NCT07677644

Brief Summary

What is the goal of this study? The goal of this study is to learn if a 12-week occupational therapy programme based on the Model of Human Occupation (MOHO) can improve life skills and quality of life in mentally ill offenders in Chennai, India. Who will take part? 12 mentally ill offenders from the Prisoners' Ward, Central Prison, Puzhal, Chennai will take part in this study. What will participants do? Participants will: Attend 24 structured occupational therapy sessions, twice a week for 12 weeks Be assessed for life skills using the Vellore Occupational Therapy Evaluation Scale (VOTES) Be assessed for quality of life using the WHOQOL-BREF questionnaire What are the main questions this study aims to answer? Does a MOHO-based occupational therapy programme improve life skills among mentally ill offenders? Does a MOHO-based occupational therapy programme improve quality of life among mentally ill offenders?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 17, 2026

Last Update Submit

June 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Life skills

    Mentally ill offenders frequently experience significant deterioration of essential life skills due to prolonged institutionalization, psychiatric symptoms, and limited occupational engagement. Life skills rehabilitation is therefore critical in this forensic population for the following reasons: Addresses occupational dysfunction by targeting volition, habituation, and performance capacity through MOHO-based intervention Reduces recidivism by equipping offenders with practical competencies necessary for community reintegration Enhances quality of life across physical, psychological, social, and environmental domains Supports forensic psychiatric rehabilitation\*\* through structured, evidence-based occupational therapy Promotes social inclusion by fostering self-efficacy, role competence, and community participation Empowers a vulnerable population by addressing occupational needs and supporting recovery-oriented outcomes

    3 months

Secondary Outcomes (1)

  • Quality of Life (QoL)

    3 months

Study Arms (1)

Mentally ill Offenders in State Prison, Tamil Nadu, India

EXPERIMENTAL

Mentally ill offenders are individuals diagnosed with a psychiatric disorder who are concurrently involved in the criminal justice system. This arm comprises 12 purposively sampled mentally ill offenders residing in the Prisoners' Ward, Central Prison, Puzhal, Chennai, Tamil Nadu, India. Participants will receive a structured 12-week MOHO-based occupational therapy intervention consisting of 24 sessions delivered twice weekly by a trained occupational therapist. Sessions will incorporate MOHO constructs - volition, habituation, and performance capacity - to address occupational dysfunction. Activities will focus on self-care, daily living, communication, interpersonal skills, and community reintegration. Life skills will be assessed using the Vellore Occupational Therapy Evaluation Scale (VOTES) and quality of life will be measured using the WHOQOL-BREF at baseline and post-intervention.

Behavioral: Model of Human Occupation (MOHO)

Interventions

Description of MOHO (Model of Human Occupation): The Model of Human Occupation (MOHO) is a client-centred occupational therapy theoretical framework developed by Gary Kielhofner in 1980. MOHO explains how humans are motivated to engage in occupation, how occupational patterns are organised, and how occupation is performed within the environment. It is built upon three core subsystems: Volition- refers to the motivation for occupation, encompassing personal causation, values, and interests \*Habituation- refers to the organisation of occupation into patterns and routines through roles and habits Performance Capacity- refers to the physical and mental abilities that enable occupational performance MOHO emphasises that meaningful occupational engagement is essential for health, well-being, and quality of life. It considers the dynamic interaction between the person, their occupation, and the environment. MOHO-based interventions are widely used in psychiatric and

Also known as: MOHO
Mentally ill Offenders in State Prison, Tamil Nadu, India

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Offenders committed crimes under the section IPC \& CrPc of Indian Constitution April,1 1974 Offenders from age 18 to 64 (14.1 % to 13.9 % Male prevalence) Male offenders with or without differential diagnosis of psychotic symptoms HCR-20 V3 Risk assessment tool score ranging from low to moderate level Short Orientation Memory Concentration Test (OMCT) scores ranging from 0-19

You may not qualify if:

  • Offenders with Physical disabilities Offenders with Activity Limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sri Ramachandra Institute of Higher Education and Research (Deemed University)

Chennai, Tamil Nadu, 636016, India

Location

Related Publications (13)

  • Ozkan, E., Belhan, S., Yaran, M., & Zarif, M. (2018). Occupational therapy in forensic settings. In [Eds.], Occupational therapy - therapeutic and creative use of activity. IntechOpen. https://doi.org/10.5772/intechopen.80726

    RESULT
  • Moore, M. (2014). Occupational therapy and forensic psychiatry. In [Ed.], Psychiatry and mental health occupational therapy (pp. 106-114).

    RESULT
  • Lloyd, C., & Williams, P. L. (2010). Occupational therapy in the modern adult acute mental health setting: A review of current practice. International Journal of Therapy and Rehabilitation, 17(9), 483-493. https://doi.org/10.12968/ijtr.2010.17.9.78414

    RESULT
  • Knott, G., & Bannigan, K. (2013). A critical review of the approved mental health professional role and occupational therapy. British Journal of Occupational Therapy, 76(3), 118-126. https://doi.org/10.4276/030802213X13627524435119

    RESULT
  • Kirsh, B., Martin, L., Hultqvist, J., & Eklund, M. (2019). Occupational therapy interventions in mental health: A literature review in search of evidence. Occupational Therapy in Mental Health, 35(2), 109-156. https://doi.org/10.1080/0164212X.2018.1508603

    RESULT
  • Soeker MS, Hare S, Mall S, van der Berg J. The value of occupational therapy intervention for the worker roles of forensic mental healthcare users in Cape Town, South Africa. Work. 2021;68(2):399-414. doi: 10.3233/WOR-203381.

  • Galson SK. Mental health matters. Public Health Rep. 2009 Mar-Apr;124(2):189-91. doi: 10.1177/003335490912400202. No abstract available.

  • Fieldhouse, J., Bryant, W., & Plastow, N. (Eds.). (2022). Creek's occupational therapy and mental health (6th ed.). Elsevier Health Sciences

    RESULT
  • Daffern, M., & Chu, C. M. (2024). Approaches to offender rehabilitation in Asian jurisdictions. In J. Creek, L. Lougher, & A. Plastow (Eds.), Creek's occupational therapy and mental health

    RESULT
  • Craik, C. (1998). An overview of the literature on occupational therapy in mental health. British Journal of Occupational Therapy, 61(5), 186-192. https://doi.org/10.1177/030802269806100502

    RESULT
  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  • Swarbrick M, Noyes S. Effectiveness of Occupational Therapy Services in Mental Health Practice. Am J Occup Ther. 2018 Sep/Oct;72(5):7205170010p1-7205170010p4. doi: 10.5014/ajot.2018.725001.

  • Rocamora-Montenegro M, Compan-Gabucio LM, Garcia de la Hera M. Occupational therapy interventions for adults with severe mental illness: a scoping review. BMJ Open. 2021 Oct 29;11(10):e047467. doi: 10.1136/bmjopen-2020-047467.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • SriBalaji R Mr, Master in Occupational Therapy

    Sri Ramachandra Institute of Higher Education and research,Porur,Chennai-600116

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 12 members were selected based on the inclusion and exclusion criterai and intervention was provided
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 1, 2026

Study Start

April 5, 2024

Primary Completion

July 18, 2024

Study Completion

July 23, 2024

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

all 12 participants data will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
April 5,2024 to July 18,2024
Access Criteria
The principal investigator will be able to access the IPD, they will be accessing the data's of the patients by means of recoded data
More information

Locations