UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040439
Receipt number 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 2024/03/19 18:45:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

103

Results

Twenty-six participants were included in the final analysis. The results showed that rumination, a risk factor for depression, decreased in the active control group compared to the expressive writing group. Our findings suggest that older adults can efficiently perform writing sessions at home. Also, a task such as cognitive training, rather than writing about stressful events, decreased rumination in older adults concerned about their forgetfulness.

Results date posted

2024 Year 03 Month 19 Day

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

Completed

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

2024 Year 03 Month 19 Day



Link to view the page

Value
https://center6.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