NCT02598024

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

October 30, 2015

Last Update Submit

November 7, 2015

Conditions

Post-traumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • WHO Disability Assessment Schedule (WHODAS 2)

    Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)

  • Hopkins Symptom Checklist (HSCL-25)

    Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)

Study Arms (3)

Narrative Exposure Therapy (NET-R)

EXPERIMENTAL

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

Behavioral: Narrative Exposure Therapy

Control Focused Behavioural Treatment

EXPERIMENTAL

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.

Behavioral: Control Focused Behavioural Treatment

Waiting List Control

NO INTERVENTION

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

Interventions

Narrative Exposure TherapyBEHAVIORAL

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.

Narrative Exposure Therapy (NET-R)
Control Focused Behavioural TreatmentBEHAVIORAL

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.

Control Focused Behavioural Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepalese Psychological Association

Ki̇̄rtipur, Kathmandu, Nepal

Location

Related Publications (3)

  • 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.

    PMID: 10211154BACKGROUND

  • 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.

    PMID: 16281190RESULT

  • 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.

    PMID: 23363689RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Arun K Jha, FRCPsych

    Hertfordshire Partnership University NHS Foundation Trust, UK

    STUDY DIRECTOR

  • Sabitri Sthapit, PhD

    Nepalese Psychological Society

    STUDY CHAIR

Central Study Contacts

Suraj Shakya, MA

CONTACT

+977 1 4281529surajshakya2002@yahoo.com

Arun Jha, FRCPsych

CONTACT

+44-1442-215060arunjhauk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 5, 2015

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

NE(1)