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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036104
Receipt No. R000041129
Scientific Title Research on effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Date of disclosure of the study information 2019/03/06
Last modified on 2019/03/06

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Basic information
Public title Research on effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Acronym Research on effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Scientific Title Research on effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Scientific Title:Acronym Research on effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Region
Japan

Condition
Condition Japanese cancer patients with depression
Classification by specialty
Medicine in general Psychiatry Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this research is to evaluate the effectiveness of behavioral activation therapy for Japanese cancer patients with depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission rate of depression based on Hamilton Rating Scale for depression
Key secondary outcomes Beck Depression Inventory-2
Generalized Anxiety Disorder-7
Functional Assessment of Cancer Therapy-General
Behavioral Activation for Depression Scale-Short Form
Valuing Questionnaire
Reward Probability Index
Completion rate of the intervention program
Questionnaires before and after the intervention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The intervention program consisted of seven 50-minute sessions conducted over 1 or 2 weeks, with an average of 5 to 10 minutes of homework per day.
Interventions/Control_2
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 Male and Female
Key inclusion criteria Somatic disease: patients whose prognosis is expected for more than 1 year
Mental disorders: meet the diagnosis criteria for major depression episode by
Mini-International Neuropsychiatric Interview(M.I.N.I.)
Severity of mental disorders: more than 8 points in HRSD (depressive severity at
mild and above levels)
Age: over 20(patients aged 65 and older must have at least 24 points with MMSE.)
PS: 0-1 by ECOG performance status score
Language: capable of Japanese
Assent: obtain assent for taking part in the research in writing
Key exclusion criteria they show either serious physical or mental symptoms (cognitive functional disorders,disturbance of consciousness, depressive conditions accompanied with psychiatric symptoms, imminent suicidal ideation, and/or record of contemplation of suicide)
they have experienced intervention by experts in the past such as behavioral activation therapy
the physicians in charge judge it difficult for their patients to participate in the program
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Hirayama
Organization National Cancer Center Hospital, Japan
Division name Department of Psycho-Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email thirayam@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Hirayama
Organization National Cancer Center Hospital, Japan
Division name Department of Psycho-Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL https://www.ncc.go.jp/jp/ncch/clinic/psycho-oncology/consultation/tokushu_gairai/030/20171125131648.
Email thirayam@ncc.go.jp

Sponsor
Institute Department of Psycho-Oncology, National Cancer Center Hospital, Japan
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Human Sciences, Waseda University
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
2019 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 21 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
2019 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041129

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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