Treating Earthquake in Nepal Trauma (TENT) Trial 2016

Not Applicable

• Conditions: Post-traumatic Stress Disorder (PTSD)

• Registration Number: NCT02598024
• Lead Sponsor: Nepalese Psychological Association

Brief Summary

The purpose of this study is to determine whether two types of short-term trauma-focused therapies (individual Narrative Exposure Therapy and group-based Control-Focused Behavioural Treatment) are effective in the treatment of chronic PTSD in earthquake survivors of Nepal.

Detailed Description

Background: Post-traumatic stress disorder (PTSD) is a common mental health disorder after natural disasters. Without treatment survivors of earthquake would continue suffering from PTSD for many years. There are not many short-term trauma-focused psychosocial therapies that have been examined after natural disasters in developing countries. This study investigates the effectiveness of a 4-session revised narrative exposure therapy (NET-R), and 2-session group-based control-focused behavioural treatment (CFBT-R) delivered by non-specialists with minimum supervision.

Methods/Design: Participants would be identified and recruited through a door-to-door survey of families severely affected by the 2015 earthquake in Bhaktpur municipality of Nepal. PTSD Checklist for DSM-5 (PCL-5) will be used to screen all adult survivors (aged 18 and above) for the possible presence of PTSD, and the CAPS-5 interview will be used for the diagnosis of current PTSD. Investigators aim to include 240 consenting participants in a single blind randomised controlled clinical trial. All participants will be randomly allocated to one of three treatment conditions (N = 80 each): 4-session revised narrative exposure therapy (NET-R), 2-session group-based control-focused behavioural treatment (CFBT-R) involving instructions to conduct self-exposure, or a 3-month waiting list. In both NET-R and CFBT-R interventions, treatment sessions will last 90 minutes; NET-R will be delivered within a week while CFBT-R will be done over 2 weeks. All participants will be subjected to blind assessments for PTSD symptom severity with CAPS-5 and Fear and Avoidance questionnaire at pre-treatment (T0) and 3-month post-treatment (T1).

Discussion: The results from the post-treatment measurement would provide strong empirical reference of the safety and effectiveness of trauma-focused short-term therapies (NET-R and CFBT-R) for mass trauma survivors in developing countries like Nepal. It may also provide information on who may benefit most from which type of intervention.

Study Timeline

• Study First Submitted: 2015-10-30
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Submitted: 2015-11-07
• Last Update Posted: 2015-11-10
• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline Symptom severity of PTSD as measured by PCL-5	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	The PTSD Checklist for DSM-5 (PCL-5; Weathers et al, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing up the scores for each of the 20 items. The VA National Centre for PTSD has suggested a cut off score of 38 to screen for PTSD.

Secondary Outcome Measures

Name	Time	Method
WHO Disability Assessment Schedule (WHODAS 2)	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	WHODAS 2 measures disability related to a health condition.
Hopkins Symptom Checklist (HSCL-25)	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	HSCL is a 25-item instrument to measure depression using DSM-IV criteria.

Trial Locations

Locations (1)

Nepalese Psychological Association; 🇳🇵 Kirtipur, Kathmandu, Nepal