| CTRI Number |
CTRI/2019/10/021631 [Registered on: 14/10/2019] Trial Registered Prospectively |
| Last Modified On: |
13/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Non Suicidal Self Injury in Emotionally Unstable Personality Disorder |
|
Scientific Title of Study
|
Subjective Experience of Non Suicidal Self Injury in Emotionally Unstable Personality Disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Mona Paradkar |
| Designation |
MPhil II CP |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Clinical Psychology Manipal College of Health Professions Mahe MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9011089096 |
| Fax |
|
| Email |
starmona@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Mona Paradkar |
| Designation |
MPhil II CP |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Clinical Psychology Manipal College of Health Professions Mahe MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9011089096 |
| Fax |
|
| Email |
starmona@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, Manipal |
| Address |
Department of Clinical Psychology Manipal College of Health Professions Mahe MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9449367784 |
| Fax |
|
| Email |
n.dinesh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Mona Paradkar Department of Clinical Psychology Manipal College of Health Professions MAHE Manipal |
|
|
Primary Sponsor
|
| Name |
Mona Paradkar |
| Address |
Department of Clinical Psychology Manipal College of Health Professions MAHE Manipal |
| 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 |
| Mona Paradkar |
Kasturba Medical Hospital |
Department of Clinical Psychology Manipal College of Health Professions Manipal
Udupi
KARNATAKA |
9011089096
starmona@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F603||Borderline personality disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either gender, in age group of 18-25 years fluent in English and Hindi. Clinical sample diagnosed with Emotionally Unstable Personality Disorder and individuals who have engaged in the act of NSSI more than once in the last 6 months. |
|
| ExclusionCriteria |
| Details |
Past history of any suicidal attempt. Presence of other psychiatric conditions like psychosis or schizophrenia or mania or delusional disorder or mental retardation or organic condition. Presence of other personality disorders including antisocial, histrionic and narcissistic personality disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the subjective experience of non suicidal self injury in emotionally unstable personality disorder |
To explore the subjective experience of non suicidal self injury in emotionally unstable personality disorder |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
21/10/2019 |
| 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="20"
Months="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to explore the subjective experience of non suicidal self injury (NSSI) in individuals with emotionally unstable personality disorder (EUPD). The act of deliberately injuring onself is a puzzling behaviour to understand, but one which has received increased attention from researchers in recent years. There is research evidence that EUPD patients use NSSI to achieve quick relief from negative emotions and from strong aversive inner tension. While quantitative research studies have investigated the phenomenon of NSSI in clinical as well as non clinical sample, there is a dearth of studies which have looked into, in a holistic manner, the unique experiential account of individuals with EUPD who engage in NSSI. The experience in totality, in a clinical population, can give a realistic account of the inner world of the persons with EUPD and help to gain insight about the unique patterns of self-injury among these individuals and consequently allow for targeted interventions, thus increasing the applicability of the findings to the clinical setting. |