| CTRI Number |
CTRI/2025/10/096692 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of Generalized anxiety on heart Rate using a smartphone based App and its changes pre and Post relaxation techniques on Heart rate |
|
Scientific Title of Study
|
Evaluation Of Efficacy Of Smartphone App Based Feedback In The Management Of Generalized Anxiety Disorder :A 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 |
Dr Sumit Mehta |
| Designation |
Professor |
| Affiliation |
shri mahant indiresh hospital |
| Address |
Department Of Psychiatry, Shri Mahant Indiresh Hospital, Prem Nagar, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8979609595 |
| Fax |
|
| Email |
sumitmehta2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Mehta |
| Designation |
Professor |
| Affiliation |
shri mahant indiresh hospital |
| Address |
Department Of Psychiatry, Shri Mahant Indiresh Hospital, Prem Nagar, Dehradun,Uttarakhand
UTTARANCHAL
248001
India |
| Phone |
8979609595 |
| Fax |
|
| Email |
sumitmehta2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARCHNA TIWARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
shri mahant indiresh hospital |
| Address |
DEPARTMENT OF PSYCHIATRY,SHRI MAHANT INDIRESH HOSPITAL,PREM NAGAR,DEHRADUN,UTTARAKHAND
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8076602576 |
| Fax |
|
| Email |
anamikatiwari004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunfox Technologies Pvt Ltd ,112 Dharampur road, Nehru colony Dharampur, Dehradun, Uttarakhand, India 248001 |
|
|
Primary Sponsor
|
| Name |
Sunfox Technologies Pvt Ltd |
| Address |
112,Dharampur Road, Nehru Colony,Dharampur,Dehradun,Uttarakhand,248001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 VIVEK PANT |
SHRI MAHANT INDIRESH HOSPITAL |
Department of Psychiatry, South Block, PREM NAGAR DEHRADUN UTTARAKHAND
Dehradun
UTTARANCHAL |
9557734969
Vivekpant_000@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
patients with a diagnosis of generalised anxiety disorder based on diagnostic criteria of diagnostic and statistical manual of mental disorders 5th edition
age 18-39 yrs
patient giving written consent to participate in protocol
patient either admitted or staying in dehradun for out patient department
patient using smartphone
patient willing to download HRV monitoring app
patient willing to learn and use relaxation technique for managing anxiety |
|
| ExclusionCriteria |
| Details |
active substance use disorder except caffeine and tobacco or any other preexisting cardiovascular disease
family history of cardiovascular disease and history of sudden cardiac death in family
history of severe mental disorder as evaluated by detailed history and mental status examination
history of unprovoked seizure neoplasm or intracranial surgery or history of severe head injury or cerebrovascular disease
patient having significant unstable medical condition like uncontrolled hypertension complicated diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there will be a significant chnages in the ECG patterns of the patient with generalized anxiety disorder and anxiety will not respond with relaxation technique with ECG monitoring |
baseline,at 2 days,at 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Despite the well established psychological impact of anxiety the extent and nature of the ECG changes in patient with GENERALIZED ANXIETY DISORDER have not been thoroughly investigated in real word clinical settings therefore the study aims to access ECG patterns in individual diagnosed with GAD using ECG patch monitoring Currently biofeedback is used in management of anxiety disorder but it is done in hospital setting the use of smartphone based app at home and the application of biofeedback mechanism in anxiety disorder involving monitoring of HRV and providing real time feedback allowing individuals to regulate them voluntarily through relaxation techniques and reduce symptoms of anxiety. So this study will be the first study to assess a portable form of HRV based biofeedback for management of anxiety. |