Mentally Ill PersonsMOHONCT07677644
MOHO's Impact on Life Skills & QoL in Mentally Ill Offenders: A Tamil Nadu Study
A study testing Model of Human Occupation (MOHO) in people with Mentally Ill Persons and Psychiatric Diagnosis, run by Sri Ramachandra Institute of Higher Education and Research at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Mentally Ill Persons, Psychiatric Diagnosis, Occupational Therapy
- What is being tested?
- Model of Human Occupation (MOHO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 5 Apr 2024to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Offenders with Physical disabilities Offenders with Activity Limitations
Trial locations and contacts
1 site in 1 country.
India1 site
Sri Ramachandra Institute of Higher Education and Research (Deemed University)
Chennai, Tamil Nadu, 636016
About this study
Official title: Effectiveness of the Model of Human Occupation (MOHO) in Enhancing Life Skills and Its Impact on Quality of Life (QoL) Among Mentally Ill Offenders in Tamil Nadu: A Quasi-Experimental Study
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.
Read more
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?
Read the detailed description
Mentally ill offenders represent a particularly vulnerable forensic population, frequently exhibiting impaired life skills and reduced quality of life (QoL) as a consequence of prolonged institutionalisation and limited occupational engagement. This quasi-experimental study examined the effectiveness of a 12-week Model of Human Occupation (MOHO)-based occupational therapy programme delivered to 12 purposively sampled mentally ill offenders in the Prisoners' Ward, Central Prison, Puzhal, Chennai, India. Participants received 24 structured occupational therapy sessions delivered twice weekly. Life skills were assessed using the Vellore Occupational Therapy Evaluation Scale (VOTES), and quality of life was measured using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). Paired-sample analysis (IBM SPSS Statistics, Version 29) revealed statistically significant improvement in life skills (p = .006), whereas no significant changes were observed across the four WHOQOL-BREF domains (p > .05). Findings indicate that MOHO-based interventions effectively enhance life skills in this forensic mental health population, supporting the integration of occupational therapy into forensic psychiatric rehabilitation programmes. The limited impact on perceived quality of life warrants further investigation through extended and individually tailored intervention designs.
- Being tested
- Model of Human Occupation (MOHO)
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model of Human Occupation (MOHO)Behavioural
Also called MOHO
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Model of Human Occupation (MOHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Quality of Life (QoL)
Quality of life (QoL) is a fundamental outcome measure in the rehabilitation of mentally ill offenders. It reflects an individual's perceived well-being across physical, psychological, social, and environmental domains. Among mentally ill offenders, QoL is severely compromised due to psychiatric illness, incarceration, stigma, and occupational deprivation.
Improving QoL is essential in forensic rehabilitation because:
Reflects holistic recovery beyond symptom reduction, encompassing functional independence and well-being Measures rehabilitation outcomes across physical, psychological, social, and environmental domains using WHOQOL-BREF Supports reintegration by improving social participation, interpersonal functioning, and community living Reduces institutionalization effects by restoring meaningful occupational roles and routines through MOHO Promotes mental health recovery by addressing individual occupational needs and priorities
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start5 Apr 2024
- Primary completion18 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mentally Ill PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 members were selected based on the inclusion and exclusion criterai and intervention was provided
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Ramachandra Institute of Higher Education and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sri Balaji Ramesh, Sri Ramachandra Institute of Higher Education and Research
- Investigators
- SriBalaji R Mr, Master in Occupational Therapy, Principal investigator, Sri Ramachandra Institute of Higher Education and research,Porur,Chennai-600116
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677644
- Sponsor's protocol ID
- CSP/23/OCT/138/882
- Other IDs
- SRIHER(DU)
- Acronym
- MOHO
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all 12 participants data will be shared
Publications
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
Moore, M. (2014). Occupational therapy and forensic psychiatry. In [Ed.], Psychiatry and mental health occupational therapy (pp. 106-114).
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
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
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
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.
PubMed 33492264Galson SK. Mental health matters. Public Health Rep. 2009 Mar-Apr;124(2):189-91. doi: 10.1177/003335490912400202. No abstract available.
PubMed 19320357Fieldhouse, J., Bryant, W., & Plastow, N. (Eds.). (2022). Creek's occupational therapy and mental health (6th ed.). Elsevier Health Sciences
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
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
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.
PubMed 24141714Swarbrick 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.
PubMed 30157004Rocamora-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.
PubMed 34716157
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Model of Human Occupation (MOHO) in Enhancing Life Skills and Its Impact on Quality of Life (QoL) Among Mentally Ill Offenders in Tamil Nadu: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07677644
- Acronym / sponsor ID
- MOHO / CSP/23/OCT/138/882
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sri Ramachandra Institute of Higher Education and ResearchUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Mentally ill offenders represent a particularly vulnerable forensic population, frequently exhibiting impaired life skills and reduced quality of life (QoL) as a consequence of prolonged institutionalisation and limited occupational engagement. This quasi-experimental study examined the effectiveness of a 12-week Model of Human Occupation (MOHO)-based occupational therapy programme delivered to 12 purposively sampled mentally ill offenders in the Prisoners' Ward, Central Prison, Puzhal, Chennai, India. Participants received 24 structured occupational therapy sessions delivered twice weekly. Life skills were assessed using the Vellore Occupational Therapy Evaluation Scale (VOTES), and quality of life was measured using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). Paired-sample analysis (IBM SPSS Statistics, Version 29) revealed statistically significant improvement in life skills (p = .006), whereas no significant changes were observed across the four WHOQOL-BREF domains (p > .05). Findings indicate that MOHO-based interventions effectively enhance life skills in this forensic mental health population, supporting the integration of occupational therapy into forensic psychiatric rehabilitation programmes. The limited impact on perceived quality of life warrants further investigation through extended and individually tailored intervention designs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 members were selected based on the inclusion and exclusion criterai and intervention was provided
| Arm | Type | Receives |
|---|---|---|
| Mentally ill Offenders in State Prison, Tamil Nadu, India | Experimental | Behavioral: Model of Human Occupation (MOHO)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Offenders with Physical disabilities Offenders with Activity Limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model of Human Occupation (MOHO)Also: MOHODescription 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 | Behavioural | Mentally ill Offenders in State Prison, Tamil Nadu, India |
Primary outcome
Life skills
Time frame: 3 months
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
1 secondary outcome
Quality of Life (QoL)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publicationOzkan, 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
- Results publicationMoore, M. (2014). Occupational therapy and forensic psychiatry. In [Ed.], Psychiatry and mental health occupational therapy (pp. 106-114).
- Results publicationLloyd, 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
- Results publicationKnott, 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
- Results publicationKirsh, 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
- Results publication: PubMed 33492264Soeker 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.
- Results publication: PubMed 19320357Galson SK. Mental health matters. Public Health Rep. 2009 Mar-Apr;124(2):189-91. doi: 10.1177/003335490912400202. No abstract available.
- Results publicationFieldhouse, J., Bryant, W., & Plastow, N. (Eds.). (2022). Creek's occupational therapy and mental health (6th ed.). Elsevier Health Sciences
- Results publicationDaffern, 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
- Results publicationCraik, 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
- Results publication: PubMed 24141714World 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.
- Results publication: PubMed 30157004Swarbrick 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.
- Individual participant dataSharing planned: Yes. all 12 participants data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SriBalaji R Mr, Master in Occupational Therapy principal investigator
Sri Ramachandra Institute of Higher Education and research,Porur,Chennai-600116
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model of Human Occupation (MOHO) in people with Mentally Ill Persons and Psychiatric Diagnosis, run by Sri Ramachandra Institute of Higher Education and Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life skills (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07677644, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.