| CTRI Number |
CTRI/2025/08/092477 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psycho-social intervention] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
App based intervention trial for anxiety and depression. |
|
Scientific Title of Study
|
Low Cost App based Intervention Dialog Plus For Anxiety And Depression In Outpatient Psychiatric Setting Pragmatic Multisite Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIRPIG-2024-01-01457 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7a, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7a, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmavati Ramachandran |
| Designation |
Director |
| Affiliation |
Schizophrenia Research Foundation (India) |
| Address |
R/7a, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
600101
India |
| Phone |
04426151073 |
| Fax |
|
| Email |
padmavati@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-110029, India. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikas Menon |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry - 605 006
Pondicherry
PONDICHERRY |
8098158528
drvmenon@gmail.com |
| Dr Karthick Subramanian |
Mahatma Gandhi Medical College & Research Institute (MGMCRI) |
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH
SRI BALAJI VIDYAPEETH
SBV Campus
Pillaiyarkuppam
Pondicherry- 607 402.
Pondicherry
PONDICHERRY |
9840646828
drkarthick.psy@gmail.com |
| Dr Padmavati Ramachandran |
Schizophrenia Research Foundation (India) |
R/7A, North Main Road, Anna Nagar West Extension, Chennai - 600101
Chennai
TAMIL NADU |
04426151073
padmavati@scarfindia.org |
| Dr Suvarna Jyothi Kantipudi |
Sri Ramachandra Institute of Higher Education and Research (SRIHER) |
No.1, Mount Poonamallee Road, Sri Ramachandra Nagar
Porur, Chennai - 600 116
Chennai
TAMIL NADU |
9047492143
suvarna@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics committee of SCARF |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Interventional Studies |
Approved |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, (2) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIALOG scale |
The DIALOG Scale uses a 7-point Likert scale to assess the patients satisfaction across eight life domains (mental health, physical health, employment status, housing, recreational activities, social connections, familial/partner relationships, and personal safety) and three treatment components (medication, practical assistance, and consultations with professionals).Treatment as usual is provided. |
| Intervention |
DIALOG+ |
The DIALOG scale along with a four-step solution focussed method is employed to address the patients concerns and reach a consensus on further actions. The four-
step strategy encompasses Understanding (What is the source of the patients dissatisfaction?) What went well nonetheless?; Anticipating the Future (What is the optimal outcome?) What
constitutes the minimal advancement?; Evaluating Alternatives (What actions can the patient,
doctor, or others undertake?); and ultimately, Reaching Consensus on Actions (e.g.,assignments and referrals). Treatment as usual is Provided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with depression or anxiety disorders(ICD-10 F30-F39,F40-F49)excluding bipolar disorder.
Currently experiencing anxiety and or depression.
Receiving treatment in the out-patient services of the sites.
Currently not an inpatient.
Score less than or equal to 5 on MANSA.
Capacity to provide informed consent.
Ability to communicate in Tamil or English.
|
|
| ExclusionCriteria |
| Details |
Major medical or Psychiatric comorbidities
Current alcohol or substance use disorder
(except nicotine)
Pregnant or lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Manchester Short Assessment of Quality of Life (MANSA) |
Baseline - 0 months
Midline - 3 months
Endline - 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Depression Anxiety and Stress Scale (DASS 21).
|
Baseline - 0 months
Midline - 3 months
Endline - 6 months |
| Hamiltion Anxiety Rating Scale (HAM-A) |
Baseline - 0 months
Midline - 3 months
Endline - 6 months |
Hamilton Depression Rating Scale
(HAM-D) |
Baseline - 0 months
Midline - 3 months
Endline - 6 months |
|
|
Target Sample Size
|
Total Sample Size="336"
Sample Size from India="336"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="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
|
This study protocol describes a multisite, pragmatic cluster randomized controlled trial to evaluate the effectiveness and feasibility of DIALOG Plus, a low-cost app-based intervention for people with anxiety and depression in outpatient psychiatric settings. The study is coordinated by the Schizophrenia Research Foundation India and funded by ICMR. It includes four sites in Chennai and Puducherry. The intervention involves monthly sessions using DIALOG Plus, which aims to improve quality of life and mental health through structured communication between mental health professionals and patients. The trial compares this intervention with active control. Primary outcomes include improvements in quality of life and clinical symptoms. The study involves phases of preparation, implementation of the cluster RCT, process evaluation, and data analysis.
The study will involve mental health professionals using the app-based intervention called DIALOG Plus in their routine sessions with patients (Patients with ICD 10 diagnoses of F30-F39 and F40-F49 are recruited). In the interventino group the DIALOG Plus app will be used to structure the conversation that takes place during the session. This involves going through patient satisfaction in various life domains and then discussing them further using a four-step solution-focused approach. In the control group, mental health professionals will only use the app to complete the satisfaction in life domains scale with patients.
Data will be collected at baseline, at 3 months mid point of the intervention, and at 6 months end point of the intervention. Data collection will include different tools to measure quality of life and symptom severity. Further interviews will take place with patients and mental health professionals at the end of the intervention period at 6 months to gain a more in-depth understanding of their experience of using DIALOG Plus.
A total of 24 mental health professionals and 336 patients will be recruited for the study. Each site will have 6 mental health professionals and 84 patient participants. A cluster will have one mental health professional and 14 patients. |