UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014081 |
|---|---|
| Receipt number | 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 15:28:04 |
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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
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
tomh@m.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016392
