Occupational TherapyNCT04465422

Development and Validation of the Client Centered Occupational Therapy Service Model

A study testing Occupational therapy based on the MOHO theory and Occupational therapy in people with Occupational Therapy and Psychiatric Rehabilitation, run by Taipei City Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Occupational Therapy, Psychiatric Rehabilitation
What is being tested?: Occupational therapy based on the MOHO theory and Occupational therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteTaiwan
Study dates: 19 Jun 2020to 16 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.
Over 20 years old.
Agree to participate in the study

Who cannot join

1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei City Hospital
Taipei, 110209

Other trials in Taiwan

About this study

Read the detailed description

Occupational Therapy (OT) is one of the mental health services. The service phase includes acute/chronic hospitalization, daycare centers (adolescents, adults, and the elderly), community mental rehabilitation institutions, psychiatric nursing home, and outpatient assessment/treatments. OT provides holistic and continuous mental rehabilitation services at each stage of mental health care. During the acute hospitalization and based on the Model of Human Occupation (MOHO) model, the occupational therapist provides daily activities to assist acute patients with mental illness to develop occupation adaptation to enable and prepare for discharge.

However, the lack of a client-centered OT service model limits the interpretation of the treatment effect and the process of change. This will seriously affect the integrity and continuity of OT services and will limit the development of OT professions. Thus, the purpose of the study is to develop and validate Client-centered Occupational Therapy Service at Taipei City Psychiatric Center (OT@tcpc) service model to assist clinicians to provide and integrate comprehensive OT services.

This project consists of 2 stages. First, based on the MOHO model we use 5 stages with 6 weeks program to develop the OT@tcpc service model. Second, validate the to indicate the occupation identity and competence to validate the OT@tcpc service model. We will recruit 70 inpatients with schizophrenia and divided into intervention group, based on MOHO theory, and control group.

Conditions: Occupational Therapy, Psychiatric Rehabilitation
Being tested: Occupational therapy based on the MOHO theory, Occupational therapy
Keywords: client-centered, Model of Human Occupation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Occupational therapy based on the MOHO theoryBehavioural
We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.
OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
Occupational therapyBehavioural
The original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.

Study groups in NCT04465422
Study group	Role	What they receive
Intervention Group	Experimental	We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. The research at this stage is based on the theoretical framework of the MOHO model and the clinical practice of OTPF-3. Clinical experts are requested to assist in providing relevant suggestions as a reference for modifying intervention activities. Design OT@tcpc service model for occupational therapy intervention activities. The event design is based on the 4 systems of determinationl, habits, performance and environment, and 2 events are designed for each to be carried out in a group. Each activity includes 4 parts: warm-up, activity, feedback and homework. Each activity group will be explained separately so that the occupational therapist of the group can complete it under the guidance. Receives: Behavioral: Occupational therapy based on the MOHO theory
Control Group	Active comparator	We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. This study was approved by the Institutional Review Board of Taipei City Hospital. After informed consent, the patients signed the consent form for this study and became the participant of this study. Each activity group will be explained separately so that the participants of each group can complete it under the guidance. The group description includes: activity title, activity time (location), MOHO theory system, group purpose, activity content, equipment or materials, precautions, etc. Receives: Behavioral: Occupational therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores
The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36).
The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).
Measured: 2 weeks

Secondary outcomes (1)

Occupational Therapy Evaluation Scales Measure
Except for Mini-Menlal State Examination(MMSE), all other tools were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model
The secondary outcome included the following instruments:
1. Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability)
2. Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance)
3. Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance)
4. Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance)
5. Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance)
6. Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 202016 Jul 2020

First posted10 Jul 2020
Study start19 Jun 2020
Primary completion16 Jul 2020
Study completion16 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Occupational TherapyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465422
Sponsor's protocol ID: TCHIRB-10904021
Status last verified: Jun 2020
First submitted: 7 Jul 2020
Last updated: 24 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lee J. Achieving best practice: a review of evidence linked to occupation-focused practice models. Occup Ther Health Care. 2010 Jul;24(3):206-22. doi: 10.3109/07380577.2010.483270.
PubMed 23898928
Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. doi: 10.5014/ajot.62.1.106.
PubMed 18254437
Lee SW, Kielhofner G, Morley M, Heasman D, Garnham M, Willis S, Parkinson S, Forsyth K, Melton J, Taylor RR. Impact of using the Model of Human Occupation: a survey of occupational therapy mental health practitioners' perceptions. Scand J Occup Ther. 2012 Sep;19(5):450-6. doi: 10.3109/11038128.2011.645553. Epub 2012 Jan 3.
PubMed 22214401
Melton J, Forsyth K, Metherall A, Robinson J, Hill J, Quick L. Program Redesign Based on the Model of Human Occupation: Inpatient Services for People Experiencing Acute Mental Illness in the UK. Occup Ther Health Care. 2008;22(2-3):37-50. doi: 10.1080/07380570801989382.
PubMed 23941371

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
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Supplemental Mobility
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All Occupational Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Validation of the Client Centered Occupational Therapy Service Model
ClinicalTrials.gov ID: NCT04465422
Acronym / sponsor ID: TCHIRB-10904021
Conditions: Occupational Therapy, Psychiatric Rehabilitation
Keywords: client-centered, Model of Human Occupation
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Taipei City HospitalOther government
Study start: 19 Jun 2020 (actual)
Primary completion: 16 Jul 2020 (actual)
Study completion: 16 Jul 2020 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 2 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: Occupational therapy based on the MOHO theoryWe will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. The research at this stage is based on the theoretical framework of the MOHO model and the clinical practice of OTPF-3. Clinical experts are requested to assist in providing relevant suggestions as a reference for modifying intervention activities. Design OT@tcpc service model for occupational therapy intervention activities. The event design is based on the 4 systems of determinationl, habits, performance and environment, and 2 events are designed for each to be carried out in a group. Each activity includes 4 parts: warm-up, activity, feedback and homework. Each activity group will be explained separately so that the occupational therapist of the group can complete it under the guidance.
Control Group	Active comparator	Behavioral: Occupational therapyWe will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory, while the control group adopted the original Occupational therapy model. This study was approved by the Institutional Review Board of Taipei City Hospital. After informed consent, the patients signed the consent form for this study and became the participant of this study. Each activity group will be explained separately so that the participants of each group can complete it under the guidance. The group description includes: activity title, activity time (location), MOHO theory system, group purpose, activity content, equipment or materials, precautions, etc.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria.
Over 20 years old.
Agree to participate in the study

Key exclusion criteria (1 listed)

1. Diagnosis of intellectual developmental disorders 2. History of severe brain injury 3. Cannot complete the study due to poor cognitive, vision or hand function

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 therapy based on the MOHO theoryWe selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.	Behavioural	Intervention Group
Occupational therapyThe original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.	Behavioural	Control Group

Primary outcome

Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores
Time frame: 2 weeks
The Occupational Performance History Interview-Second Version(OPHI-II) was tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model. OPHI-II is a semi-structured interview that gathers life history information. The OPHI-II contains 3 sub-domains: OPHI-II Occupational Identity(range 11~44)、OPHI-II Occupational Competence(range 9~36)、OPHI-II Occupational Behavior Settings(range 9~36). The three sub-domains are divided into 4 levels, in which 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 points indicate poor functions. The total score of OPHI-II is equal to the sum of the three sub-domains (scores 29 to 116; higher scores indicate higher performance).

1 secondary outcome

Occupational Therapy Evaluation Scales Measure
Time frame: 2 weeks

Results and safety

Results posted to the registry on 2 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	17	17
Control Group	16	14

Primary outcome: Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores

Time frame: 2 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Group n = 17	Control Group n = 16
OPHI-II Total score (pretest)	66.2 (8.0)	69.4 (6.8)
OPHI-II Occupational Identity (pretest)	24.9 (4.8)	25.7 (3.4)
OPHI-II Occupational Competence (pretest)	20.7 (2.6)	22.1 (2.3)
OPHI-II Occupational Behavior Settings (pretest)	20.7 (2.7)	21.6 (2.3)
OPHI-II Total score (posttest 2 weeks)	67.1 (8.3)	67.6 (7.3)
OPHI-II Occupational Identity (posttest 2 weeks)	25.3 (5.3)	25.0 (3.8)
OPHI-II Occupational Competence (posttest 2 weeks)	20.9 (2.7)	21.5 (2.0)
OPHI-II Occupational Behavior Settings (posttest 2 weeks)	20.9 (2.2)	21.1 (2.6)

Intervention Group vs Control Group: Mean Difference (Final Values): 3.2 (95% CI 1.65 to 5.55), p <0.001, Mixed Models Analysis
Intervention Group vs Control Group: Mean Difference (Final Values): 0.8 (95% CI 0.23 to 2.37), p = 0.019, Mixed Models Analysis
Intervention Group vs Control Group: Mean Difference (Final Values): 1.4 (95% CI 0.38 to 2.11), p = 0.006, Mixed Models Analysis

Population analysed: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: two weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Control Group	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23898928Lee J. Achieving best practice: a review of evidence linked to occupation-focused practice models. Occup Ther Health Care. 2010 Jul;24(3):206-22. doi: 10.3109/07380577.2010.483270.
Background: PubMed 18254437Lee SW, Taylor R, Kielhofner G, Fisher G. Theory use in practice: a national survey of therapists who use the Model of Human Occupation. Am J Occup Ther. 2008 Jan-Feb;62(1):106-17. doi: 10.5014/ajot.62.1.106.
Background: PubMed 22214401Lee SW, Kielhofner G, Morley M, Heasman D, Garnham M, Willis S, Parkinson S, Forsyth K, Melton J, Taylor RR. Impact of using the Model of Human Occupation: a survey of occupational therapy mental health practitioners' perceptions. Scand J Occup Ther. 2012 Sep;19(5):450-6. doi: 10.3109/11038128.2011.645553. Epub 2012 Jan 3.
Background: PubMed 23941371Melton J, Forsyth K, Metherall A, Robinson J, Hill J, Quick L. Program Redesign Based on the Model of Human Occupation: Inpatient Services for People Experiencing Acute Mental Illness in the UK. Occup Ther Health Care. 2008;22(2-3):37-50. doi: 10.1080/07380570801989382.
Individual participant dataSharing planned: No

Related trials for Occupational Therapy

Recruiting
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Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Recruiting
Structured Sensory-Based Occupational Therapy in Children With Autism
Autism Spectrum Disorder
Recruiting
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
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Not yet recruiting
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Not yet recruiting
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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.

Shu-Chun Lee, Master principal investigator

Department of Occupational Therapy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 24 Mar 2021. 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 Taiwan. 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?

Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Performance History Interview-II (OPHI-II) Total and Subscale Scores (time frame: 2 weeks). 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 NCT04465422, which also lists 4 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 24 Mar 2021.