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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014081
Receipt No. R000016392
Scientific Title The effect of a behavior activation program on improving mental and physical health complaints associated with radiaion stress among mothers in Fukushima.
Date of disclosure of the study information 2014/06/04
Last modified on 2016/12/05

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Basic information
Public title The effect of a behavior activation program on improving mental and physical health complaints associated with radiaion stress among mothers in Fukushima.
Acronym The effect of a behavior activation program improving radiation stress among mothers.
Scientific Title The effect of a behavior activation program on improving mental and physical health complaints associated with radiaion stress among mothers in Fukushima.
Scientific Title:Acronym The effect of a behavior activation program improving radiation stress among mothers.
Region
Japan

Condition
Condition Depression, Physical complaint
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of a behavior activation-based program for improving physical symptoms and psychological distress among mothers who have preschool children in Fukushima-city and surrounding or nearby region, with a randomized controlled trial design. The study also aimed to examine the effectiveness of this program for improving radiation stress, activity changes after the disaster, child-rearing anxiety, life satisfaction, and liveliness and boredom (derived from the Multiple Mood Scale), as secondary outcomes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Physical symptoms to be mesured by the Brief Job Stress Questionnaire at 3 and 6 months post-randomization.
2) Psychological distress to be measured by K6 at 3 and 6 months post-randomization.
Key secondary outcomes 1) Radiation stress: 7 items (Umeda et al, 2014)
2) Activity changes after the disaster: 9 items (original)
3) Liveliness and boredom: 20 items (the Multiple Mood Scale)
4) Child-rearing anxiety: 14items (the Child-rearing Anxiety Scale)
5) Life satisfaction: 1 item (visual analogue scale)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 A 2-session weekly on-site stress management program which provides psychoeducation of stress management skills based on the behavior activation technique.
Interventions/Control_2 Nothing for control group.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) mothers who have a preschool child.
2) living in Fukushima-city and surrounding or nearby region.
Key exclusion criteria A clinical psychologist in charge of the program judge that the participation in the program may cause a participant any health problem or worse a health problem which he/she already had.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norito Kawakami
Organization Graduate School of Medicine, University of Tokyo
Division name Mental Health
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-5841-3521
Email kawakami@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Sekiya
Organization Graduate School of Medicine, University of Tokyo
Division name Mental Health
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-5841-3364
Homepage URL
Email tomh@m.u-tokyo.ac.jp

Sponsor
Institute Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Ministry of the Environment
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 06 Month 04 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
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 Completed
Date of protocol fixation
2014 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2016 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016392

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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