| CTRI Number |
CTRI/2026/01/100755 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [psychosocial group intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Adapting and Testing a Lifestyle Program for People with Schizophrenia and related disorders in India |
|
Scientific Title of Study
|
Lifestyle Redesign Program – Cultural Adaptation and Field Testing:
A Formative Study |
| Trial Acronym |
LSR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hepsipa Omega Juliet |
| Designation |
Clinical Coordinator |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychosocial Rehabilitation
room no 10
Schizophrenia Research Foundation
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
09176656981 |
| Fax |
|
| Email |
omega@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSubhashini Gopal |
| Designation |
Psychologist, Member Secretary of SCARF EC |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychological Services
Room No 38
Schizophrenia Research Foundation
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
9841474668 |
| Fax |
|
| Email |
subhashini@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
DrSubhashini Gopal |
| Designation |
Psychologist, Member Secretary of SCARF EC |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychological Services
Room No 38
Schizophrenia Research Foundation
Chennai
Chennai
TAMIL NADU
600101
India |
| Phone |
9841474668 |
| Fax |
|
| Email |
subhashini@scarfindia.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Schizophrenia Research Foundation |
| Address |
R/7A North Main Road,
Anna Nagar (West Extn.)
Chennai 600 101,
India |
| 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 |
| Hepsipa Omega Juliet |
Schizophrenia Research Foundation |
Schizophrenia Research Foundation
R/7A North Main Road,
Anna Nagar (West Extn.)
Chennai 600 101,
India
Chennai
TAMIL NADU |
09176656981
omega@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCARF-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifestyle redesign program |
The Lifestyle Redesign (LSR) Program is one such structured, group-based intervention originally developed in Hong Kong. It focuses on improving participation across life domains such as leisure, domestic responsibilities, social, and work. The LSR approach focuses on capacity building rather than symptom management and is grounded in a strengths-based, recovery-oriented framework that promotes autonomy and community reintegration. Notably, the program is easy to deliver, suitable across diagnostic categories, and does not require formal clinical training for facilitators (Leung et al., 2018).
LSR program consists of 10 weekly group coaching sessions, each lasting 1- 2 hours, and is facilitated by two coaches.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients: with a clinical diagnosis of schizophrenia or related disorders (ICD-10), who are clinically stable, capable of providing informed consent and only those who had participated in the LSR programme at SCARF will be considered eligible.
Caregivers: Primary caregivers (parents, siblings, spouses, or close relatives) of individuals with schizophrenia who assume day-to-day caregiving responsibilities. Caregivers unwilling to provide informed consent will be excluded.
Mental Health Professionals: Psychiatrists, psychologists, and social workers with at least two years of experience in working with individuals with schizophrenia and related disorders.
|
|
| ExclusionCriteria |
| Details |
Patients:who are acutely unwell or have unrelated cognitive impairments will be excluded.
Caregivers:unwilling to provide informed consent will be excluded.
Mental Health Professionals: Those unwilling to provide consent will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Culturally adapted LSR program for use in Indian outpatient mental health settings for persons with Schizophrenia and related disorders |
3 months post intervention qualitative feedback will be collected. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
01/09/2026 |
| 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="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
|
This study is guided by the Formative Method for Adapting Psychotherapy (FMAP), a structured collaborative framework for systematically adapting interventions to enhance their cultural relevance (Hwang, 2009). This study aims to culturally adapt and field test the Lifestyle Redesign (LSR) program for individuals with schizophrenia and related disorders in the Indian context. The LSR program is a structured, group-based psychosocial intervention originally developed in Hong Kong, focusing on enhancing participation in daily life domains such as leisure, domestic activities, social engagement, and work. The program consists of 10 weekly group coaching sessions, each lasting 1–2 hours, facilitated by two trained coaches. Given its original development in Hong Kong, a systematic formative cultural adaptation will be undertaken using focus group discussions with service users, caregivers, and mental health professionals to identify contextually relevant modifications. The adapted LSR program will then be field tested in a clinical setting among persons with schizophrenia. Qualitative feedback from participants and facilitators will be analysed to inform further refinement of the intervention and planning of a future randomized controlled trial.
|