Development and Validation of the Client Centered Occupational Therapy Service Model

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.

Study Overview

• Status: Completed
• Conditions: Occupational Therapy; Psychiatric Rehabilitation
• Intervention / Treatment: Behavioral: Occupational therapy based on the MOHO theory; Behavioral: Occupational therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110209
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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, 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.	Behavioral: 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. 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.
Active Comparator: Control 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, 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.	Behavioral: Occupational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: Mini-Menlal State Examination, MMSE(range 0~30；the higher scores indicate greater ability); Canadian Occupational Performance Measure, COPM(performance and satisfaction, each range 1~10；the higher scores indicate greater performance); Personal and Social Performance scale , PSP(range 1~100；the higher scores indicate greater performance); Clinical Global Impressions Scale of Severity, CGIS(range 1~7；the lower scores indicate greater performance); Comprehensive Occupational Therapy Evaluation Scale, COTES(range 20~100；the higher scores indicate greater performance); Lawton Instrumental Activities Daily Living, LIADL(range 0~23；the higher scores indicate greater performance)	2 weeks

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Principal Investigator: Shu-Chun Lee, Master, Department of Occupational Therapy

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 16, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Model of Human Occupation; client-centered
• Other Study ID Numbers: TCHIRB-10904021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No