Treating Earthquake in Nepal Trauma (TENT) Trial 2016 (TENT2016)

Nepalese Psychological Association

Status: Unknown

Conditions: Post-traumatic Stress Disorder (PTSD)

Treatments: Behavioral: Control Focused Behavioural Treatment; Behavioral: Narrative Exposure Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02598024

NPA/2/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

240 participants in 3 patient groups

Narrative Exposure Therapy (NET-R)

Experimental group

Description:

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

Treatment:

Behavioral: Narrative Exposure Therapy

Control Focused Behavioural Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Control Focused Behavioural Treatment

Waiting List Control

No Intervention group

Description:

The waiting list participants will receive the treatment of choice (NET-R or CBFT-R) after 3 months.