UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019653 |
|---|---|
| Receipt number | R000022711 |
| Scientific Title | Computer-assisted Mindfulness-based Cognitive Therapy: feasibility study |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2020/11/08 18:40:44 |
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Basic information
Public title
Computer-assisted Mindfulness-based Cognitive Therapy: feasibility study
Acronym
IT-MBCT: feasibility study
Scientific Title
Computer-assisted Mindfulness-based Cognitive Therapy: feasibility study
Scientific Title:Acronym
IT-MBCT: feasibility study
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility of computer-assisted Mindfulness-based Cognitive Therapy for psychological distress of cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospital Anxiety and Depression Scale (HADS)(before intervention, post-intervention and 4 weeks after termination)
Key secondary outcomes
Edmonton Symptom Assessment Scale (ESAS)
Athens Insomnia Scale(AIS)
Interview on the experience of the program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Computer-assisted Mindfulness-based Cognitive Therapy: 30mins, four to eight session, weekly or fortnightly
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
Cancer patients who are treated at Keio University Hospital (Department of Neuropsychiatry, Palliative Care Center, or Surgical Department), are able to attend three or more sessions, and have submitted written consent.
Key exclusion criteria
Patients who simultaneously receive other MBCT programs, have severe physical or psychiatric symptoms that may interfere with program attendance, or were denied permission to participate in the program by their physician in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujisawa |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
dai_fujisawa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujisawa |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
dai_fujisawa@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Hospice Palliative Care Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku-ku
Tel
03-3353-1211
dfujisawa@keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | 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
6
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022711
