| CTRI Number |
CTRI/2025/08/093351 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the role of psychosocial and clinical factors on suicidal thoughts and behaviours in Older adults with common mental health conditions |
|
Scientific Title of Study
|
Psychosocial and clinical correlates of suicidality in older adults with common mental disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepthi Bisoi |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of mental health and Neurosciences |
| Address |
Department of Clinical Psychology, Dr MV Govindswamy Building, NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9845518927 |
| Fax |
|
| Email |
deepthi.jpn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
National Institute of mental health and Neurosciences |
| Address |
Department of Clinical Psychology, Dr MV Govindswamy Building, NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9448083521 |
| Fax |
|
| Email |
paulomi@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Clinical Psychology, Dr MV Govindswamy Building, NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9448083521 |
| Fax |
|
| Email |
paulomi@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institute of mental health and Neurosciences, Hosur road, Bengluru,Karnataka,India
Pin code:560029 |
|
|
Primary Sponsor
|
| Name |
Deepthi Bisoi |
| Address |
Dept. of Clinical Psychology, Dr MV Govindswamy Building, NIMHANS,Bengaluru-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 |
| Dr Paulomi M Sudhir |
National Institute of Mental Health and Neurosciences |
3rd floor,Department of Clinical Psychology, Dr MV Govindswamy Building , NIMHANS, hosur road, Bengaluru-560029
Bangalore
KARNATAKA |
9448083521
paulomi@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Behavioural Sciences Division,NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent, (3) ICD-10 Condition: F34||Persistent mood [affective] disorders, (4) ICD-10 Condition: F39||Unspecified mood [affective] disorder, (5) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. A primary Diagnosis of : Depressive disorders (F32.0, F32.1, F32.2, F32.8, F32.9, F33.0,F33.1,F22.2,F33.4,F33.8,F33.9, F34,F38, ,F39) and Neurotic, stress-related and somatoform disorders(F40-F48)
2. Capacity to consent
3. Ability to speak and understand English/Kannada/Hindi/Telugu.
|
|
| ExclusionCriteria |
| Details |
1. A primary diagnosis as per ICD 10 codes :Mental and behavioural disorders due to psychoactive substance use(F10-F19), Schizophrenia, schizotypal and delusional disorders(F20-29), Bipolar affective disorder (F31), Severe depressive episode with psychotic symptoms (F32.3),Recurrent depressive disorder, current episode severe with psychotic symptoms(F33.3)
2. Diagnosis of Dementia, history suggestive of any neurological or medical illness that can interfere with the ability to participate in the study
3. Intellectual Disability
4. Sensory impairments like hearing or vision loss.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Suicidality including suicidal ideations, death wishes and suicide attempts. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| perspectives of older adults with Common mental disorders who have previous experience of suicidality |
One time |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
29/09/2025 |
| 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="3"
Months="0"
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
|
This study aims to examine the psychosocial and clinical correlates of suicidality in older adults with common mental disorders (CMDs). It incorporates a cross-sectional mixed-method design using purposive sampling. The sample size is 150 older adults with CMDs, and a subgroup of 10 will be taken up for in-depth interviews. The Psychosocial factors include sociodemographic factors, role transitions, life events, hopelessness, perceived burdensomeness, thwarted belongingness, meaning in life, psychological flexibility, coping, emotion regulation and social support. The clinical factors include Illness duration, severity of illness, comorbidity, physical mobility status, family history of completed suicide and mood severity. The primary outcome measure is suicidality among older adults with CMDs.The relationship of psychosocial factors with suicidality in older adults with CMDs will be explored. Further, the clinical factors associated with suicidality among older adults will also be examined.
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