| CTRI Number |
CTRI/2018/02/012002 [Registered on: 20/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Disaster mental health in Nepal and Haiti |
|
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 WeltonMitchell PhD |
| Designation |
Principal Investigator |
| Affiliation |
Natural Hazards Center, Institute of Behavioral Science, 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 |
1-303-492-8147 |
| Fax |
|
| Email |
CourtneyMitchell13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Courtney WeltonMitchell PhD |
| Designation |
Principal Investigator |
| Affiliation |
Natural Hazards Center, Institute of Behavioral Science, 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 |
1-303-492-8147 |
| Fax |
|
| Email |
CourtneyMitchell13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Courtney WeltonMitchell PhD |
| Designation |
Principal Investigator |
| Affiliation |
Natural Hazards Center, Institute of Behavioral Science, 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 |
1-303-492-8147 |
| 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)
|
|
|
Primary Sponsor
|
| Name |
Courtney WeltonMitchell |
| Address |
Natural Hazards Center, Institute of Behavioral Science, University of Colorado, Boulder
1440 15th St, Boulder, CO 80309, USA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Haiti
Nepal |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Courtney WeltonMitchell |
Kailai District, Nepal |
1) Lalbojhi, 2) Dhansinghpur and 3) Tikapur Municipality (Wards 1 & 2), Kailali District, Nepal
|
977-01-4431717
CourtneyMitchell13@gmail.com |
| Courtney WeltonMitchell |
Metropolitan Port-au-Prince, Haiti |
1)Bon Repos; 2) Cite Soleil; 3) Carrefour, Port-au-Prince, Haiti
|
509-46357609
CourtneyMitchell13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ensitey Travay Sosyal ak Syens Sosyal |
Approved |
| Nepal Health Research Council (NHRC) |
Approved |
| University of Colorado IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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, PTSD, and anxiety). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community-based disaster mental health intervention (CBDMHI) |
Three-day group intervention designed to increase disaster preparedness and decrease mental health problems. |
| Comparator Agent |
Waitlist control group |
Wait-list control group received no intervention during project duration but did receive CHMHI intervention at project end. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Available to attend 3-day intervention training; able to understand consent procedures; resident of community and present in community during recent hurricane/monsoon season. |
|
| 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
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hypothesized significant differences in the following primary outcomes at Time 2 and persisting to Time 3 between intervention and control groups:
Disaster preparedness
Depression symptoms
PTSD symptoms
Anxiety symptoms, in Haiti only
Culturally bound symptoms
Functional impairment
Social cohesion |
baseline, 6 months later, 9 months later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Help seeking mental health related
Help giving mental health related
Help seeking disaster preparation related
Help giving disaster preparation related
Coping
Disaster attributions e.g., to natural or supernatural causes
Fatalism |
baseline, 6 months later, 9 months later |
|
|
Target Sample Size
|
Total Sample Size="960"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2014 |
| 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) |
Closed to Recruitment of Participants |
|
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 and disaster preparedness intervention in chronically flood-affected communities in Nepal (n = 480 households) and Haiti (n = 480 households). The 3-day intervention was culturally adapted, facilitated by trained laypersons and junior clinicians and focused on enhancing community resilience. Three communities in each country were selected based on disaster impacts. Participants in each community were randomized to intervention or to wait-list control conditions. Interventions were scheduled to occur prior to monsoon/hurricane season in each context. Interview data was collected across three time-points: 1) baseline/pre-intervention; 2) post-intervention; and 3) follow-up, to examine intervention effects on outcomes, including disaster preparedness, mental health symptoms and social cohesion. |