Mental Disorders, SevereNCT03855761
Testing a Novel Community-based Occupational Therapy Model
A study testing Occupational Therapy and Case management; psychological services in people with Mental Disorders, Severe, run by Indiana University at 1 site in United States.
Trial summary
This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Occupational Therapy and Case management; psychological services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 1 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on a pre-determined treatment team at the outpatient mental health recruitment site
Who cannot join
- Under 18
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Eskenazi - Midtown Community Mental Health (James Wright Center)
Indianapolis, Indiana, 46202
About this study
Official title: Improving Equitable Care With Narrative Medicine and a Novel Community-based Occupational Therapy Care Model
This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.
Read the detailed description
In this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (OT) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within Midtown Community Mental Health (MCMH). The investigators hope to accomplish this objective via the following specific aims:1) Assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within MCMH sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) Adapt an existing care model - the Art of Healing Wellness Model (AoHW) - to meet the needs of MCMH, implement the model using an OT practitioner, and track feasibility/acceptability outcomes. 3) Re-assess MCMH programming post implementation to identify/demonstrate change resulting from the model 4) Using OT in the role of consultant, offer training to current MCMH staff to enable implementation of the adapted AoHW by MCMH (baccalaureate level) care coordinators 5) Preliminarily evaluate usability of the adapted AoHW by MCMH staff via focus groups following training and staff implementation
- Conditions
- Mental Disorders, Severe
- Being tested
- Occupational Therapy, Case management; psychological services
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Detailed narrative assessment and person-centered participation in meaningful activities
Case management; psychological servicesBehavioural
Weekly consultation with case managers to address housing and therapy needs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Experimental Occupational Therapy services Receives: Behavioral: Occupational Therapy |
| Comparison group | Active comparator | Treatment as usual Receives: Behavioral: Case management; psychological services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS)
The "Occupational Circumstances Assessment Interview and Rating Scale" is a semi-structured interview that measures a person's current participation in life in 12 areas:roles, habits, personal causation, values, interests, skills, short-term goals, long-term goals, interpretation of past experiences, physical environment, social environment, \& readiness for change. The assessment provides an overall quantitative summed score of participation ranging from 12 to 48 with a higher number indicating greater participation as well as individual scores of 1-4 for each subsection.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start18 Feb 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskenazi Health
- Responsible party
- Principal investigator, Sally Wasmuth, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855761
- Sponsor's protocol ID
- swasmuth
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Equitable Care With Narrative Medicine and a Novel Community-based Occupational Therapy Care Model
- ClinicalTrials.gov ID
- NCT03855761
- Acronym / sponsor ID
- swasmuth
- Conditions
- Mental Disorders, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eskenazi Health
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 27 Feb 2019 (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.
This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.
Detailed description
In this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (OT) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within Midtown Community Mental Health (MCMH). The investigators hope to accomplish this objective via the following specific aims:1) Assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within MCMH sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) Adapt an existing care model - the Art of Healing Wellness Model (AoHW) - to meet the needs of MCMH, implement the model using an OT practitioner, and track feasibility/acceptability outcomes. 3) Re-assess MCMH programming post implementation to identify/demonstrate change resulting from the model 4) Using OT in the role of consultant, offer training to current MCMH staff to enable implementation of the adapted AoHW by MCMH (baccalaureate level) care coordinators 5) Preliminarily evaluate usability of the adapted AoHW by MCMH staff via focus groups following training and staff implementation
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Occupational TherapyExperimental Occupational Therapy services |
| Comparison group | Active comparator | Behavioral: Case management; psychological servicesTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient on a pre-determined treatment team at the outpatient mental health recruitment site
Key exclusion criteria (2 listed)
- Under 18
- Pregnant
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 |
|---|---|---|
| Occupational TherapyDetailed narrative assessment and person-centered participation in meaningful activities | Behavioural | Intervention group |
| Case management; psychological servicesWeekly consultation with case managers to address housing and therapy needs | Behavioural | Comparison group |
Primary outcome
Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS)
Time frame: 12 weeks
The "Occupational Circumstances Assessment Interview and Rating Scale" is a semi-structured interview that measures a person's current participation in life in 12 areas:roles, habits, personal causation, values, interests, skills, short-term goals, long-term goals, interpretation of past experiences, physical environment, social environment, \& readiness for change. The assessment provides an overall quantitative summed score of participation ranging from 12 to 48 with a higher number indicating greater participation as well as individual scores of 1-4 for each subsection.
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Case management; psychological services in people with Mental Disorders, Severe, run by Indiana University at 1 site in United States.
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 2 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 11 Feb 2020. 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 United States. 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?
Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.