Development and Validation of the Client Centered Occupational Therapy Service Model
Phase: NA
Conditions: Occupational Therapy, Psychiatric Rehabilitation
Sponsor: Taipei City Hospital

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Development and validation of the Client centered 
Occupational Therapy service model 
 
 
 
 
 
 
 
 
 
ClinicalTrials.gov ID: NCT04465422 
 
Version Date: 11.13.2020 
 
Protocol ID: TCHIRB-10904021 
Principal Investigator(s):  
Shu-Chun Lee, Master 
En-Chi Chiu, PhD 
 

Background and Significance 
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.  
 
Specific Aims 
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. 
 
Research Design and Methods 
Participants who met the inclusion criteria and signed the informed consent were 
assessed twice, 2 weeks apart, by an occupational therapist in a quiet environment. 
After the assessment, participants were randomized into two groups in a blinded 
one-to-one fashion. This project consists of 2 stages. First, based on the MOHO 
model we use 6 courses with 2 weeks program to develop the OT@tcpc service model. 
Second, validate two 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. The Intervention 
group provided Occupational therapy based on the MOHO theory, while the control 
group adopted the original Occupational therapy model. 
 
Participants: 
Individuals with schizophrenia were recruited from the Songde District of Taipei City 
Hospital in Taiwan in June 2020. 
Inclusion Criteria: 
1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria. 
2. Aged 20 or older 
3. Agree to participate in the study and provide a signed informed consent form 

(ICF) 
Exclusion Criteria: 
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 
 
The first patient was included in the study June 2020 and the last patient exited the 
study in July 2020. The recruitment period was one week. The trial was conducted at 
Songde District of Taipei City Hospital in Taiwan.A total of 35 patients were screened 
(Fig 1). The planned study period was 1 month. The trial was designed according to 
Fig 2.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fig1. Patient flow. The outline of the selection and randomization flow of patients in the study. 
Assessed for eligibility (n=35) 
Excluded (n=2) 
• 
Declined to paritcipate (n=1) 
• 
Not meeting inclusion criteria (n=1)  
Randomized (n=33) 
Allocated to Intervention Group (n=17 ) 
  Received allocated intervention (n=17 ) 
  Did not received allocated intervention 
(n= 0 ) 
Allocated to Control Group (n= 16 ) 
  Received allocated intervention (n= 14 ) 
  Did not received allocated intervention 
(n= 2) 
Lost to follow-up (early termination)(n= 0 ) 
Discontinued intervention (early termination)(n= 0) 
Lost to follow-up (early termination)(n= 2 ) 
Discontinued intervention (early termination)(n= 0) 
Analyzed intent to treat  (n= 17 ) 
  Excluded from analysis (lack of post 
baseline assessments) (n= 0 ) 
Analyzed intent to treat  (n= 14 ) 
  Excluded from analysis (lack of post 
baseline assessments) (n= 2 ) 
Allocation 
Follow-Up 
Analysis 

 
 
 
 
 
 
 
 
 
 
Fig 2. Trial design. Patients with chronic schizophrenia were randomized to the two treatment arms at 
the Baseline. 
 
Statistical methods: 
Descriptive summary statistics or frequency counts of demographic and baseline 
data were presented by treatment arm and overall for the intent to treat (ITT) and per 
protocol (PP) populations. The PP population was defined as individuals who had 
completed all scheduled study visits, while the ITT referred to those with data from at 
least two study visits. 
 
Statistical Analysis 
A total of 35 patients were screened for participation in the study. One group of 
16 people participated in the control group, and the other 17 people paricipeted in the 
intervention group. In the sample for Intervention group, the mean age was 43.6 years 
(SD 9.0), and 64.7% of the participants were male. The average duration of illness 
was 23 years. In the sample for control group, 50% of the participants were also male, 
the mean age was 43,4 years (SD 9.4), and the average duration of illness was 24.4 
years. These two groups were similar in terms of age, onset age, duration of illness, 
gender, education and marriage. Table 1 presents further details of the participants. 
 
Measure 
Intervention 
group (n=17) 
Control group 
(n=16) 
p value 
 N (%), Mean ± SD 
Demographic characteristics 
 
 
 
Age (years) 
43.6 ± 9.0 
43.4 ± 9.4 
0.93 
Onset age (years) 
20.1 ± 4.8 
19.0 ± 3.8 
0.47 
Duration of illness (years) 
23.0 ± 8.6 
24.4 ± 8.6 
0.65 
Patients with  
chronic 
schizophrenia  
Baseline ； 
1st test  
2 weeks；
Intervention  
2nd test 
RANDOMISATION  
ARM 1 : Intervention Group 
ARM 2 : Control Group 

Gender 
 
 
0.49 
Male 
11 (64.7%) 
8 (50.0%) 
 
Female 
6 (35.3%) 
8 (50.0%) 
 
Education 
 
0.46 
Junior high school  
1 (5.9%) 
3 (18.8%) 
Senior high school 
7 (41.2%) 
7 (43.8%) 
College and above 
9 (52.9%) 
6 (37.4%) 
Marriage 
 
0.51 
Single 
15 (88.2%) 
14 (87.5%) 
Married 
2 (11.8%) 
1 (6.3%) 
Divorced 
0 (0.0%) 
1 (6.3%) 
Medical characteristics 
 
 
 
MMSE 
27.5 ± 2.5 
27.8 ± 2.5 
0.80 
CGIS  
3.6 ± 1.2 
3.4 ± 1.6 
0.58 
LIADL 
18.1 ± 4.8 
17.8 ± 4.2 
0.88 
COTES 
70.8 ± 7.9 
74.9 ± 7.8 
0.14 
COPM-C 
11.3 ± 5.4 
9.9 ± 4.6 
COPM-C performance 
5.7 ± 2.6 
5.1 ± 2.3 
 
COPM-C satisfaction 
5.6 ± 3.0 
4.8 ± 2.5 
 
PSP 
52.1 ± 15.9 
51.9 ± 12.5 
0.97 
Socially useful activities 
2.5 ± 1.5 
2.3 ± 1.1 
Personal and social 
relationships 
3.9 ± 1.3 
4.3 ± 1.0 
 
Self-care 
1.4 ± 0.7 
1.4 ± 0.7 
Disturbing and aggressive 
behaviors 
1.3 ± 0.5 
1.4 ± 0.5 
 
OPHI-II 
66.2 ± 8.0 
69.4 ± 6.8 
0.24 
Occupational Identity 
24.9 ± 4.8 
25.7 ± 3.4 
0.58 
Occupational Competence 
20.7 ± 2.6 
22.1 ± 2.7 
0.13 
Occupational Behavior 
Settings 
20.7 ± 2.7 
21.6 ± 2.3 
0.28 
Table 1. Demographic and medical characteristics for the two treatment groups. 
The sample statistics presented in this table were mean ± standard deviation (SD) for 
continuous variables and frequency (percentage, %) for categorical variables. The 
listed p-values of statistical tests were calculated using the Wilcoxon rank-sum test for 
continuous variables and the Fisher’s exact test for categorical variables. 
 
 

References: 
1. 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. 
2. 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. 
3. 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. 
4. 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. 
5. Landtblom, A. M., Guala, D., Martin, C., Olsson-Hau, S., Haghighi, S., Jansson, L., 
& Fredrikson, S. (2019). RebiQoL: A randomized trial of telemedicine patient 
support program for health-related quality of life and adherence in people with MS 
treated with Rebif. PloS one, 14(7), e0218453. 
6. 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. Occupational therapy in health care. 
2008;22:37-50 
7. Liu KP, Ng BF. Usefulness of the model of human occupation in the hong kong 
chinese context. Occupational therapy in health care. 2008;22:25-36 
8. Costa A, Othero M. Palliative care, terminal illness, and the model of human 
occupation. Physical & Occupational Therapy in Geriatrics. 2012;30:316-327