Post-traumatic Stress Disorder (PTSD) Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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