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
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
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
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
