| 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
|
|
|
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
|
|
|
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. |