Treating Earthquake in Nepal Trauma (TENT) Trial 2016

Post-traumatic Stress Disorder (PTSD) Clinical Trial

— TENT2016  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02598024
• Other study ID #: NPA/2/2015
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2015
• Last updated: November 7, 2015
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: Nepalese Psychological Association
• Contact: Suraj Shakya, MA
• Phone: +977 1 4281529
• Email: surajshakya2002[@]yahoo.com
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Narrative Exposure Therapy
In Narrative Exposure Therapy the patient constructs a narration of his or her life, focusing on the detailed context of the traumatic experiences as well as on the important elements of the emotional networks and how they go together. This process allows the majority of persons to recognise that the fear/trauma structure results from past experiences and that its activation is just a memory. They thus lose the emotional response to the recollection of the traumatic events, which consequently leads to a remission of PTSD symptoms. Thus, they gain access to 'lost' past memories and develop a sense of coherence, control, and integration. Revised Narrative Exposure Therapy (NET-R, Zang et al, 2013) is a 4-session treatment delivered within a week.
• Control Focused Behavioural Treatment
The Control-focused Behavioural Treatment (CFBT, Basoglu et al 2005) for earthquake survivors was designed after 1999 Turkey earthquake as an intervention to facilitate natural recovery processes by restoring sense of control over anxiety, fear, or distress. Its underlying principle is to reduce helplessness responses by encouraging behaviours that are likely to enhance sense of control over stressor events and life in general. Its primary aim is to reverse traumatic stress processes by increasing anxiety or distress tolerance. In earthquake survivors, CFBT involves a single session in most cases and an additional few sessions in cases that do not respond to the initial session.

Locations

Country	Name	City	State
Nepal	Nepalese Psychological Association	Kirtipur	Kathmandu

Sponsors (1)

Lead Sponsor	Collaborator
Nepalese Psychological Association

Country where clinical trial is conducted

Nepal, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Symptom severity of PTSD as measured by PCL-5	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.	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	No
Secondary	WHO Disability Assessment Schedule (WHODAS 2)	WHODAS 2 measures disability related to a health condition.	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	No
Secondary	Hopkins Symptom Checklist (HSCL-25)	HSCL is a 25-item instrument to measure depression using DSM-IV criteria.	Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)	No