Clinical trial NCT02598024: Treating Earthquake in Nepal Trauma (TENT) Trial 2016
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Lead sponsor: Nepalese Psychological Association
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline Symptom severity of PTSD as measured by PCL-5
timeFrame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Secondary outcomes:
measure: WHO Disability Assessment Schedule (WHODAS 2)
timeFrame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
measure: Hopkins Symptom Checklist (HSCL-25)
timeFrame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Other outcomes:
Locations:
city: Kirtipur
country: Nepal
facility: Nepalese Psychological Association
state: Kathmandu
Study officials:
affiliation: Hertfordshire Partnership University NHS Foundation Trust, UK
name: Arun K Jha, FRCPsych
role: STUDY_DIRECTOR
affiliation: Nepalese Psychological Society
name: Sabitri Sthapit, PhD
role: STUDY_CHAIR
References:
citation: Prigerson HG, Shear MK, Jacobs SC, Reynolds CF 3rd, Maciejewski PK, Davidson JR, Rosenheck R, Pilkonis PA, Wortman CB, Williams JB, Widiger TA, Frank E, Kupfer DJ, Zisook S. Consensus criteria for traumatic grief. A preliminary empirical test. Br J Psychiatry. 1999 Jan;174:67-73. doi: 10.1192/bjp.174.1.67.
citation: Basoglu M, Salcioglu E, Livanou M, Kalender D, Acar G. Single-session behavioral treatment of earthquake-related posttraumatic stress disorder: a randomized waiting list controlled trial. J Trauma Stress. 2005 Feb;18(1):1-11. doi: 10.1002/jts.20011.
citation: Zang Y, Hunt N, Cox T. A randomised controlled pilot study: the effectiveness of narrative exposure therapy with adult survivors of the Sichuan earthquake. BMC Psychiatry. 2013 Jan 31;13:41. doi: 10.1186/1471-244X-13-41.