UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038891 |
|---|---|
| Receipt number | 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 | 2020/11/19 20:01:27 |
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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
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
sato.akira.57m@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
4
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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 15 | Day |
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
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044346
