Treating Earthquake in Nepal Trauma (TENT) Trial 2016

Not Applicable

• Conditions: Post-traumatic Stress Disorder (PTSD)
• Interventions: Behavioral: Narrative Exposure Therapy; Behavioral: Control Focused Behavioural Treatment

• 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

Arm && Interventions

Group	Intervention	Description
Narrative Exposure Therapy (NET-R)	Narrative Exposure Therapy	Revised Narrative Exposure Therapy (NET-R) is a 4-session manual-based treatment, each session lasting 60-90-minutes, and first three sessions delivered daily and the last session after a gap of 1-2 days
Control Focused Behavioural Treatment	Control Focused Behavioural Treatment	CFBT is an intervention to facilitate natural recovery process by restoring sense of control over anxiety, fear, or distress. For this study in Nepal, a monitoring session will be added to the one-session group CFBT used by Basoglu and Salcioglu (2011), and the revised CFBT would be delivered to groups of 20-30 survivors. Each treatment session would be delivered within 1- 2 hours (90 minutes on average), at the interval of two weeks.

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