Occupational Therapy, Psychiatric Rehabilitation
Conditions
Keywords
client-centered, Model of Human Occupation
Brief 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.
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.
Interventions
BEHAVIORALOccupational 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. 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.
BEHAVIORALOccupational therapy
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.
Sponsors
Taipei City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are blind during this clinical trial. They are prevented from having knowledge of the interventions.
Intervention model description
We will recruit 70 inpatients with schizophrenia and devided into intervention group, based on MOHO theory, and control group.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with schizophrenia according to DSM-5 diagnostic criteria. 2. Over 20 years old. 3. Agree to participate in the study
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occupational Therapy Evaluation Scales Measure | 2 weeks | 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) |
Countries
Taiwan
Participant flow
Recruitment details
Date of the recruitment period : 06/19/2020 - 07/16/2020 Recruitment type of location : medical clinical
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 16 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 9.4 | 43.5 years STANDARD_DEVIATION 9 | 43.6 years STANDARD_DEVIATION 9 |
| Duration of illness | 24.4 years STANDARD_DEVIATION 8.6 | 23.7 years STANDARD_DEVIATION 8.4 | 23.0 years STANDARD_DEVIATION 8.6 |
| Education College and above | 6 Participants | 15 Participants | 9 Participants |
| Education Junior high school | 3 Participants | 4 Participants | 1 Participants |
| Education Senior high school | 7 Participants | 14 Participants | 7 Participants |
| Marital Status Divorced | 1 Participants | 1 Participants | 0 Participants |
| Marital Status Married | 1 Participants | 3 Participants | 2 Participants |
| Marital Status Single | 14 Participants | 29 Participants | 15 Participants |
| Onset age | 19.0 years STANDARD_DEVIATION 3.8 | 19.56 years STANDARD_DEVIATION 4.29 | 20.1 years STANDARD_DEVIATION 4.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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).
Time frame: 2 weeks
Population: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Total score (pretest) | 66.2 score on a scale | Standard Deviation 8 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Identity (pretest) | 24.9 score on a scale | Standard Deviation 4.8 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Competence (pretest) | 20.7 score on a scale | Standard Deviation 2.6 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Behavior Settings (pretest) | 20.7 score on a scale | Standard Deviation 2.7 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Total score (posttest 2 weeks) | 67.1 score on a scale | Standard Deviation 8.3 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Identity (posttest 2 weeks) | 25.3 score on a scale | Standard Deviation 5.3 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Competence (posttest 2 weeks) | 20.9 score on a scale | Standard Deviation 2.7 |
| Intervention Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Behavior Settings (posttest 2 weeks) | 20.9 score on a scale | Standard Deviation 2.2 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Behavior Settings (posttest 2 weeks) | 21.1 score on a scale | Standard Deviation 2.6 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Total score (pretest) | 69.4 score on a scale | Standard Deviation 6.8 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Total score (posttest 2 weeks) | 67.6 score on a scale | Standard Deviation 7.3 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Identity (pretest) | 25.7 score on a scale | Standard Deviation 3.4 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Competence (posttest 2 weeks) | 21.5 score on a scale | Standard Deviation 2 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Competence (pretest) | 22.1 score on a scale | Standard Deviation 2.3 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Identity (posttest 2 weeks) | 25.0 score on a scale | Standard Deviation 3.8 |
| Control Group | Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores | OPHI-II Occupational Behavior Settings (pretest) | 21.6 score on a scale | Standard Deviation 2.3 |
Comparison: Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.p-value: <0.00195% CI: [1.65, 5.55]Mixed Models Analysis
Comparison: Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)p-value: 0.01995% CI: [0.23, 2.37]Mixed Models Analysis
Comparison: Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.p-value: 0.00695% CI: [0.38, 2.11]Mixed Models Analysis
Comparison: Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.p-value: 0.13695% CI: [-0.19, 1.35]Mixed Models Analysis
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: 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)
Time frame: 2 weeks
Population: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Occupational Therapy Evaluation Scales Measure | LIADL(pretest) | 18.1 score on a scale | Standard Deviation 4.8 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | CGIS(posttest 2 weeks) | 3.6 score on a scale | Standard Deviation 1 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COPM-C performance(pretest) | 5.7 score on a scale | Standard Deviation 2.6 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | LIADL(posttest 2 weeks) | 18.2 score on a scale | Standard Deviation 4.3 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | CGIS(pretest) | 3.9 score on a scale | Standard Deviation 0.8 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COTES(posttest 2 weeks) | 71.9 score on a scale | Standard Deviation 7.1 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COPM-C satisfaction(pretest) | 5.5 score on a scale | Standard Deviation 2.9 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COPM-C performance(posttest 2 weeks) | 6.2 score on a scale | Standard Deviation 2.5 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COTES(pretest) | 70.8 score on a scale | Standard Deviation 7.9 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | COPM-C satisfaction(posttest 2 weeks) | 6.2 score on a scale | Standard Deviation 2.6 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | PSP(pretest) | 52.1 score on a scale | Standard Deviation 15.9 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | PSP(posttest 2 weeks) | 53.4 score on a scale | Standard Deviation 15.4 |
| Intervention Group | Occupational Therapy Evaluation Scales Measure | MMSE(pretest) | 27.5 score on a scale | Standard Deviation 2.5 |
| Control Group | Occupational Therapy Evaluation Scales Measure | PSP(posttest 2 weeks) | 55.4 score on a scale | Standard Deviation 11.3 |
| Control Group | Occupational Therapy Evaluation Scales Measure | MMSE(pretest) | 27.8 score on a scale | Standard Deviation 2.5 |
| Control Group | Occupational Therapy Evaluation Scales Measure | CGIS(pretest) | 4.0 score on a scale | Standard Deviation 0.9 |
| Control Group | Occupational Therapy Evaluation Scales Measure | LIADL(pretest) | 17.8 score on a scale | Standard Deviation 4.2 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COTES(pretest) | 74.9 score on a scale | Standard Deviation 7.8 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COPM-C performance(pretest) | 5.1 score on a scale | Standard Deviation 2.3 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COPM-C satisfaction(pretest) | 4.8 score on a scale | Standard Deviation 2.5 |
| Control Group | Occupational Therapy Evaluation Scales Measure | PSP(pretest) | 51.9 score on a scale | Standard Deviation 12.5 |
| Control Group | Occupational Therapy Evaluation Scales Measure | CGIS(posttest 2 weeks) | 3.4 score on a scale | Standard Deviation 1 |
| Control Group | Occupational Therapy Evaluation Scales Measure | LIADL(posttest 2 weeks) | 18.6 score on a scale | Standard Deviation 3 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COTES(posttest 2 weeks) | 74.3 score on a scale | Standard Deviation 8.6 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COPM-C performance(posttest 2 weeks) | 5.1 score on a scale | Standard Deviation 2.3 |
| Control Group | Occupational Therapy Evaluation Scales Measure | COPM-C satisfaction(posttest 2 weeks) | 4.7 score on a scale | Standard Deviation 2.4 |
Comparison: Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.p-value: 0.59295% CI: [-3.9, 2.25]Mixed Models Analysis
Comparison: Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.p-value: 0.30295% CI: [-2.29, 7.23]Mixed Models Analysis
Comparison: Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.p-value: 0.93195% CI: [-6.25, 6.82]Mixed Models Analysis
Comparison: Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.p-value: 0.98195% CI: [-1.73, 1.69]Mixed Models Analysis