UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036104
Receipt number 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 2023/09/08 16:34:44

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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

65 years-old >

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 Takatoshi
Middle name
Last name Hirayama

Organization

National Cancer Center Hospital, Japan

Division name

Department of Psycho-Oncology

Zip code

1040045

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 Takatoshi
Middle name
Last name Hirayama

Organization

National Cancer Center Hospital, Japan

Division name

Department of Psycho-Oncology

Zip code

1040045

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/index.html

Email

thirayam@ncc.go.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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

National Cancer Center IRB office

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp


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

国立がん研究センター中央病院


Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 06 Day


Related information

URL releasing protocol

https://www.liebertpub.com/doi/10.1089/pmr.2023.0020

Publication of results

Published


Result

URL related to results and publications

https://www.liebertpub.com/doi/10.1089/pmr.2023.0020

Number of participants that the trial has enrolled

32

Results

The completion rate was 75% (24/32), which was similar to previous studies. The total HAMD17 score significantly improved after the program. The remission rate of depression was 62.5% (20/32), which was above the defined threshold value (30%). All but two secondary outcomes significantly improved after the program (p < 0.05). The feasibility and preliminary effectiveness of BA for patients with cancer and depression in Japan were suggested.

Results date posted

2023 Year 09 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with Cancer and Depression

Participant flow

Of the 68 patients recruited from February 2018 to January 2022, 32 were registered.

Adverse events

None

Outcome measures

the 17-item version of the GRID Hamilton Rating Scale for Depression (HAMD17)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 01 Month 31 Day

Date of IRB

2018 Year 02 Month 09 Day

Anticipated trial start date

2018 Year 02 Month 21 Day

Last follow-up date

2022 Year 01 Month 11 Day

Date of closure to data entry

2022 Year 01 Month 31 Day

Date trial data considered complete

2022 Year 02 Month 14 Day

Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information

An article on the study's findings is published in Palliative Medicine Reports. https://www.liebertpub.com/doi/10.1089/pmr.2023.0020


Management information

Registered date

2019 Year 03 Month 06 Day

Last modified on

2023 Year 09 Month 08 Day



Link to view the page

Value
https://center6.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