Post-traumatic Stress Disorder (PTSD)TENT2016NCT02598024
Treating Earthquake in Nepal Trauma (TENT) Trial 2016
A study testing Narrative Exposure Therapy in people with Post-traumatic Stress Disorder (PTSD), run by Nepalese Psychological Association at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteNepal
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Being tested
- Narrative Exposure Therapy, Control Focused Behavioural Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Secondary outcomes (2)
WHO Disability Assessment Schedule (WHODAS 2)
WHODAS 2 measures disability related to a health condition.
Measured: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Hopkins Symptom Checklist (HSCL-25)
HSCL is a 25-item instrument to measure depression using DSM-IV criteria.
Measured: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nepalese Psychological Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suraj Shakya, Nepalese Psychological Association
- Investigators
- Arun K Jha, FRCPsych, Study director, Hertfordshire Partnership University NHS Foundation Trust, UKSabitri Sthapit, PhD, Study chair, Nepalese Psychological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598024
- Sponsor's protocol ID
- NPA/2/2015
- Acronym
- TENT2016
- Status last verified
- Nov 2015
- First submitted
- 30 Oct 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 10211154Basoglu 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.
PubMed 16281190Zang 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.
PubMed 23363689
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02598024
- Acronym / sponsor ID
- TENT2016 / NPA/2/2015
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nepalese Psychological AssociationUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy (NET-R) | Experimental | Behavioral: Narrative Exposure TherapyRevised 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 |
| Control Focused Behavioural Treatment | Experimental | Behavioral: Control Focused Behavioural TreatmentCFBT 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. |
| Waiting List Control | No intervention | –The waiting list participants will receive the treatment of choice (NET-R or CBFT-R) after 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyIn 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. | Behavioural | Narrative Exposure Therapy (NET-R) |
| Control Focused Behavioural TreatmentThe 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. | Behavioural | Control Focused Behavioural Treatment |
Primary outcome
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)
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.
2 secondary outcomes
WHO Disability Assessment Schedule (WHODAS 2)
Time frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Hopkins Symptom Checklist (HSCL-25)
Time frame: Pre-treatment (T0), 2-week post-treatment (T1) and at three-month follow-up (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Background: PubMed 10211154Prigerson 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.
- Results publication: PubMed 16281190Basoglu 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.
- Results publication: PubMed 23363689Zang 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.
Related trials for Post-traumatic Stress Disorder (PTSD)
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun K Jha, FRCPsych study director
Hertfordshire Partnership University NHS Foundation Trust, UK
Sabitri Sthapit, PhD study chair
Nepalese Psychological Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy in people with Post-traumatic Stress Disorder (PTSD), run by Nepalese Psychological Association at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suraj Shakya, MA (+977 1 4281529, surajshakya2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598024, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.