UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of long-term intervention of positive occupation-based practices that promote well-being: A quasi-experimental validation using the engagement estimation system of assessment of positive occupation-15.
Acronym	Testing the Effectiveness of Occupational Therapy Practices to Promote Well-Being Using the APO-15 Estimation System: A Quasi-Experimental Validation
Scientific Title	Examining the effectiveness of positive occupation-based practices using the APO-15 estimation system: A quasi-experimental study
Scientific Title:Acronym	Effectiveness of POBP using the APO-15 estimation system: a quasi-experimental study
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to quasi-experimentally examine the effects of a long-term intervention of POBP using the APO-15 estimation system in users of occupational therapy in psychiatric daycare and hospitals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Positive and Negative Affect Schedule (PANAS) Assessment period: baseline, post-intervention (after 5 months), post-follow-up (after 1 month)
Key secondary outcomes	1) Assessment of Positive Occupation 15 (APO-15) 2) Subjective Happiness Scale (SHS) 3) Life Assessment Scale for the Mentally Ill (LASMI)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention will be conducted by adding positive occupation-based practice (POBP) to the regular occupational therapy program (daycare program) conducted at each facility (5 months). After the intervention, a follow-up period (1 month) is planned to ensure that the effects of the intervention are sustained. The frequency of POBP intervention should be at least once a week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) those who have been diagnosed by a physician as having a psychiatric disorder such as schizophrenia and have been treated for at least one year, 2) those who are between 20 and 80 years of age, 3) those whose evaluation results by the APO-15 estimation system are in the range of rank 1 to 4, 4) those who understand the contents of the study and are able to consent to participation, 5) those whose medical conditions are relatively stable and who are judged to be able to cooperate in this study based on the judgment of their attending physician.
Key exclusion criteria	1) Those whose condition is unstable and who are judged by their attending physician or others to be unable to participate in this study to the end, 2) Those whose age is less than 20 years or more than 81 years, 3) Those whose evaluation result by the APO-15 estimation system is rank 5, 4) Those who do not consent to this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Noguchi
Organization	Zikei Hospital
Division name	Occupational Therapy Section
Zip code	702-8026
Address	100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
TEL	086-262-1191
Email	ngc_1557_ngc@chic.ocn.ne.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Noguchi
Organization	Zikei Hospital
Division name	Occupational Therapy Section
Zip code	702-8026
Address	100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
TEL	086-262-1191
Homepage URL
Email	ngc_1557_ngc@chic.ocn.ne.jp

Sponsor
Institute	Zikei Hospital
Institute
Department

Funding Source
Organization	Japan Association of Occupational Therapists
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Zikei Hospital
Address	100-2, Urayasu Honmachi, Minami-ku, Okayama City, Okayama Prefecture
Tel	086-262-1191
Email	ngc_1557_ngc@chic.ocn.ne.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	慈圭病院（岡山県），河口医院（岡山県），倉敷神経科病院（岡山県），医王ヶ丘病院（石川県），田宮病院（新潟県）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2022 Year 02 Month 01 Day
Date of IRB	2022 Year 02 Month 01 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2022 Year 11 Month 01 Day
Date of closure to data entry	2022 Year 12 Month 01 Day
Date trial data considered complete	2022 Year 12 Month 01 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 02 Month 26 Day
Last modified on	2022 Year 11 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053639