UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054815 |
|---|---|
| Receipt number | R000062572 |
| Scientific Title | An investigation of changes in time perception influenced by cognitive behavioral therapy for depression |
| Date of disclosure of the study information | 2024/06/28 |
| Last modified on | 2024/06/28 21:51:54 |
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Basic information
Public title
An investigation of changes in time perception influenced by cognitive behavioral therapy for depression
Acronym
CBT for depression and time perception changes
Scientific Title
An investigation of changes in time perception influenced by cognitive behavioral therapy for depression
Scientific Title:Acronym
CBT for depression and time perception changes
Region
| Japan |
Condition
Condition
Patients with depressive symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the changes in time perception in both patients and therapists caused by cognitive behavioral therapy for depression
Basic objectives2
Others
Basic objectives -Others
To unveil the underlying mechanism of cognitive behavioral therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in produced time interval of both patient and therapist before and after treatment sessions
Key secondary outcomes
1) Both patient and therapist
Changes in: subjective mood and sleepiness before and after treatment sessions; skin conductance response, body temperature, pulse rate, and physical activity during treatment sessions; and subjective evaluation of treatment after treatment sessions
2) Patients
Changes in: Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Clinical Global Impression (CGI), and Patient Global Impression of Change (PGIC)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Criteria for patients
1) Aged 18 years or older
2) Capable to provide informed consent
3) Patients who are attending or able to attend our outpatient clinic
4) A score >= 6 on the QIDS-SR
Criteria for therapists
1) A certified clinical or public psychologist who conducts cognitive behavioral therapy at our outpatient clinic
2) Capable to provide informed consent
Key exclusion criteria
Criteria for patients
1) Patients with substance-related disorders within 6 months
2) Patients undergoing electroconvulsive therapy or repetitive transcranial magnetic stimulation
3) Patients with severe physical or neurological diseases
4) Patients for whom the study procedures hinder receiving cognitive behavioral therapy
Criteria for therapists
1) Therapists for whom the study procedures hinder conducting cognitive behavioral therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshiike |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL
042-346-2014
yoshiike@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshiike |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL
042-346-2014
Homepage URL
yoshiike@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
Ethical Committee of National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo
Tel
042-341-2712
ml_rinri-jimu@ncnp.go.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 | 06 | Month | 28 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062572
