| CTRI Number |
CTRI/2026/01/100878 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Sattva-based well-being programme on relationships and daily functioning in adults with depression and anxiety |
|
Scientific Title of Study
|
Efficacy of a Sattva-Enhancement Intervention on Interpersonal and Executive Functioning: A Randomized Controlled Trial among Adults with Common Mental Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tara M Hari |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
7306502360 |
| Fax |
|
| Email |
tara.phcps202418@nimhans.net |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJyotsna Agrawal |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995862 |
| Fax |
|
| Email |
jyotsna.e02049@nimhans.net |
|
Details of Contact Person
Public Query
|
| Name |
DrJyotsna Agrawal |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995862 |
| Fax |
|
| Email |
jyotsna.e02049@nimhans.net |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Bengaluru 560029, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
University Grants Commission (UGC) |
| Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002. · 011-23604127, 011-23604200 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Tara M Hari |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, 560029
Bangalore
KARNATAKA |
07306502360
tara.phcps202418@nimhans.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee (Behavioural Science Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (2) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (3) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (4) ICD-10 Condition: F33||Major depressive disorder, recurrent, (5) ICD-10 Condition: F34||Persistent mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sattva Enhancement Intervention |
This structured 12 session program with total duration of 8 weeks consisting of bi weekly sessions (60 minutes each) for first month and weekly sessions (60 minutes each). Sattva Enhancement Therapy is a holistic intervention based on Yoga Vasishta,
Bhagavadgita, and Patanjali Yogasutra aimed at improving interpersonal harmony and executive functioning. The therapy incorporates self-care practices rooted in Niyama and ethical living through Yama. It also emphasizes cultivating the Chaturbhavana or the four relational attitudes of maitri (friendliness), mudita (sympathetic joy), karuna (compassion), and upeksha (equanimity) to foster interpersonal harmony, supporting emotional balance, improved cognitive control, and healthier social interactions (Ganer, 2025; Ayush, 2024; Lokanathan, 2021, Agrawal, 2021; Sahota, 2020). |
| Comparator Agent |
Treatment as Usual (TAU) |
The comparator group will receive Treatment as Usual (TAU) for a total duration of 8 weeks, which includes psychoeducation and standard clinical care such as information on illness management, healthy routines, and stress reduction.
To understand the effects of the intervention, all participants, regardless of group, will be assessed at four different time points. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients (with Depression and/or Anxiety):
1. Diagnosed with CMDs based on DSM-5/ICD 11 criteria. Common mental disorders (CMDs) for study includes, depression, and anxiety spectrum disorders, with Axis II status documented and treated as a covariate
2. Aged between 18 and 55 years.
3. Minimum ten years of formal education and ability to provide informed consent and participate in the intervention and assessments.
4. Fluency in English Language, with ability to comprehend English text in assessment tools and respond to it
5. Stabilized on medication for four weeks prior to the entry into the study
6. Willingness to maintain stable medication regimen for the duration of the 8 week intervention. Any change will result in exclusion from final analysis.
|
|
| ExclusionCriteria |
| Details |
1. A primary diagnosis of Psychosis, Schizoaffective disorder, Bipolar affective disorder (current episode mania), Current episode of severe depression with or without psychotic symptoms
2. Trauma-related disorders like PTSD, and OCD
3. Adults with active suicidal ideation or attempts
4. History and clinical impression suggestive of intellectual disability
5. History suggestive of any debilitating medical/ neurological/ neurosurgical/ general medical illness etc requiring priority management or which could interfere with assessment or therapy
6. Planned changes to medication regimen during the intervention period.
7. Adults who have received a structured psychological intervention of more than 8 sessions in the past six months for depression or anxiety
8. Adults who are currently undergoing any structured psychotherapeutic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interpersonal Functioning (Pre and Post using Inventory of Interpersonal Problems-32 with 20% improvement (Roy & Mukhopadhyay, 2018))and using Interdependent Happiness Scale at all 4 time points) |
Baseline, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Executive Functioning |
Baseline & 8 weeks |
| Well Being |
Baseline & 8 weeks |
| Psychological Distress |
Baseline & 8 weeks |
| Indian Psychology Constructs (Sattva) |
Baseline & 8 weeks |
|
|
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)
|
01/03/2026 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The primary purpose of this study is to conduct a Sattva-Enhancement Intervention on patients with Depression (Mild-Mod) and Anxiety diagnoses to evaluate its impact on Interpersonal Functioning. The study also seeks to examine the effect of this intervention on Executive Functioning, Psychological Distress and Well- Being. This study is a randomized controlled trial (RCT) where one group will receive the Sattva-Enhancement Intervention, which consists of 12 individual sessions spread over 8 weeks. The other group will receive Treatment as Usual (TAU), which includes psychoeducation and standard clinical care such as information on illness management, healthy routines, and stress reduction. Caregivers will also be approached to provide information regarding patient’s condition.
The Sattva-Enhancement Intervention is a structured psychological program delivered in a religiously neutral, culturally sensitive manner. It focuses on self-discovery and inner experiences, and strengthens positive inner qualities that support well-being. Sessions integrate reflective discussion, guided meditation, and simple home-based practices. The intervention is informed by classical Indian psychological and yogic frameworks, including concepts drawn from the Yoga Vasishta, Bhagavad Gita, and Patanjali Yoga Sutra. The program includes self-care and inner discipline practices aligned with Niyama, and promotes ethical and adaptive behavioural orientations aligned with Yama. It also emphasizes cultivating the four relational attitudes known as Chaturbhavana, namely maitri (friendliness), karuna (compassion), mudita (sympathetic joy), and upeksha (equanimity), to foster healthier social interactions, emotional balance, improved cognitive control, and flexible responding in interpersonal situations.
This study advances applied Indian psychology, addressing gaps in cultural congruence and holistic treatment. The intervention simultaneously targets interpersonal and executive functioning, symptom reduction, and overall psychological recovery, contributing to enhanced quality of life. The study will validate the therapeutic relevance of certain interconnected indigenous constructs (Sattva, Yama-Niyama, Chaturbhavana), utilizing both standardized Western psychometric instruments and indigenous tools, enhancing their conceptual coherence and applicability. Outcomes from this study will significantly advance culturally congruent interventions within India’s mental health system, providing a validated foundation for scalable, accessible treatments suitable for diverse populations experiencing Depression and Anxiety. |