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CTRI Number  CTRI/2025/12/098624 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Psycho Social Rehabilitation]  
Study Design  Single Arm Study 
Public Title of Study   Developing and Testing an Art-Based Programme for Individuals with Schizophrenia 
Scientific Title of Study   Developing and Piloting an Art-Based Intervention for Individuals with Schizophrenia: An Intervention Mapping Approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sai Rasikaa R N 
Designation  Research Fellow 
Affiliation  Schizophrenia Research Foundation (India) 
Address  Department of Psycho-Social Rehabilitation, Room no.12 Schizophrenia Research Foundation, R7A North Main Road, Anna Nagar (West Extn.), Chennai

Chennai
TAMIL NADU
600101
India 
Phone  8428172450  
Fax    
Email  sairasikaa@scarfindia.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Subhashini Gopal 
Designation  Psychologist and Member Secretary  
Affiliation  Schizophrenia Research Foundation (India) 
Address  Department of Psychology, Member Secretary of Institutional Ethics Committee Room no.38 Schizophrenia Research Foundation, R7A North Main Road, Anna Nagar (West Extn.), Chennai

Chennai
TAMIL NADU
600101
India 
Phone  9841474668  
Fax    
Email  subhashini@scarfindia.in  
 
Details of Contact Person
Public Query
 
Name  Sai Rasikaa R N 
Designation  Research Fellow 
Affiliation  Schizophrenia Research Foundation  
Address  Department of Psycho-Social Rehabilitation, Room no.12 Schizophrenia Research Foundation, R7A North Main Road, Anna Nagar (West Extn.), Chennai

Chennai
TAMIL NADU
600101
India 
Phone  8428172450  
Fax    
Email  sairasikaa@scarfindia.org  
 
Source of Monetary or Material Support  
Schizophrenia Research Foundation, R7A North Main Road, Anna Nagar (West Extn.), Chennai- 600101 Tamilnadu India  
 
Primary Sponsor  
Name  Schizophrenia Research Foundation 
Address  Schizophrenia Research Foundation R7A North Main Road, Anna Nagar (West Extn.), Chennai 600 101, India 
Type of Sponsor  Research institution and hospital 
 
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 
Sai Rasikaa R N  Schizophrenia Research Foundation  Anna Nagar West Extension Department of Psycho-Social Rehabilitation Room no. 12
Chennai
TAMIL NADU 
8428172450

sairasikaa@scarfindia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of SCARF  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Art Based Intervention  A two-phase study: (1) A structured art-based psychosocial rehabilitation programme will be co-designed using Intervention Mapping. Selected activities (mandala drawing, free drawing, Zentangle, clay modelling, group art tasks) will be tested in stakeholder workshops involving service users, caregivers, mental health professionals, and artists. Workshop findings will finalize session structure, number, duration, materials, and delivery; detailed components will be determined based on co-design outcomes. (2) pilot testing of the finalized intervention with individuals with schizophrenia. The time frame of the intervention phase is 6 weeks. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  For Mental Health Professionals:
-Willing to participant
-Have a minimum 2 years of experience working with persons with severe mental illness

For Caregivers:
- Willing to participate
- Caregivers of persons with schizophrenia

For Patients:
-Clinical diagnosis of schizophrenia (ICD-10 F20) confirmed by a psychiatrist.
-Clinically stable on pharmacological treatment for at least 3 months.
-Able to understand simple instructions and provide informed consent.
-Willing to participate in group sessions.


 
 
ExclusionCriteria 
Details  For Mental Health Professionals:
- Any condition that may limit participation in group activities.

For Caregivers:
- Any condition that may limit participation in group activities.


For Patients:
-Acute psychotic exacerbation at the time of recruitment.
-Severe cognitive impairment or intellectual disability interfering with participation.
-Comorbid substance use disorder.
-Any medical/neurological condition that may limit participation in group activities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Scale for the Assessment of Negative Symptoms (SANS)  Baseline and after 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
The Social Occupational Functioning Scale (SOFS)  Baseline & after 6 weeks 
Mindful Attention Awareness Scale (MAAS)  Baseline & after 6 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   N/A 
Date of First Enrollment (India)   02/03/2026 
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="1"
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 - NO
Brief Summary  

Individuals with schizophrenia continue to experience persistent negative symptoms, reduced motivation, social withdrawal, and limited self-efficacy despite advances in pharmacological and psychosocial treatments. Art-based approaches have shown promise in improving emotional expression, social participation, and empowerment; however, available programs in India remain fragmented, time-limited, and lack standardization. The present study aims to develop and pilot a structured, culturally relevant art-based intervention integrated with psychosocial rehabilitation for individuals with schizophrenia using the Intervention Mapping framework.

Steps 1–3 of IM were completed through an extensive literature review, identifying key needs and formulating general and performance objectives related to reducing negative symptoms, enhancing social functioning, improving mindfulness and self-awareness, and strengthening identity and self-agency. Step 4 will involve co-design workshops with stakeholders including service users, caregivers, mental health professionals, artists, and an art therapist. These workshops will test and refine selected art activities, e.g., mandala colouring, open drawing, clay modelling, Zentangle patterning, heritage arts and collaborative art tasks, to evaluate their feasibility and acceptability. Stakeholder input will shape the structure, sequence, materials, delivery methods, and contextual considerations of the intervention. Steps 5 and 6 will focus on finalizing the intervention components and developing an implementation and evaluation plan.

The completed intervention will be pilot-tested with 40 individuals with schizophrenia to assess feasibility, acceptability, and primary and secondary outcomes of the study. By combining theory-driven design with collaborative, context-specific refinement, this study aims to produce a scalable, structured art-based psychosocial rehabilitation intervention suitable for Indian mental health and rehabilitation settings. The findings will contribute to the development of structured creative interventions addressing persistent psychosocial needs in schizophrenia.

 
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