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CTRI Number

CTRI/2024/08/072398 [Registered on: 12/08/2024] Trial Registered Prospectively

Last Modified On:

15/12/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Behavioral
Other (Specify) [Technology enabled self-monitoring platform]

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Technology-Enabled Platform for Managing Depression in Cancer Patients in India (Pilot)

Scientific Title of Study

A randomized controlled trial to evaluate a technology-enabled platform to manage depreSsion with or without beHavioural actiVation In patieNtS with cancer in India (Pilot)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Prof Pallab K Maulik
Designation	Director of Research & Program Director - Mental Health
Affiliation	George Institute for Global Health, India
Address	Dept. of Research & Mental Health Program, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025 South DELHI 110025 India
Phone	8800493204
Fax
Email	pmaulik@georgeinstitute.org.in

Details of Contact Person
Scientific Query

Name	Prof Pallab K Maulik
Designation	Director of Research
Affiliation	George Institute for Global Health
Address	Dept. of Research & Mental Health Program, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025 South DELHI 110025 India
Phone	8800493204
Fax
Email	pmaulik@georgeinstitute.org.in

Details of Contact Person
Public Query

Name	Dr Mercian Daniel
Designation	Senior Research Fellow
Affiliation	George Institute for Global Health, India
Address	Dept. of Research & Mental Health Program, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025 South DELHI 110025 India
Phone	8800493204
Fax
Email	mdaniel@georgeinstitute.org.in

Source of Monetary or Material Support

DBT/Wellcome Trust India Alliance. Admn. office- B-2-351/N/1, Nishant House, 2nd Floor, Rd No. 2, Banjara Hills, Hyderabad, T.S. 500034.

Primary Sponsor

Name	The George Institute for Global Health, India
Address	308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Prof Rajesh Sagar	AIIMS, New Delhi	Department of Psychiatry, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, Ansari Nagar, New Delhi- 110029 South West DELHI	9810575310 rsagar29@gmail.com
Dr Samir Kumar Praharaj	Kasturba Medical College	Department of Psychiatry Kasturba Medical College Manipal, Madhav Nagar, Manipal, Karnataka- 576104 Udupi KARNATAKA	8971026304 samir.kp@manipal.edu
Dr Krishan Kumar	PGIMER, Chandigarh	Department of Psychiatry, Cobalt Block, level-3, Nehru Block Postgraduate Institute of Medical Education & Research (PGIMER) (Institute of National Importance, Government of India) Sector:12, Chandigarh - 160012 Chandigarh CHANDIGARH	8607494950 keshusony@rediffmail.com
Dr Pallab Maulik	The George Institute for Global Health, India	Dept. of Research & Mental Health Program, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025 South DELHI	8800493204 pmaulik@georgeinstitute.org.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 4
Name of Committee	Approval Status
Institute Ethics Committee, AIIMS New Delhi	Approved
Institutional Ethics Committee, PGIMER, Chandigarh	Approved
Kasturba Medical College & Kasturba Hospital IEC	Approved
The George Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, (4) ICD-10 Condition: C61||Malignant neoplasm of prostate, (5) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (6) ICD-10 Condition: C760||Malignant neoplasm of head, face and neck, (7) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (8) ICD-10 Condition: F30-F39||Mood [affective] disorders,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	Self-monitoring with integrated referral system and; Behavioral activation (Arm 3)	An internet (web-based) and mobile-technology based system to self-monitor their symptoms of depression. An Electronic Decision Support System (EDSS) will link the data from the self-monitoring tool to the clinical team who will use the data to optimize care. Patients will upload data at least once in two weeks for 9 months; 8 modules, each lasting 1 hour delivered over 8-12 weeks using a mix of in-person and online modes. The modules will include elements related to treatment pattern and objectives, realization of emotions and behaviors, identification of pleasurable and important activities, engagement of support systems, and review and self-monitoring.
Intervention	Self-monitoring with integrated referral system and (Arm 2)	An internet (web-based) and mobile-technology based system to self-monitor their symptoms of depression. An Electronic Decision Support System (EDSS) will link the data from the self-monitoring tool to the clinical team who will use the data to optimize care. Patients will upload data at least once in two weeks for 9 months.
Comparator Agent	Usual care (Arm 1)	Clinical care provided by mental health professionals as per practice; cancer treatment as per practice. The duration of the intervention will be for 9 months.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Consenting adult patients (18 years and above) suffering from breast, cervix, ovarian, lung, prostrate, colon, head, and neck cancer with comorbid depression as per screen positive cut-off score on PHQ9/GAD7 attending the relevant departments of the 3 hospitals. 2. Newly diagnosed (clinically or confirmed by radiological/pathological reports) patients (within 3 months, which includes patients with recurring/ secondary cancer) will be recruited from both inpatient and outpatients.

ExclusionCriteria

Details

1. Patients at imminent risk of suicide based on clinical assessment, or showing aggressive behavior, or lacking insight due to psychotic features;
2. Patients who score 2 or more on the Eastern Cooperative Oncology Group Performance Status (ECOG-PS);
3. Patients and caregivers who are unable to read Hindi/ English/ Punjabi/ Kannada/ Telegu (that would prevent them from responding to the self-monitoring questions).
4. Patients who are unable to speak and communicate because of the disease and treatment which hinders their participation.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome
Modification(s)

Outcome	TimePoints
A. Change in PHQ-9 depression scores in both the intervention arms compared to the control arm. B. Change in WHO-5 wellbeing scores in both the intervention arms compared to control arm.	A. Baseline (just before randomization) and at 6 months since randomization. B. Baseline (just before randomization) and at 6 months since randomization.

Secondary Outcome
Modification(s)

Outcome	TimePoints
A. Changes in PHQ-9 depression scores. B. Changes in Quality of life WHOQol-Bref scores.	A. Baseline (just before randomization) & at 9 months after randomization. B. Baseline (just before randomization) & at 9 months after randomization.

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

01/05/2025

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="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

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
Modification(s)

Aims and Hypothesis

The goal of this project is to develop and test a technology-enabled mental health care delivery platform, with or without behavioral activation (BA), for patients in India with breast, cervix, ovarian, lung, prostrate, colon, head, and neck cancer and comorbid depression, and to assess the effectiveness and cost-effectiveness of this platform in clinical practice.

Hypothesis

The primary hypotheses are that compared to usual care, both technology-enabled platform and behavioral activation will show improved depression scores on Patient Health Questionnaire-9 at 6-months.

Outcomes

There are two primary outcomes. The first primary outcome is change in scores on the PHQ9, between baseline and at 6 months since randomization in both intervention arms compared to control arm. The second co-primary outcome is change in scores on the WHO5, between baseline and at 6 months since randomization in both the intervention arms compared to control arm.