UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046018 |
|---|---|
| Receipt number | R000052526 |
| Scientific Title | Randomized controlled trials examining the effectiveness of internet cognitive-behavioral therapy for workers with chronic tension-type headache |
| Date of disclosure of the study information | 2021/11/10 |
| Last modified on | 2023/02/28 15:42:03 |
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Basic information
Public title
Randomized controlled trials examining the effectiveness of internet cognitive-behavioral therapy for workers with chronic tension-type headache
Acronym
Randomized controlled trials examining the effectiveness of internet cognitive-behavioral therapy for workers with chronic tension-type headache
Scientific Title
Randomized controlled trials examining the effectiveness of internet cognitive-behavioral therapy for workers with chronic tension-type headache
Scientific Title:Acronym
Randomized controlled trials examining the effectiveness of internet cognitive-behavioral therapy for workers with chronic tension-type headache
Region
| Japan |
Condition
Condition
Chronic tension-type headache
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of self-help interventions without email support as non-invasive self-medication for adults with chronic tension-type headache but not receiving medication. As self-help interventions, (1) study treatment group (Internet cognitive behavioral therapy) and (2) control group (psychoeducation) will be set and randomized controlled trials will be conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
BPI; brief pain inventory
Key secondary outcomes
PCS; pain catastrophizing scale
ISI; Insomnia Severity Index
HIT-6; headache impact test
GAD-7; Generalized Anxiety Disorder
PHQ-9; Patient Health Questionnaire
EQ-5D-5L; EuroQOL - 5 dimensions - 5 level
WHO-HPQ; WHO Health and Work Performance
Questionnaire
Headache frequency / week
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 |
Interventions/Control_1
Internet-based Cognitive Behavioral Therapy program
Interventions/Control_2
Health education
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Headache symptoms (HIT score 50 points or more)
Meet the diagnosis of chronic tension-type headache
Headache lasts for at least 3 months
No abnormalities including follow-up have been pointed out in the latest health examination
Have an internet environment
Understand the explanation in Japanese and obtain online consent at your own free will
Key exclusion criteria
Moderate or higher anxiety symptoms (GAD-7 score 10 points or higher)
Moderate or higher depressive symptoms (PHQ-9 score 10 points or higher)
Alcohol dependence
Drug addiction
Suicidal ideation (PHQ-9 Q9 score is 2 points or more)
Have been diagnosed with serious, progressive physical illnesses such as cancer and heart failure
Have been diagnosed with psychiatric disorders such as schizophrenia, mood disorders and alcohol dependence
Currently undergoing outpatient treatment for some illness including headache
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Graduate School of Medicine
Research Center for Child Mental Development
Cognitive Behavioral Center of Chiba University Hospital
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Nakamura |
| Middle name | |
| Last name | Hideki |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL
043-226-2027
Homepage URL
cafa4942@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Economy, Trade and Industry
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
Chiba university hospital clinical research center
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, Japan
Tel
043-222-7171
chibacrc@mac.com
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052526
