UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054357 |
|---|---|
| Receipt number | R000062089 |
| Scientific Title | Evaluation of the usefulness of pharmacist-led cognitive behavioral therapy for insomnia |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/05/09 21:38:10 |
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Basic information
Public title
Evaluation of the usefulness of pharmacist-led cognitive behavioral therapy for insomnia in patients with residual insomnia after depression remission
Acronym
Evaluation of the usefulness of pharmacist-led cognitive behavioral therapy for insomnia
Scientific Title
Evaluation of the usefulness of pharmacist-led cognitive behavioral therapy for insomnia
Scientific Title:Acronym
Evaluation of the usefulness of pharmacist-led cognitive behavioral therapy for insomnia in patients with residual insomnia after depression remission
Region
| Japan |
Condition
Condition
Residual insomnia after remission of depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of cognitive behavioral therapy for insomnia administered by pharmacists in patients with residual insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare changes in the DBAS-16 before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CBT-I
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose depression is in remission and who are taking one or more hypnotic.
Key exclusion criteria
Patients whose depression is not in remission and who are not taking hypnotic at all.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hashimoto |
| Middle name | |
| Last name | Yasuhiko |
Organization
Kobe Gakuin University
Division name
Faculty of Clinical Pharmacy
Zip code
650-8586
Address
1-1-3, minatojima, chuo-ku, Kobe
TEL
0789744907
yhashi@pharm.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Hashimoto |
| Middle name | |
| Last name | Yasuhiko |
Organization
Kobe Gakuin University
Division name
Faculty of Clinical Pharmacy
Zip code
650-8586
Address
1-1-3, minatojima, chuo-ku, Kobe
TEL
0789741551
Homepage URL
yhashi@pharm.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin University
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
Kobe Gakuin University
Address
1-1-3 Minatojima, Chuo-ki, Kobe
Tel
078-974-1551
kenkyu@j.kobegakuin.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 | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062089
