UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of a behavior activation program on improving mental and physical health complaints associated with radiaion stress among mothers in Fukushima.
Title of the study (Brief title)	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	Norito Kawakami
Organization	Graduate School of Medicine, University of Tokyo
Division name	Mental Health
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	Yuki Sekiya
Organization	Graduate School of Medicine, University of Tokyo
Division name	Mental Health
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016392