| CTRI Number |
CTRI/2019/12/022369 [Registered on: 13/12/2019] Trial Registered Prospectively |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychotherapy-Narrative Exposure Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see if the Narrative Therapy approach is feasible for women who have experienced violence and its consequences from their spouses and are currently living in shelter homes. |
|
Scientific Title of Study
|
Feasibility of Narrative Exposure Therapy for IPV Related Trauma among Women in a Short Stay Shelter Home |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa K S |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8971216158 |
| Fax |
|
| Email |
srinath.shilpa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L N Suman |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995189 |
| Fax |
|
| Email |
elenes@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
L N Suman |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bangalore
Koppal
KARNATAKA
560029
India |
| Phone |
080-26995189 |
| Fax |
|
| Email |
elenes@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS) |
|
|
Primary Sponsor
|
| Name |
Shilpa K S |
| Address |
National Institute of Mental Health and Neurosciences (NIMHANS) Hosur road Bangalore 560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shilpa K S |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology, MV Govindswamy building, Hosur Road, Bangalore-560029
Bangalore
KARNATAKA |
8971216158
srinath.shilpa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences (NIMHANS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women who have experienced Intimate Partner Violence (IPV) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Narrative Exposure Therapy (NET) |
Narrative exposure therapy (NET) is an evidenceâ€based, shortterm treatment developed by Schauer, Neuner and Elbert in 2002 for the purpose of treatment of PTSD resulting from exposure to multiple traumatic events. With a relatively small number of 90 to 120 minute sessions, usually about 10 once or twice a week, the individual constructs a detailed narrative of his or her biography with the help of a therapist. The main goal of NET is to create a consistent declarative (autobiographical) representation of sequelae of events experienced by the individual. The act of creating this coherent narrative enables the individual to be exposed to the sensory image of single events. This process allows for habituation and reduces fear response over time. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women who have experienced IPV from their married partner
Women above 18 years of age
Women with working knowledge of Kannada or English
Women who score above the cut off on Kessler’s scale for psychological distress
Women who give written informed consent
Women who have stayed at the shelter home for at least one week.
|
|
| ExclusionCriteria |
| Details |
Women with psychotic disorders as screened on Modified MINI
Women with clinical evidence of mental retardation
Women with serious physical illnesses such as HIV/AIDS
Women who are found to be severely distressed on the Kessler’s scale for psychological distress
Women should not have undergone structured psychotherapy in the last 1 year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing post-traumatic stress symptoms (PTSD Checklist 5 scores), depressive symptoms (Patient Health Questionnaire 9 scores) and trauma related anger (Trauma Related Anger Scale score).
Improving trauma related cognitive processing( Cognitive Processing of Trauma Scale scores) , trauma coping self-efficacy( Trauma Coping Self Efficacy Scale scores) and psychological well being ( Psychological Well-Being Scale scores) |
Pre-intervention assessment, post-intervention assessment immediately after the completion of 8-10 sessions of NET and assessments at 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the factors and processes perceived to be therapeutic by the clients. |
post-intervention immediately after the completion of 8-10 sessions of NET |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/12/2019 |
| Date of Study Completion (India) |
03/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Shilpa K S, Suman L N. Coping, resilience, and hopefulness among women survivors of Intimate Partner Violence (IPV). Arch Ment Health 2020;21:65-70
2.Shilpa K S, Suman L N. Histories of intimate partner violence among women in short-stay shelter homes: Implications for psychosocial interventions. Telangana J Psychiatry 2022;8:39-45 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim: The aim of the present study is to examine the
effectiveness of Narrative Exposure Therapy (NET) in improving trauma related
symptoms, cognitions and emotions among women survivors of IPV in a short stay
shelter home. Primary objectives
1. To examine the nature and severity of IPV among
women survivors of IPV
2. To examine feasibility of NET for IPV related trauma
3. To assess the effectiveness of NET in reducing
post-traumatic stress symptoms, depressive symptoms and trauma related anger
4. To assess the effectiveness of NET in improving
trauma related cognitive processing, trauma coping self-efficacy and psychological
well-being
5. To examine the relationship between severity of IPV
and outcome variables
6. To examine the relationship between adverse
childhood experiences and outcome variables
7. To examine the interrelationships among the outcome
variables
Secondary objective
To examine the factors and processes perceived to be
therapeutic by the clients. Research design Single group design with pre and post therapy
assessments conducted at 3 different points in time: Pre-intervention
assessment, post-intervention assessment immediately after the completion of
8-10 sessions of NET and assessments at 1 month follow up Sample 30 women survivors of IPV currently residing in
‘Mahila Dakshata Samiti (MDS),’ a shelter home in Bangalore who give written informed
consent. Other shelter homes might be considered if the sample is difficult to
obtain from a single shelter. Sampling
Convenience sampling will be used to select the
sample based on the inclusion and exclusion criteria. Procedure: 1. Thirty clients will be recruited for NET.
2. The main phase will be carried out in 4 phases:
pre-therapy assessments, narrative exposure therapy and post-therapy
assessments immediately after completion of the therapy sessions and
assessments at 1 month follow up.
3. Those who undergo less than 4 will be considered as
drop outs, and those who undergo minimum of 4 therapy sessions will be
considered as completers.
4. Exit interviews will be conducted to examine factors
and processes perceived to be therapeutic by the clients undergoing NET. |