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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational therapy based on the MOHO theory | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-Chun Lee, Master | Department of Occupational Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Hospital | Taipei | 110209 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23898928 | Background | 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. | |
| 18254437 | Background | 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. |
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Date of the recruitment period : 06/19/2020 - 07/16/2020 Recruitment type of location : medical clinical
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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. Occupational therapy based on the MOHO theory: 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. |
| FG001 | Control Group | We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory. Occupational therapy based on the MOHO theory: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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two weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The Intervention group provided Occupational therapy based on the MOHO theory. Occupational therapy based on the MOHO theory: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shu Chun Lee | Taipei City Hospital | +886 2 27263141 | 1004 | A1057@tpech.gov.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2020 | Dec 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.
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Participants are blind during this clinical trial. They are prevented from having knowledge of the interventions.
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| Occupational therapy | Behavioral | 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. |
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| 2 weeks |
| 22214401 | Background | 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. |
| 23941371 | Background | 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. |
| BG001 | Control Group | In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Onset age | Mean | Standard Deviation | years |
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| Duration of illness | Mean | Standard Deviation | years |
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| Marital Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| OG000 | Intervention Group | 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. Occupational therapy based on the MOHO theory: 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. |
| OG001 | Control Group | We will recruit 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. Execution for two weeks. 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. |
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| Secondary | 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:
| Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control Group | In order to indicate the occupation identity and competence to validate the OT@tcpc service model. We recruited 70 inpatients with schizophrenia and divided into intervention group and control group. The control group adopted the original Occupational therapy model. 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D013812 |
| Therapeutics |
| Divorced |
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| College and above |
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| LIADL(pretest) |
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| COTES(pretest) |
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| COPM-C performance(pretest) |
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| COPM-C satisfaction(pretest) |
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| PSP(pretest) |
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| CGIS(posttest 2 weeks) |
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| LIADL(posttest 2 weeks) |
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| COTES(posttest 2 weeks) |
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| COPM-C performance(posttest 2 weeks) |
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| COPM-C satisfaction(posttest 2 weeks) |
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| PSP(posttest 2 weeks) |
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Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20~100；the higher scores indicate greater performance) total scores. |
| Mixed Models Analysis |
| 0.302 |
| Mean Difference (Final Values) |
| 4.1 |
| Standard Error of the Mean |
| 2.37 |
| 2-Sided |
| 95 |
| -2.29 |
| 7.23 |
| Superiority |
| Statistical Analysis 3 is based on Personal and Social Performance scale (range 1~100；the higher scores indicate greater performance) total scores. | Mixed Models Analysis | 0.931 | Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 3.25 | 2-Sided | 95 | -6.25 | 6.82 | Superiority |
| Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1~10；the higher scores indicate greater performance) total scores. | Mixed Models Analysis | 0.981 | Mean Difference (Final Values) | -1.4 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | -1.73 | 1.69 | Superiority |