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CTRI Number  CTRI/2025/05/087213 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   "Can Yoga-Based Psychotherapy Help People Overcome Addiction? A Pilot Study" 
Scientific Title of Study   Development, Validation, and Feasibility of Yoga based Psychotherapy Program for Substance Use Disorders YPPS A Pilot Randomized Controlled Trial  
Trial Acronym  YPP-S 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreyas Chavan 
Designation  MD Yoga Scholar 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru – 560105, INDIA

Bangalore
KARNATAKA
560105
India 
Phone  7892614761  
Fax    
Email  shreyasthechavan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Nair 
Designation  Assistant Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru – 560105, INDIA

Bangalore
KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Nair 
Designation  Assistant Professor 
Affiliation  Swami Vivekananda Yoga Anusandhana Samsthana 
Address  Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru – 560105, INDIA


KARNATAKA
560105
India 
Phone  9632164777  
Fax    
Email  rajeshnair@svyasa.edu.in  
 
Source of Monetary or Material Support  
NIMHANS 
 
Primary Sponsor  
Name  NIMHANS 
Address  Hosur Road/Marigowda Road (Lakkasandra, Wilson Garden), Bengaluru 560029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemant Bhargav  National Institute of Mental Health and Neuro Sciences  Department of Integrative Medicine
Bangalore
KARNATAKA 		 8762019348

drbhargav.nimhans@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-S-VYASA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Conventional pharmacotherapy + psychosocial support + YPP-S   Participants will receive a psychotherapy program which has its theoratical basis in Yogic Philosophy. 
Comparator Agent  Group B Conventional pharmacotherapy + psychosocial support + Health Education   This group will receive health education along with usual psychosocial support and conventional treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age Adults aged 18 to 60.
2.Diagnosis Individuals who have a diagnosed substance use disorder as per the Diagnostic and Statistical Manual of Mental Disorders or DSM-5.
3.Substance Opioids
4.Willingness to Participate Participants who are willing to engage in Yogic Psychotherapy as a treatment modality for their substance use disorder.
5.Capacity to Provide Informed Consent Participants who have the cognitive and legal capacity to provide informed consent for participating in the study.
6.Mental Health Assess participants mental health to determine if they have any severe comorbid psychiatric disorders that may require specialized treatment or exclude them from the study.
7.Stability Individuals who are medically stable and not in immediate crisis or require acute medical intervention.
8.Language People who speak and understand English or Hindi.
 
 
ExclusionCriteria 
Details  1. Severe Physical Health Issues Individuals with severe physical health conditions that contraindicate participation in yoga practices
2. Severe Mental Health Issues Participants with severe comorbid psychiatric disorders that may interfere with the study objectives or require specialized treatment
3. Crisis or Acute Medical Need Individuals who are in crisis or require acute medical intervention as they may not be suitable for a research study
4. Those being treated with conventional structured psychotherapy
5. Those with a change in medications in the last 8 weeks or in whom the change would be required in the next 8 weeks 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Substance Craving – measured using the Substance Craving Scale

Days of Abstinence – measured by counting the number of abstinent days 		 outcome will be assessed/estimated at baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Anxiety – assessed using the Hamilton Anxiety Rating Scale (HAM-A)

Depression – assessed using the Hamilton Depression Rating Scale (HAM-D)

Perceived Stress – assessed using the Perceived Stress Scale (PSS)

Quality of Life – assessed using the WHO Quality of Life Scale (WHO-BREF)

Guna Composition (personality traits) – assessed using the Vedic Personality Inventory

 		 outcome will be assessed at baseline & 8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1 
Date of First Enrollment (India)   05/06/2025 
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="3"
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

  3. Who will be able to view these files?
    Response - Anyone

  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 [shreyasthechavan@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to develop and validate a structured yoga based psychotherapy protocol for substance use disorders and assess its feasibility and efficacy through a pilot randomized controlled trial. Participants aged 18 to 60 with opioid use disorders will be recruited and randomly assigned to either the intervention group receiving yoga psychotherapy with conventional treatment or the control group receiving only conventional treatment with health education. The intervention will include weekly psychotherapy and thrice weekly yoga sessions for eight weeks. Various psychological and behavioral outcomes such as substance craving, abstinence days, anxiety, depression, stress, quality of life, and personality traits will be measured before and after the intervention. Data will be analyzed using statistical software to assess feasibility, acceptability, and preliminary effectiveness of the program. 
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