UMIN-CTR Clinical Trial

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

Depression, Physical complaint

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Ministry of the Environment

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

06

Month

04

Day

URL releasing protocol

Publication of results

Published

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

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 related 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