Nepal earthquake. The 3-day intervention was culturally adapted, facilitated by trained laypersons and junior clinicians and focused on enhancing community resilience. Communities were selected based on earthquake impacts and matched on demographic variables.The intervention was administered initially to one randomly selected community of the two, followed by the other receiving the intervention shortly thereafter. Date was collected across three time points a few months after the earthquake to examine the primary outcomes of disaster preparedness, mental health symptoms, and social cohesion.  
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