UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009554 |
|---|---|
| Receipt number | R000011116 |
| Scientific Title | Evaluation of the efficacy of the autogenic training for the treatment of stress related diseases |
| Date of disclosure of the study information | 2012/12/14 |
| Last modified on | 2012/12/14 17:32:27 |
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Basic information
Public title
Evaluation of the efficacy of the autogenic training for the treatment of stress related diseases
Acronym
Autogenic training for the stress related diseases
Scientific Title
Evaluation of the efficacy of the autogenic training for the treatment of stress related diseases
Scientific Title:Acronym
Autogenic training for the stress related diseases
Region
| Japan |
Condition
Condition
Stress related diseases
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy, safety, and economical effect of the autogenic training for the treatment of stress related diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of autogenic training performed to the patients of stress related diseases on physical symptoms, psychological symptoms, medical cost, usage of drugs, quality of life, and stress coping behaviors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Addition of autogenic training to the standard treatment
Interventions/Control_2
Standard treatment
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of stress related disease who can answer the self-administered questionnaires and can perform autogenic training by themselves
Key exclusion criteria
Who is found a new organic disease, or admits a hospital, or move out from the area within the study period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kanemitsu |
Organization
Fukuoka Dental College
Division name
Section of Psychosomatic Medicine
Zip code
Address
2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL
092-801-0411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshisuke Miki |
Organization
Fukuoka Dental College
Division name
Department of Genaral Affairs
Zip code
Address
2-15-1 Tamura, Sawara-ku, Fukuoka 814-0193, Japan
TEL
092-801-0411
Homepage URL
shomu@college.fdc-net.ac.jp
Sponsor or person
Institute
Section of Psychosomatic Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Psychosomatic Medicine, Kyusyu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡歯科大学医科歯科総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 14 | 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
| 2012 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 14 | Day |
Last modified on
| 2012 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011116
