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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032879
Receipt No. R000037465
Scientific Title Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Date of disclosure of the study information 2018/06/17
Last modified on 2018/09/24

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Basic information
Public title Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Acronym Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Scientific Title Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Scientific Title:Acronym Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Region
Japan

Condition
Condition Type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effect of ultra-brief cognitive and behavior therapy on Glucose fluctuations and self-management in Japanese out-patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glucose fluctuations data (FreeStyle Libre Pro)
Key secondary outcomes Self-care behavior in daily life (Ecological momentary assessment)
Acceptance and Action Diabetes Questionnaire (AADQ)
Mindfulness Attention Awareness Scale (MAAS)
Values Clarification Questionnaire (VCQ)
Patient Health Questionnaire-9 (PHQ-9)
Body mass index (BMI)
HbA1c

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Ultra-brief cognitive and behavior therapy: 1 session (90min to 120min)
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Japanese out-patients are included if they were between 20 and 79 years-of-age and have been receiving medical care under diagnosis of type 2 diabetes mellitus according to the classifications by the Japan Diabetes Society and World Health Organization.
Key exclusion criteria 1) cannot understand Japanese well.
2) type1 diabetes and the secondary forms of diabetes.
3) affected with severe diabetes complication; diabetic retinopathy with impaired vision, impaired renal function (eGFR <30 and macroproteinuria), painful neuropathy.
4) affected with severe cardiovascular diseases and decline in ability of daily life.
5) affected with severe mental illness.
6) Cognitive dysfunction; Altzheimer type dementia, vascular dementia, and so on.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki KUMANO
Organization Waseda University
Division name Faculty of Human Science
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL +81-4-2949-8113
Email hikumano@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi SAITO
Organization Waseda University
Division name Graduate School of Human Science
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL +81-4-2949-8113
Homepage URL
Email tekuteke@toki.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Grant-in-Aid for JSPS Research Fellow
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2017-298
Org. issuing International ID_1 Waseda University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 17 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 17 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
2018 Year 06 Month 05 Day
Last modified on
2018 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037465

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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