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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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17 November 2015 |
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Main ID: |
NCT02598024 |
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Date of registration:
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30/10/2015 |
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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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Treating Earthquake in Nepal Trauma (TENT) Trial 2016
TENT2016 |
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Scientific title:
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The Effectiveness of 4-session Narrative Exposure Therapy and 2-session Group Control-focused Behavioural Treatment on PTSD in Nepal Earthquake Survivors After 12 Months: Study Protocol for the Randomised Waiting-list Controlled Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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240 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02598024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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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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Suraj Shakya, MA |
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Address:
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Telephone:
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+977 1 4281529 |
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Email:
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surajshakya2002@yahoo.com |
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Affiliation:
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Name:
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Arun K Jha, FRCPsych |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hertfordshire Partnership University NHS Foundation Trust, UK |
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Name:
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Sabitri Sthapit, 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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Nepalese Psychological Society |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 and over
- Must have a diagnosis of PTSD according to DSM-5 criteria with a
Clinically-Administered PTSD Scale (CAPS-5); during the screening, participants will
be asked to report on traumatic events that fulfil DSM-5 criterion 'A'.
- The PTSD symptoms must be a result of the Nepal earthquake in April 2015
Exclusion Criteria:
- High suicidality (Yes to the question "Have you recently had thoughts of ending your
life and made any plans to this effect?)
- People with severe degree of prolonged grief (Grief Score of 25 or more on the Grief
Assessment Scale, adapted from Prigerson et al., 1999)
- Severe intellectual impairment, being unable to communicate and dependent on others
for daily living (i.e. suffering from severe Learning disability)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post-traumatic Stress Disorder (PTSD)
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Intervention(s)
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Behavioral: Control Focused Behavioural Treatment
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Behavioral: Narrative Exposure Therapy
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Primary Outcome(s)
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Change from Baseline Symptom severity of PTSD as measured by PCL-5
[Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)]
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Secondary Outcome(s)
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WHO Disability Assessment Schedule (WHODAS 2)
[Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)]
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Hopkins Symptom Checklist (HSCL-25)
[Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)]
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Secondary ID(s)
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NPA/2/2015
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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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