UMIN-CTR Clinical Trial

Basic information
Public title	Effect of interactive photo appreciation program on prevention of depression in older adults: a pilot randomized controlled trial
Acronym	Prevention of depression by interactive photo appreciation program
Scientific Title	Effect of interactive photo appreciation program on prevention of depression in older adults: a pilot randomized controlled trial
Scientific Title:Acronym	Prevention of depression by interactive photo appreciation program
Region	Japan

Condition
Condition	Healthy older adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the effects of interactive photo appreciation program on depressive symptom in older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Depression
Key secondary outcomes	Cognitive function Positive emotion Life satisfaction Psychological disorder Motivation Instrumental activities of daily living

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Interventions Interactive photo appreciation program, 3 months
Interventions/Control_2	Control Photo education by text, 3 months
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	84 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy older adults 2)Men and women aged from 65 to 84 years old 3)Persons who are independent of instrumental activities of daily living 4)Persons who give informed consent by document
Key exclusion criteria	1)Persons who are taking psychotropic drugs and anti-depressants(anti-anxiety drug and sleeping drug are excluded) 2)Persons who had cerebrovascular disease, myocardial infarction or angina attack within past six months 3)Persons with progressive diseases such as cancer and advanced visual impairment 4)Persons who are judged inappropriate for the intervention by the principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masumi Middle name Last name Ishihara
Organization	National Center for Geriatrics and Gerontology
Division name	Dept. Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430, Moriokamachi,Obu-shi,Aichi,474-8511 JAPAN
TEL	0562462311
Email	ishihara@ncgg.go.jp

Public contact
Name of contact person	1st name Masumi Middle name Last name Ishihara
Organization	National Center for Geriatrics and Gerontology
Division name	Dept. Social Science, Center for Gerontology and Social Science
Zip code	474-8511
Address	7-430, Moriokamachi,Obu-shi,Aichi,474-8511 JAPAN
TEL	0562462311
Homepage URL
Email	ishihara@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology Dept. Social Science, Center for Gerontology and Social Science
Institute
Department

Funding Source
Organization	Japan society for the promotion of science MEXTJapan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)	National Center for Geriatrics and Gerontology

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430 Morioka-cho, Obu, Aichi 4748511, Japan
Tel	0562-46-2311
Email	yaday@ncgg.go.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	国立研究開発法人　国立長寿医療研究センター（愛知県） National Center for Geriatrics and Gerontology（Aichi prefecture）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 21 Day

Related information
URL releasing protocol	N/A
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/1660-4601/15/7/1472/htm
Number of participants that the trial has enrolled	55
Results	Compared with the PCE(control) group, the CES-D score in the PPA(intervention) group significantly improved (main effect of group: t = -4.30, p < 0.001; interaction effect of group by time: t = 4.39, p < 0.001), with an effect size of d = 1.23.
Results date posted	2021 Year 05 Month 11 Day
Results Delayed
Results Delay Reason	Because the input to UMIN did not work.
Date of the first journal publication of results	2018 Year 07 Month 10 Day
Baseline Characteristics	Healthy older adults
Participant flow	We recruited 57 healthy Japanese community-dwelling older adults (38 women, aged 65-84 years) living in two municipalities; two were excluded due to illness, and 55 ultimately participated. Positive Photo Appreciation: PPA (intervention group, n = 28) or Photo Correspondence Education: PCE (control group, n = 27) were assigned to a 3-month pilot randomized controlled trial.
Adverse events	N/A
Outcome measures	the Center for Epidemiologic Studies Depression (CES-D) Scale the Kessler 6-item Psychological Distress Scale (K-6) the Apathy Scale the Satisfaction with Life Scale (SWLS) the Positive and Negative Affect Schedule (PANAS) Cognitive functions(NCGG-FAT)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 24 Day
Date of IRB	2017 Year 03 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 14 Day
Last follow-up date	2017 Year 07 Month 15 Day
Date of closure to data entry	2017 Year 07 Month 20 Day
Date trial data considered complete	2017 Year 07 Month 31 Day
Date analysis concluded	2017 Year 12 Month 20 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 20 Day
Last modified on	2021 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028071