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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038891
Receipt No. R000044346
Scientific Title Motivational interviewing for sedentary behaviour to reduce cardiovascular risk in people with schizophrenia: a pilot feasibility study
Date of disclosure of the study information 2019/12/16
Last modified on 2019/12/16

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Basic information
Public title Motivational interviewing for sedentary behaviour to reduce cardiovascular risk in people with schizophrenia: a pilot feasibility study
Acronym Motivational interviewing for sedentary behaviour to reduce cardiovascular risk in people with schizophrenia: a pilot feasibility study
Scientific Title Motivational interviewing for sedentary behaviour to reduce cardiovascular risk in people with schizophrenia: a pilot feasibility study
Scientific Title:Acronym Motivational interviewing for sedentary behaviour to reduce cardiovascular risk in people with schizophrenia: a pilot feasibility study
Region
Japan

Condition
Condition schizophrenia and related disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess feasibility, safety, and efficacy of newly developed motivational interviewing for people with schizophrenia who have increased sedentary time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objectively-measured sedentary time (min/day) using accelerometer at one month post intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Two sessions of motivational interviewing newly developed for people with schizophrenia who have increased sedentary time. One session lasts about 30 minutes and there should be no more than one week between the sessions.
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
65 years-old >
Gender Male and Female
Key inclusion criteria - Aged 20 years or older and less than 65 yeas
- Males and females
- Diagnosed as one of schizophrenia and related disorders according to ICD-10 as follows: schizophrenia (F20), schizotypal disorder (F21), delusional disorder (F22), shared psychotic disorder (F23), or schizoaffective disorder (F25). Diagnosis is confirmed by both of a) reviewing a diagnosis recorded in a chart, and b) a psychiatrist other than one who made the diagnosis agreeing the diagnosis by either reviewing detailed symptomtology recorded in participant's chart or asking directly to the participant after permission from both the participant and his/her doctor.
- Having more than or equal to 6 hours of sedentary time which is self-reported in the question 4a of the International Physical Activity Questionnaire - short form (IPAQ-SF)
- Scored less than 45 out of 112 in the Brief Psychiatric Rating Scale(BPRS)
- Having no psychiatric admission past six months (in case of outpatient participants)
- Visiting participant's doctor regularly (in case of outpatient participants)
- Understanding the Janapese language
- Having very low risk of suicide at the time of recruitment assesed by participant's doctor or nurse, or the investigator of this study
- Not contraindicated, by participant's doctor, to receiving motivational interviewing
- Able to wear an accelerometer as indicated.
Key exclusion criteria - Diagnosed asor suspeced of substance use disorder or having past history of the disorder except for smoking cigarettes.
- Diagnosed as or suspected of attention deficit hyperactivity disorder, as hyperactivity might overestimate physical activity.
- Diagnosed as or suspected of autism spectrum disorder, as its repeated movements might overestimate physical activity.
- Diagnosed as or suspected of any other develpmental disorders that might interfere with motivational interviewing, as assesed by participant's doctor.
- Diagnosed as any physical illnesses that might interfere with the brain function, including dementia and any brain damage that caused loss of consciousness.
- Diagnosed as moderate, severe, or most severe intellectual disability (equivalent to F71, F72, or F73 in ICD-10).
- Under the care of guardianship.
- In the manic or hypomanic state at the time of recruitment, as the symptom might overestimate physical activity, assessed by the participant's doctor or the investigator of this study.
- In the moderate or severe depressive state at the time of recruitment, as the symptom might underestimate physical activity, assessed by the participant's doctor or the investigator of this study.
- Having akathisia by participant's doctor or the investigator of this suty visually inspecting the participant as the symptom might overestimate physical activity.
- Contraindicated to receiving motivational interviewing by any reason as assessed by the participant's doctor or the investigator of this study.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Watanabe
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behaviour
Zip code 606-8501
Address Yoshidakonoecho, Sakyo-ku, Kyoto
TEL 075-753-9491
Email watanabe.norio.6x@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Sato
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behaviour
Zip code 606-8501
Address Yoshidakonoecho, Sakyo-ku, Kyoto
TEL 075-753-9491
Homepage URL
Email sato.akira.57m@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Self-funded
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Iwate Prefectural Nanko Hospital, Urawa Shinkei Sanatorium
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.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 岩手県立南光病院(岩手県)、医療法人白翔会 浦和神経サナトリウム(埼玉県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 16 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
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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2022 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 15 Day
Last modified on
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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