| CTRI Number |
CTRI/2025/07/090684 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Telemedicine] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Telemedicine versus in-person consultation for major mental illness. |
|
Scientific Title of Study
|
Efficacy of telemedicine consultation compared to in-person consultation for patients with major mental illness: An open-label randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santanu Nath |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences-Deoghar |
| Address |
Room-143, Department of Psychiatry, 1st Floor, D-Block, AIIMS, Deoghar, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
9337434349 |
| Fax |
|
| Email |
doc.santanunath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santanu Nath |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences-Deoghar |
| Address |
Room-143, Department of Psychiatry, 1st Floor, D-Block, AIIMS, Deoghar, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
9337434349 |
| Fax |
|
| Email |
doc.santanunath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santanu Nath |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences-Deoghar |
| Address |
Room-143, Department of Psychiatry, 1st Floor, D-Block, AIIMS, Deoghar, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
9337434349 |
| Fax |
|
| Email |
doc.santanunath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multidisciplinary Research Unit (MRU) of AIIMS Deoghar under DHR,
AIIMS Deoghar, Devipur, PIN: 814152, Jharkhand. |
|
|
Primary Sponsor
|
| Name |
Multidisciplinary Research Unit MRU of AIIMS Deoghar under DHR |
| Address |
Department of Health Research, New Delhi, 2nd Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Santanu Nath |
All India Institute of Medical Sciences-Deoghar |
Room-143, Department of Psychiatry, 1st Floor, D-Block, AIIMS Deoghar, Devipur
Deoghar
JHARKHAND |
9337434349
doc.santanunath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of AIIMS-Deoghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F42||Obsessive-compulsive disorder, (2) ICD-10 Condition: F20||Schizophrenia, (3) ICD-10 Condition: F31||Bipolar disorder, (4) ICD-10 Condition: F32||Major depressive disorder, singleepisode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In-person Consultation |
Participants randomized to in-person consultation arm will be provided in-person mode of consultation at 15th day (1st follow-up) and 30th day (2nd follow-up) for their mental illness. |
| Intervention |
Telemedicine |
Participants randomized to telemedicine arm will be provided telemedicine mode of consultation at 15th day (1st follow-up) and 30th day (2nd follow-up) for their mental illness. The telemedicine call will last for 10-15 minutes per patient per consultation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
• Adult patients diagnosed with major mental illness like Schizophrenia Bipolar Disorder Major Depressive Disorder and OCD were diagnosed using ICD 11.
• Able to provide written informed consent.
• Having Mobile phone with WhatsApp facility.
|
|
| ExclusionCriteria |
| Details |
• Patients with severe disease as determined by requiring inpatient care or referral to a higher centre for intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. change in CGI-S scores at all consultations to assess severity. |
Baseline, 15th, 30th, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Positive and Negative symptoms scale (PANSS) scores for schizophrenia.
2. Change in Hamilton rating scale for depression (HAM-D) for Depression.
3. Change in Yale-Brown obsessive-compulsive scale (Y-BOCS) for OCD.
4. Change in Young mania rating scale (YMRS) for Mania.
5. cost-effectiveness, patient satisfaction, and treatment adherence across the various time points. |
Baseline, 15th, 30th, 45th day |
|
|
Target Sample Size
|
Total Sample Size="496"
Sample Size from India="496"
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)
|
21/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Despite the wide use of telemedicine across India, the efficacy
of telemedicine over in-person consultations has yet to be established for mental health. This is
one of the barriers to the broader utilisation and expansion of the services from
the patient’s and clinicians’ points of view. We
could not find similar studies in the Indian context. Paper to public health translation
of telemedicine guidelines requires evidence for its usefulness across
contexts, disorders, and demographics. The current study will help generate
evidence for the feasibility of telemedicine compared to in-person
consultations for patients with severe mental illnesses like schizophrenia, bipolar disorder, OCD and depression. The hypothesis for this trial is that, the efficacy of telemedicine will be equal to an
in-person consultation for severe mental illness, and telemedicine will be cost-effective compared to in-person
consultations for the same purpose.
|