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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03359486 |
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Date of registration:
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26/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal
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Scientific title:
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Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal |
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Date of first enrolment:
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December 17, 2017 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03359486 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Mark van Ommeren, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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World Health Organization |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. score >2 on General Health Questionnaire (dichotomous item scoring method)
2. score >16 on World Health Organization Disability Assessment Scale
Exclusion Criteria:
1. Presence of a severe mental disorder (e.g., psychosis)
2. Alcohol use disorder (score >16 on the alcohol use disorders identification test
(AUDIT)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Behavioral: Enhanced treatment as usual
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Behavioral: Group problem management plus
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Primary Outcome(s)
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Depression - Patient Health Questionnaire
[Time Frame: 1 week post-intervention]
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Secondary Outcome(s)
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Reducing Tension Checklist for Problem Management Plus Skills
[Time Frame: 1 week post-intervention]
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Personalized Measure of Distress - Psychological Outcome Profiles
[Time Frame: 1 week post-intervention]
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Daily functioning - World Health Organization Disability Assessment Scale
[Time Frame: 1 week post-intervention]
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Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
[Time Frame: 1 week post-intervention]
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Culture-specific general psychological distress - Nepali Psychosocial and Mental Health Problems
[Time Frame: 1 week post-intervention]
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General psychological distress - General Health Questionnaire
[Time Frame: 1 week post-intervention]
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Secondary ID(s)
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ERC.0002817
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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