Trial Outcomes & Findings for Development and Validation of the Client Centered Occupational Therapy Service Model (NCT NCT04465422)
NCT ID: NCT04465422
Last Updated: 2021-03-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-03-24
Participant Flow
Date of the recruitment period : 06/19/2020 - 07/16/2020 Recruitment type of location : medical clinical
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=17 Participants
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.
|
Control Group
n=16 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 9 • n=17 Participants
|
43.4 years
STANDARD_DEVIATION 9.4 • n=16 Participants
|
43.5 years
STANDARD_DEVIATION 9 • n=33 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
19 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
14 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Onset age
|
20.1 years
STANDARD_DEVIATION 4.8 • n=17 Participants
|
19.0 years
STANDARD_DEVIATION 3.8 • n=16 Participants
|
19.56 years
STANDARD_DEVIATION 4.29 • n=33 Participants
|
|
Duration of illness
|
23.0 years
STANDARD_DEVIATION 8.6 • n=17 Participants
|
24.4 years
STANDARD_DEVIATION 8.6 • n=16 Participants
|
23.7 years
STANDARD_DEVIATION 8.4 • n=33 Participants
|
|
Marital Status
Single
|
15 Participants
n=17 Participants
|
14 Participants
n=16 Participants
|
29 Participants
n=33 Participants
|
|
Marital Status
Married
|
2 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=33 Participants
|
|
Marital Status
Divorced
|
0 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=33 Participants
|
|
Education
Junior high school
|
1 Participants
n=17 Participants
|
3 Participants
n=16 Participants
|
4 Participants
n=33 Participants
|
|
Education
Senior high school
|
7 Participants
n=17 Participants
|
7 Participants
n=16 Participants
|
14 Participants
n=33 Participants
|
|
Education
College and above
|
9 Participants
n=17 Participants
|
6 Participants
n=16 Participants
|
15 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.
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).
Outcome measures
| Measure |
Intervention Group
n=17 Participants
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.
|
Control Group
n=16 Participants
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.
|
|---|---|---|
|
Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores
OPHI-II Total score (pretest)
|
66.2 score on a scale
Standard Deviation 8.0
|
69.4 score on a scale
Standard Deviation 6.8
|
|
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
|
25.7 score on a scale
Standard Deviation 3.4
|
|
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
|
22.1 score on a scale
Standard Deviation 2.3
|
|
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
|
21.6 score on a scale
Standard Deviation 2.3
|
|
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
|
67.6 score on a scale
Standard Deviation 7.3
|
|
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
|
25.0 score on a scale
Standard Deviation 3.8
|
|
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
|
21.5 score on a scale
Standard Deviation 2.0
|
|
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
|
21.1 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.
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)
Outcome measures
| Measure |
Intervention Group
n=17 Participants
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.
|
Control Group
n=16 Participants
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.
|
|---|---|---|
|
Occupational Therapy Evaluation Scales Measure
MMSE(pretest)
|
27.5 score on a scale
Standard Deviation 2.5
|
27.8 score on a scale
Standard Deviation 2.5
|
|
Occupational Therapy Evaluation Scales Measure
CGIS(pretest)
|
3.9 score on a scale
Standard Deviation 0.8
|
4.0 score on a scale
Standard Deviation 0.9
|
|
Occupational Therapy Evaluation Scales Measure
LIADL(pretest)
|
18.1 score on a scale
Standard Deviation 4.8
|
17.8 score on a scale
Standard Deviation 4.2
|
|
Occupational Therapy Evaluation Scales Measure
COTES(pretest)
|
70.8 score on a scale
Standard Deviation 7.9
|
74.9 score on a scale
Standard Deviation 7.8
|
|
Occupational Therapy Evaluation Scales Measure
COPM-C performance(pretest)
|
5.7 score on a scale
Standard Deviation 2.6
|
5.1 score on a scale
Standard Deviation 2.3
|
|
Occupational Therapy Evaluation Scales Measure
COPM-C satisfaction(pretest)
|
5.5 score on a scale
Standard Deviation 2.9
|
4.8 score on a scale
Standard Deviation 2.5
|
|
Occupational Therapy Evaluation Scales Measure
PSP(pretest)
|
52.1 score on a scale
Standard Deviation 15.9
|
51.9 score on a scale
Standard Deviation 12.5
|
|
Occupational Therapy Evaluation Scales Measure
CGIS(posttest 2 weeks)
|
3.6 score on a scale
Standard Deviation 1.0
|
3.4 score on a scale
Standard Deviation 1.0
|
|
Occupational Therapy Evaluation Scales Measure
LIADL(posttest 2 weeks)
|
18.2 score on a scale
Standard Deviation 4.3
|
18.6 score on a scale
Standard Deviation 3.0
|
|
Occupational Therapy Evaluation Scales Measure
COTES(posttest 2 weeks)
|
71.9 score on a scale
Standard Deviation 7.1
|
74.3 score on a scale
Standard Deviation 8.6
|
|
Occupational Therapy Evaluation Scales Measure
COPM-C performance(posttest 2 weeks)
|
6.2 score on a scale
Standard Deviation 2.5
|
5.1 score on a scale
Standard Deviation 2.3
|
|
Occupational Therapy Evaluation Scales Measure
COPM-C satisfaction(posttest 2 weeks)
|
6.2 score on a scale
Standard Deviation 2.6
|
4.7 score on a scale
Standard Deviation 2.4
|
|
Occupational Therapy Evaluation Scales Measure
PSP(posttest 2 weeks)
|
53.4 score on a scale
Standard Deviation 15.4
|
55.4 score on a scale
Standard Deviation 11.3
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place