| CTRI Number |
CTRI/2024/04/066141 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study executive functioning, cognition, and stigma in persons with high suicide ideation and attempt |
|
Scientific Title of Study
|
To Study Executive Functioning, Metacognition, and Stigma in Persons with Suicide Ideation and Attempt |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Satyam |
| Designation |
Assistant Professor |
| Affiliation |
ABVIMS-Dr Ram Manohar Lohia Hospital |
| Address |
Room no. 12, Department of Clinical Psychology, Centre of Excellence in Mental Health
Central
DELHI
110001
India |
| Phone |
8750195861 |
| Fax |
|
| Email |
satyamcip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Triptish Bhatia |
| Designation |
Senior Research Scientist |
| Affiliation |
ABVIMS-Dr Ram Manohar Lohia Hospital |
| Address |
Room no. 30, Department of Psychiatry, Centre of Excellence in Mental Health
Central
DELHI
110001
India |
| Phone |
9910107210 |
| Fax |
|
| Email |
bhatiatriptish@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R P Beniwal |
| Designation |
Professor |
| Affiliation |
ABVIMS-Dr Ram Manohar Lohia Hospital |
| Address |
Room no. 05, Department of Psychiatry, Centre of Excellence in Mental Health
Central
DELHI
110001
India |
| Phone |
09811841351 |
| Fax |
|
| Email |
drrpbeniwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Health, USA |
|
|
Primary Sponsor
|
| Name |
AICRA Award, NIH |
| Address |
PRIIIA Hub ABVIMS & Dr RML Hospital New Delhi-110001 |
| Type of Sponsor |
Government medical college |
|
|
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 R P Beniwal |
Atal Bihari Vajpayee Institute of Medical Sciences-Dr Ram Manohar Lohia Hospital |
Room no. 30, Department of Psychiatry
Central
DELHI |
09811841351
drrpbeniwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABVIMS-Dr RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Any gender
Age between 18 to 60 years.
Able to read and write in Hindi and English
With a primary mental health diagnosis of anxiety, depression, acute stress reaction or adjustment disorder, or with no diagnosis at all
Persons with high suicidal ideation (Score 2 or more in first five items of BSSI)
Person who attempted suicide in last three months. |
|
| ExclusionCriteria |
| Details |
Any comorbid personality disorder diagnosis
Diagnosis of a major mental disorder such as Schizophrenia or Bipolar Affective Disorder.
Intellectual Disability and neurological disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observing and understanding of the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts will be hopefully able to provide better understanding of these facts related to suicidality and idea to plan for the related possible intervention. |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Helps in planning policies |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
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)
|
01/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To study executive functioning, metacognition, and stigma in persons with high suicide ideation and attempt Aims To examine the relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts. Objective To assess the executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts. To study the relationship among executive functioning, metacognitive beliefs, and stigma in persons with high suicide ideation or attempts. Novelty Observing and understanding of these facts will be hopefully able to provide better understanding of these facts related to suicidality and idea to plan for the related possible intervention. Methodology Study design: This will be a cross sectional and observational study Study setting: Department of Psychiatry and Clinical Psychology, Centre of Excellence in Mental Health, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, New Delhi. Samples size: Total number of samples for this study will be N=212. This was calculated on the basis of estimated population of 1000, and Confidence level was 0.95, with Desired precision of estimate=0.05. Sampling: Purposive sampling (Individuals with high suicide ideation or suicide attempts visiting to ABVIMS -Dr. RML Hospital for treatment) will be screen for this study. Equipment and other materials- Psychological Paper pencil test to be used, along with computers. |