UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024501 |
|---|---|
| Receipt number | R000028071 |
| Scientific Title | Effect of interactive photo appreciation program on prevention of depression in older adults: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2016/10/21 |
| Last modified on | 2021/05/11 14:57:44 |
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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
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
ishihara@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Dept. Social Science, Center for Gerontology and Social Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028071
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
