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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040439
Receipt No. R000046139
Scientific Title Expressive writing to decrease rumination; A home-based intervention study for community-dwelling older adults
Date of disclosure of the study information 2020/05/18
Last modified on 2020/05/18

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Basic information
Public title Expressive writing to decrease rumination; A home-based intervention study for community-dwelling older adults
Acronym Home-based expressive writing intervention study for community-dwelling older adults
Scientific Title Expressive writing to decrease rumination; A home-based intervention study for community-dwelling older adults
Scientific Title:Acronym Home-based expressive writing intervention study for community-dwelling older adults
Region
Japan

Condition
Condition Community-dwelling older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We develop a home-based expressive writing to decrease rumination for community-dwelling older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Rumination
Key secondary outcomes Well-being

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The expressive writing group(intervention group) write about their stressful events for 15-30 minutes each day at home for a total duration of three times.
Interventions/Control_2 The active control group members are requested to recall what they bought the day before and write the name and prices of the items they bought.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria age 65 years and older
Key exclusion criteria with psychosis
Target sample size 84

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Fujiwara
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Social Participation and Community Health
Zip code 173-0015
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL 03-3964-3241
Email s_ogawa@tmig.or.jp

Public contact
Name of contact person
1st name Susumu
Middle name
Last name Ogawa
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Social Participation and Community Health
Zip code 173-0015
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL 03-3964-3241
Homepage URL
Email s_ogawa@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology Research Team for Social Participation and Community Health
Institute
Department

Funding Source
Organization The Ministry of Education,Culture,Sports,Science and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Metropolitan Institute of Gerontology
Address Research Team for Social Participation and Community Health
Tel 03-3964-3241
Email s_ogawa@tmig.or.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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 18 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 103
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Data have not been analyzed yet.
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 No longer recruiting
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
2014 Year 02 Month 24 Day
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046139

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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