UMIN-CTR Clinical Trial

Basic information
Public title	An intervention study to elucidate the relationship between the causes and psychological effects of lifelong nostalgic memories
Acronym	The relationship between the causes and psychological effects of nostalgic memories
Scientific Title	An intervention study to elucidate the relationship between the causes and psychological effects of lifelong nostalgic memories
Scientific Title:Acronym	The relationship between the causes and psychological effects of nostalgic memories
Region	Japan

Condition
Condition	healthy older adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the "reasons" for feeling nostalgic about memories of various periods of life (childhood, around age 20, etc.) in healthy elderly people, and to clarify the relationship between these "reasons" and the psychological effects (self-esteem, sense of social connectedness, etc.) of recalling nostalgic memories. Furthermore, to clarify whether the "reasons" and "effects" of nostalgic memories differ depending on the age of recall.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factor scores for the nostalgic reasons factor
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	recollection of nostalgic memories (once, about 5 minutes)
Interventions/Control_2	recollections of everyday events (once, about 5 minutes)
Interventions/Control_3	recollections of lucky events (once, about 5 minutes)
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	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Age 60 and over Male/Female
Key exclusion criteria	History or current history of psychiatric or neurological disorders
Target sample size	2210

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Oba
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Zip code	9908575
Address	4-1 Seiryo-machi Aobaku, Sendai
TEL	0227178563
Email	kentaro.oba.c6@tohoku.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Oba
Organization	Tohoku University
Division name	Institute of Development, Aging and Cancer
Zip code	9808575
Address	4-1 Seiryo-machi Aobaku, Sendai
TEL	0227178563
Homepage URL
Email	kentaro.oba.c6@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 22 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	2022 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2023 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	2022 Year 06 Month 22 Day
Last modified on	2022 Year 06 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054852