- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598024
Treating Earthquake in Nepal Trauma (TENT) Trial 2016 (TENT2016)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kathmandu
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Kirtipur, Kathmandu, Nepal
- Nepalese Psychological Association
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Narrative Exposure Therapy (NET-R)
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
|
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.
|
Experimental: 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.
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The Control-focused Behavioural Treatment (CFBT, Başoğlu 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.
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No Intervention: Waiting List Control
The waiting list participants will receive the treatment of choice (NET-R or CBFT-R) after 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Symptom severity of PTSD as measured by PCL-5
Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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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.
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Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHO Disability Assessment Schedule (WHODAS 2)
Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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WHODAS 2 measures disability related to a health condition.
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Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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Hopkins Symptom Checklist (HSCL-25)
Time Frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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HSCL is a 25-item instrument to measure depression using DSM-IV criteria.
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Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
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Collaborators and Investigators
Investigators
- Study Director: Arun K Jha, FRCPsych, Hertfordshire Partnership University NHS Foundation Trust, UK
- Study Chair: Sabitri Sthapit, PhD, Nepalese Psychological Society
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPA/2/2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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