| CTRI Number |
CTRI/2024/09/074294 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study whether Narrative Exposure Therapy is helpful for individuals who have been displaced from their homes due to large-scale violent conflict. |
|
Scientific Title of Study
|
Effectiveness of Narrative Exposure Therapy Among Violence Affected Internally Displaced People with Post-Traumatic Stress Disorder in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitali Mendon |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychosocial Support in Disaster Management, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
chaitali.mendon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Goyal |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychosocial Support in Disaster Management, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026972283 |
| Fax |
|
| Email |
ajaygoyal@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Chaitali Mendon |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychosocial Support in Disaster Management, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026972283 |
| Fax |
|
| Email |
chaitali.mendon@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Bengaluru- 560029, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden)
Bangalore – 560029
Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Goyal |
National Institute of Mental Health and Neurosciences |
Department of Psychosocial Support in Disaster Management, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka - 560029
Bangalore
KARNATAKA |
08026972283
ajaygoyal@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Behavioral Sciences Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F431||Post-traumatic stress disorder (PTSD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Narrative Exposure Therapy (NET) |
It is a treatment for trauma-spectrum disorders. It was specifically developed to be used in low-resource settings among survivors of complex and multiple traumas. It is based on the principles of testimony therapy, exposure therapy and cognitive behavioural therapy. It was developed by Frank Neuner, Maggie Schauer and Thomas Elbert. It follows a manualized treatment protocol published by the developers of the therapy modality. The intervention will consist of 6 to 8 weekly sessions of NET. |
| Comparator Agent |
Waitlist Control Group |
The group of participants will be placed on a waitlist and will receive the intervention after the experimental group has received it. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Experience of the event as established by the Exposure to event questionnaire.
2. Score more than or equal to predetermined cutoff score in PCL-5 (screening tool).
3. Able to understand English.
|
|
| ExclusionCriteria |
| Details |
1. Individuals currently undergoing other forms of psycho-social therapies by mental health professionals. (Individuals who have been on stable medicines for anxiety or depression for the past four weeks and are likely to not change their prescription during the course of the intervention will be included in the study)
2. Individuals with psychosis and high suicidal risk as assessed by the screening tool.
3. Individuals who are dependent or have high risk of dependence to substance as assessed by the screening tool. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Post-traumatic stress disorder (PTSD) |
At baseline, post intervention, at 1 month post intervention, at 3 months post intervention |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Depression symptoms |
At baseline, post intervention, at 1 month post intervention, at 3 months post intervention |
| Anxiety symptoms |
At baseline, post intervention, at 1 month post intervention, at 3 months post intervention |
| Psycho-social functioning |
At baseline, post intervention, at 1 month post intervention, at 3 months post intervention |
|
Target Sample Size
Modification(s)
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to assess the effectiveness of Narrative Exposure Therapy (NET) among violence affected Internally Displaced People (IDP) with post-traumatic stress disorder (PTSD) in India. The sample for the study will consist of IDP from the state of Manipur, who were displaced due to the conflict that began on May 3rd, 2023. The sample size for the study will be 35 individuals. A snowball and purposive sampling method will be used. The study is a randomized waitlist control trial with baseline, post-intervention and follow-up assessments. The study will be conducted in two phases, pilot phase and main phase. In the pilot phase, NET will be administered to 4 to 5 participants who meet the inclusion and exclusion criteria. The screening tools and assessment tools will be the same as the main phase of the study. Written feedback will be collected from participants after each session to determine if modifications in delivery, content, activities are required. Findings from this feedback will be incorporated to make any necessary adjustments to the therapy modality for the main phase, if required. For the main phase of the study, 35 screened participants who consent to participate will be included. Baseline assessments will be carried out for all participants. Following the baseline measures, participants will be randomly assigned to experimental and waitlist control group (20:15). The experimental group will be given the intervention first. Post-intervention assessments will be conducted for both experimental and control groups (control group will not have received any intervention at this point). Preliminary analysis of the control group’s scores will be performed to assess spontaneous remission and to verify whether participants continue to meet the inclusion criteria. In-depth interviews will be conducted with participants whose scores indicate spontaneous remission, to gain insight into the occurrence of spontaneous remission. The intervention will then be administered to participants in the control group who continue to meet the inclusion criteria. Post-intervention assessments for the control group will be conducted similar to those for the experimental group. 1-month follow-up assessments will be conducted for both experimental and control group participants and a 3-month follow-up assessment will be conducted among the experimental group participants, using the same tools as were used for post-intervention assessments. Data obtained will be analyzed using suitable quantitative and qualitative methods. |