| CTRI Number |
CTRI/2025/09/094942 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study about helpful factors for enhancing Sattva in patients with common mental disorders |
|
Scientific Title of Study
|
A process- outcome study on the helpful qualities and processes in sattva enhancement therapy for 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 |
Chandana N |
| Designation |
Ph D 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 |
08903435668 |
| Fax |
|
| Email |
chandanabalakrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna 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 |
Chandana N |
| Designation |
Ph D 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 |
08903435668 |
| Fax |
|
| Email |
chandanabalakrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences,
Bengaluru-29 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences,
Bengaluru-29 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chandana N |
National Institute of Mental Health and Neurosciences |
Room No:315, Department of Clinical Psychology, Behavioural Sciences Division, Third Floor, Dr MV Govindasamy Building
Bangalore
KARNATAKA |
08903435668
chandanabalakrishnan@gmail.com |
|
|
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: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sattva enhancement therapy |
Sattva enhancement therapy is a form of psychotherapy that has
techniques adopted from the Vedic literature. The components that are used are related to concepts of
Triguna, Panchakosa, and Yogic principles. It has various modules for enhancement of Sattva, self-growth,
interpersonal harmony etc. It comprises of 12 weekly sessions (online or face to face) and has
been studied in NIMHANS in Depression and sub-clinical depression (Ayush, 2024; Lokanath, 2021).
This will be adapted for common mental disorders. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with
common mental disorders
such as depression, and
anxiety disorders as per
file diagnosis.
2. Patients with a minimum
age of 18 years.
3. Patients whose
medications are stabilized
for 1 month.
4. English speaking, with an
ability to read and answer
tools in English.
5. Formal education of 10
years. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe mental illness.
2. History of psychotic symptoms in the past
or as a comorbidity.
3. History of any neurodevelopmental
disorders or cognitive decline.
4. Any suicidal ideations in the current
episode of illness as assessed using a
suicide screening tool.
5. Patients requiring any immediate disorder
specific interventions due to its severity
such as for obsessive compulsive disorder
or emotion regulation in personality
disorders or panic disorder, substance use
disorder etc.
6. Patients undergoing any structured
psychological interventions in the last 3
months.
7. Patients with severe levels of depression
and anxiety symptoms as shown in the
assessments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimum 20 % improvement in the scores of Sattva as measured in the Triguna scale is considered as the primary outcome. |
Primary outcome variable will be measured pre and post the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/01/2026 |
| 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="3"
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
|
The study will throw light on the processes that are bringing change in an Indian psychology based psychotherapy called Sattva enhancement therapy for common mental disorders. The processes of the therapy will be studied using qualitative assessment tools while the outcome of the intervention will be studied using quantitative tools administered on patients pre and post intervention. The caregivers of the patients will also be approached for obtaining information on the patient’s improvement. Given that the process- based research is essential for informing the researchers and clinicians in what is helpful for the client in a particular psychotherapy, studying the processes in Sattva enhancement therapy can further lead to more modification and adaption based on the study findings. This will help to refine and strengthen the intervention, and creating more scope for it to undergo comparison and effectiveness studies in larger clinical samples in the future. |