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CTRI Number  CTRI/2026/03/106110 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study of High Mobile uses as a risk factor in Mental Problem of Younge adults w.s.r to Psychotherapy 
Scientific Title of Study   Study of Digital media as a risk factor in Mental Adjustment Disorders (MAD) of Young Adults w.s.r to Sattvavajaya Chikitsa (Rational Emotive Behavior Therapy) 
Trial Acronym  REBT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kirti Yadu 
Designation  Research Scholar 
Affiliation  Government Ayurved College &Hospital, Bilaspur 
Address  Department of Rognidan & Vikriti Vigyana Government Ayurved College & Hospital Nagorao Shesh Bhawan Juna Bilaspur Bilaspur

Bilaspur
CHHATTISGARH
405001
India 
Phone  7724978633  
Fax    
Email  kirti.yadu2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Nampalliwar 
Designation  Reader & HOD 
Affiliation  Government Ayurved College &Hospital, Bilaspur 
Address  Department of Rognidan & Vikriti Vigyana Government Ayurved College & Hospital Nagorao Shesh Bhawan Juna Bilaspur Bilaspur

Bilaspur
CHHATTISGARH
495001
India 
Phone  9930394087  
Fax    
Email  dr.n.amitkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Nampalliwar 
Designation  Reader & HOD 
Affiliation  Government Ayurved College &Hospital, Bilaspur 
Address  Department of Rognidan & Vikriti Vigyana Government Ayurved College & Hospital Nagorao Shesh Bhawan Juna Bilaspur Bilaspur

Bilaspur
CHHATTISGARH
495001
India 
Phone  9930394087  
Fax    
Email  dr.n.amitkumar@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences (CCRAS) 61-65, Opp. D Block, Janakpuri Institutional Area, New Delhi, Delhi 110058 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences(CCRAS) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhawan No. 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Government Ayurved College Hospital Bilaspur  Nagorao Shesh Bhawan, Juna Bilaspur, Bilaspur, chhattisgarh, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirti Yadu  Government Ayurved College & Hospital Bilaspur  Department of Rognidan & Vikriti Vigyana, Nagorao Shesh Bhawan, Juna Bilaspur, Bilaspur
Bilaspur
CHHATTISGARH 
7724978633

kirti.yadu2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Govt. Ayurved College & Hospital Bilaspur(C.G.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Digital dependent young adults 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Rational Emotive Behavior Therapy (REBT) (Procedure Reference: Ellis, A., & Joffe Ellis, D. (2019). Rational emotive behavior therapy (2nd ed.). American Psychological Association, Procedure details: Rational Emotive Behavior Therapy (REBT) as Psychotherapy will perform in 5 session of 1st, 15th, 30th, 45th & 60th day of trial)
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  a. Individual of 17- 25 years of age.
b. Individual will be selected from this institute only.
c. Individual who are active user of digital media.
d. Individual having mild, moderate sign and symptom of MAD.
e. Individual who are concern and unaware of mental health.
 
 
ExclusionCriteria 
Details  a. Individual having below 17 years and above 25 years of age.
b. Individual who are not active in digital media.
c. Individual affected from severe disorder such as Tuberculosis, Cancer, Heart disease, Epilepsy etc.
d. Individual who will not come for regular follow up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Hamilton Depression Rating Scale (HDRS)
2. Hamilton Anxiety Rating Scale (HARS)
3. Young Mania Rating Scale (YMRS)
4. Eating Disorder Diagnostic Scale (EDDS)
5. Fear Questionnaire (FQ)
 
2 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Body weight (in Kilograms)
2. Eye power (in Dioptre)
3. Blood pressure (in mm Hg )
4. Time spent on digital media (in Hrs)
5. C.B.C. - Hb%, RBC, TLC, DLC, etc.
 
2 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/03/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ccras.spark@gmail.com].

  6. For how long will this data be available start date provided 31-03-2026 and end date provided 31-03-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
tudy of Digital media as a risk factor in Mental Adjustment Disorders (MAD) of    Young Adults w.s.r to Sattvavajaya Chikitsa (Rational Emotive Behavior Therapy)
 
Introduction
Digital media such as You Tube, Podcast, Web Series, Digital arts, and Social media etc. has become a intrinsic part to our daily routine. Social media sites such as Instagram, Facebook, and Twitter have penetrated deeply into the life of young adults. Instagram has 1158 million active users’ word wide, with 62.70 % of users added 18- 34 years and 120 million active users in India as of October 2020. Deterioration in mental condition is the most common side effects derive from excessive use of digital media. According to W.H.O, the prevalence of mental health problem is increasing at a rate of 13% per year. In 2019, 1 in every 8 people, or 970 million people around the world was living with mental disorders the most common. Negative comments, self comparison, cyber bullying, number of likes, views, FOMO (Fear of missing out), may activates physiological stress response in user ultimately leads to Mental Adjustment Disorders. The symptom associated with Mental Adjustment Disorder such as mood change, sleeping problems, delusions, excessive anger, suicidal tendency etc interferes in normal life of young adults and distracts them from their life goals. 
In Ayurveda, pragyaparadh is the origin of all the diseases. Even knowing the harmful effects of excessive use of digital media young adults get attracted towards it, hence leads to Pragyapradh. Sattvavajaya Chikitsha has the pschyco- spiritual approach and, it is exclusively meant for mind. Rational Emotive Behavior Therapy as Sattvavajaya Chikitsha is a type of Cognitive Behavioral Therapy. A core concept of REBT is the ABC model. It is an action-oriented approach that’s focused on helping people deal with irrational beliefs and learn how to manage their emotions, thoughts and behavior in a healthier, more realistic way. Current scenario, there is insufficiency in mental health treatment; REBT can be a low-cost treatment option in MAD for young adults. In this study an attempt is made to assess the REBT as Sattvavajaya Chikitsha in the condition of MAD in which digital media is a risk factor.

 Objectives
1. To study role of pragyaparadh in leading to Mental Adjustment Disorder( MAD).
2. To study the digital media as a risk factor in MAD in young adult.
3. To analyze the impact of REBT as Sattvavajaya Chikitsha in MAD.
4. To improve the mental condition in digital dependent young adults.

Material and methods
IEC approval: Before trial this clinical study will be placed in IEC for approval.
The study is categorized in two steps
Step 1 Conceptual study 
In this step, the literature is reviewed, analysis of Ayurveda samhitas and modern text references are to be done. 
Step 2 Clinical study (Upashayatmaka Study)
Type of study: Longitudinal study with survey.
Study design:   It is an open labelled single arm uncontrolled clinical study.
Study population: 200 random subjects, active user in digital media.
Sample size: Sample will be drawn out of 200 subjects having mild, moderate sign and symptom of Mental Adjustment Disorder after screening by questionnaire. The current and lifetime prevalence of any psychiatric disorder in Chhattisgarh was 11.64% and 14.05%, respectively [7]. At an absolute precision of 2% and level of confidence of 95%, the estimated sample size is approximately 30 by using sample size calculator on website 
Study steps:
i. 200 young adults subject irrespective of sex and religion who are active users in digital media will be selected randomly for clinical study from this institute only. 
ii. Digital media survey questionnaire and scale (HDRS, HARS, YMRS, EDDS, FQ) questionnaire will be asked to fill by subjects.
iii. Evaluation and scoring of questionnaires will be done. Out of 200, subjects having mild to moderate sign and symptom of Mental Adjustment Disorders (MAD) will be selected for clinical study.  
iv. A written consent will be taken in prescribed proforma before clinical study. 
v. CRF will be fill according to information given by patient. 
vi. The REBT will be given in the interval of 15 days for 2 months and the result will be assessed on the basis of change in subjective and objective parameters. 
vii. At last, conclusion will be drawn on the effect of REBT in MAD in which digital media is a risk factor.
Proforma:
The patients will be interview with the help of predesigned proforma i.e. case record form (CRF) followed by clinical examination and necessary investigation. The CRF included data of name, age, sex, residence, academic session, family history, history of past illness, Srotas examination including Manovaha srotas, Asthavidha & Dasavidha parikshya, Physical & systematic examination.
       
Questionnaire Including subject detail, digital media definition, Digital media survey questionnaire, five scale (HDRS, HDAS, YMRS, EDDS, FQ) questionnaire.
Trial Duration 2 Months.
Inclusion criteria
a. Individual of 17- 25 years of age.
b. Individual will be selected from this institute only.
c. Individual who are active user of digital media.
d. Individual having mild, moderate sign and symptom of MAD.
e. Individual who are concern and unaware of mental health. 
Exclusion criteria
a. Individual having below 17 years and above 25 years of age.
b. Individual who are not active in digital media.
c. Individual affected from severe disorder such as Tuberculosis, Cancer, Heart disease, Epilepsy etc.
d. Individual who will not come for regular follow up.  
Criteria for selection of patient :  
a. Subjective criteria Subjects will be selected on the basis of score on five scales –
i. Hamilton Depression Rating Scale (HDRS): 
0–7 : the normal range (or in clinical remission),
20 : indicating at least moderate severity (usually required for entry into a clinical trial)
         ii.   Hamilton Anxiety Rating Scale (HARS):
<17 : mild severity 
18-24 : mild to moderate severity 
25-30: moderate to severe.
        iii. Young Mania Rating Scale (YMRS): 
Less or equal to 12 : resubmission
13-19 : minimal symptom
20-25 : mild mania 
26-37 : moderate mania 
38-60 : severe mania
iv. Eating Disorder Diagnostic Scale (EDDS): The grading will be asses by using software calculate by QxMD on Website 
v. Fear Questionnaire (FQ)
Four scores are obtained from the Fear Questionnaire:
Main Phobia Level of Avoidance: Item 1 (score range 0 to 8)
Total Phobia Score: Sum of items 2 to 16 (score range 0 to 120)
  Agoraphobia subscale (items 5, 6, 8, 12, & 15) (score range 0 to 40)
  Blood injury phobia subscale (items 2, 4, 10, 13, & 16) (score range 0 to 40)
Social phobia subscale (items 3, 7, 9, 11, & 14) (score range 0 to 40)
Global Phobia Rating: Item 18 (score range 0 to 8)
Associated Anxiety and Depression: Sum of items 19 to 24 (score range 0 to 40 )
As per above scale scoring, Performa will be prepared and subject will be selected for clinical study.
b. Objective criteria  Following parameters will be studied before and after clinical study 
Body weight (in Kilograms)
Eye power (in Dioptre)
Blood pressure (in mm Hg ) 
Time spent on digital media (in Hrs) 
C.B.C. - Hb%, RBC, TLC, DLC, etc.
Criteria of Assessment
The clinical study will be performing in interval of 15 days for 2 month in each patient. The objective and subjective parameters will be assess before and after of the therapy. The change will be assess on the basis of score on HDRS, HARS,YMRS, EDDS, FQ scale and change in body weight, eye power, blood pressure, time spent on digital media, C.B.C report 
Statistical Test: The observed data will be collected and collated systematically. For statistical analysis of subjective parameters Wilcoxon signed rank test will be used. After 60 days of trial the effect of therapy after 60 days of trial will assess by applying student’s paired “t” test for comparing before and after the treatment.
 Implication and future scope
This clinical study approaches to minimize the symptoms of Mental Adjustment Disorders through Rational Emotive Behavior Therapy as Sattvavajaya Chikitsha. In current scenario, there is rapid increase in number of digital media users and insufficiency in mental health treatment, REBT can be a low cost treatment option in MAD for young adults. The conclusion drawn will be beneficial for students to prevent their normal mental health condition through digital media especially social media uses and the result from clinical trial of REBT will be useful in future for treating Mental Adjustment Disorder (MAD) patients.

 
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