UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053933 |
|---|---|
| Receipt number | R000061559 |
| Scientific Title | Effects of Psychotherapy on Pain Catastrophic Thinking and Life Disability in Psychosomatic Patients with Chronic Headache |
| Date of disclosure of the study information | 2024/03/21 |
| Last modified on | 2024/03/21 16:13:02 |
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Basic information
Public title
Effects of Psychotherapy on Pain Catastrophic Thinking and Life Disability in Psychosomatic Patients with Chronic Headache
Acronym
Effects of Psychotherapy on Pain Catastrophic Thinking and Life Disability in Psychosomatic Patients with Chronic Headache
Scientific Title
Effects of Psychotherapy on Pain Catastrophic Thinking and Life Disability in Psychosomatic Patients with Chronic Headache
Scientific Title:Acronym
Effects of Psychotherapy on Pain Catastrophic Thinking and Life Disability in Psychosomatic Patients with Chronic Headache
Region
| Japan |
Condition
Condition
Chronic headache
Classification by specialty
| Neurology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of the effects of psychotherapy on catastrophic thoughts and life obstacles in patients with chronic headache with psychosomatic aspects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The HIT-6 for headache life obstacles will be measured once before and once at the end of the program (6 weeks later), respectively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
For the psychotherapy group, a program of 45 minutes per session is conducted six times. We recommend that patients come to the office once a week. Questionnaires will be administered before and after the psychotherapy and the results will be compared to determine the effectiveness of the psychotherapy.
Interventions/Control_2
The usual care group will receive the questionnaire twice, approximately one and a half to two months apart.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Persons 18 years of age or older
b.Those who have been diagnosed with chronic headache (psychosomatic)
Key exclusion criteria
a. Persons under the age of 18
b. Persons with severe psychiatric symptoms, such as preoccupation with death
c. Persons with a history of dementia, alcoholism, or drug addiction
d. Those who are in a psychiatric hospital for other mental illnesses.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hashizume |
Organization
Toho University School of Medicine
Division name
Department of Psychosomatic Medicine
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo-to 143-8541 Japan
TEL
03-3762-4151
kaho.tanobe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaho |
| Middle name | |
| Last name | Tanobe |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama, 35 9-1192 JAPAN
TEL
04-2947-6848
Homepage URL
kaho199566317@ruri.waseda.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University Medical Center Omori Hospital
Address
6-11-1 Omorinishi, Ota-ku, Tokyo-to 143-8541 Japan
Tel
03-5763-6534
omori.rinri@ext.toho-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 21 | 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
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061559
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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