UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031617 |
|---|---|
| Receipt number | R000035955 |
| Scientific Title | The effects and predictors of acceptance and commitment therapy for chronic pain : a prospective observational study |
| Date of disclosure of the study information | 2018/03/06 |
| Last modified on | 2020/09/07 09:11:42 |
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Basic information
Public title
The effects and predictors of acceptance and commitment therapy for chronic pain
: a prospective observational study
Acronym
The effects and predictors of acceptance and commitment therapy for chronic pain
: a prospective observational study
Scientific Title
The effects and predictors of acceptance and commitment therapy for chronic pain
: a prospective observational study
Scientific Title:Acronym
The effects and predictors of acceptance and commitment therapy for chronic pain
: a prospective observational study
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Anesthesiology |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness and the predictors of Acceptance and Commitment Therapy for chronic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity and disturbance(Brief Pain Inventory Short Form: BPI), 6 months after the treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)outpatients who consulted pain clinicians.
2)chronic pain over three months.
Key exclusion criteria
1)inadequate for program assessed by psychiatrist.
2)need for hospitalization.
3)receiving other structred psychotherapies.
4)difficult of a routine visit.
5)other reasons inadequate for study participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | SAKAI |
| Middle name | |
| Last name | Mie Sakai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-851-5511
mie.sakai.38@gmail.com
Public contact
Name of contact person
| 1st name | SAKAI |
| Middle name | |
| Last name | Mie Sakai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-851-5511
Homepage URL
mie.sakai.38@gmail.com
Sponsor or person
Institute
Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Thechology
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
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
Tel
0528587215
clinical_research@med.nagoya-cu.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
| 2018 | Year | 03 | Month | 06 | 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
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the effectiveness and the predictors of Acceptance and Commitment Therapy for chronic pain.
Management information
Registered date
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035955
