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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023206
Receipt No. R000026752
Scientific Title Enhancement of Cognitive Behavioral therapy for anxiety disorders and posttraumatic stress disorder by bright light exposure
Date of disclosure of the study information 2016/07/17
Last modified on 2017/12/21

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Basic information
Public title Enhancement of Cognitive Behavioral therapy for anxiety disorders and posttraumatic stress disorder by bright light exposure
Acronym Enhancement of CBT for anxiety disorders and PTSD by bright light
Scientific Title Enhancement of Cognitive Behavioral therapy for anxiety disorders and posttraumatic stress disorder by bright light exposure
Scientific Title:Acronym Enhancement of CBT for anxiety disorders and PTSD by bright light
Region
Japan

Condition
Condition anxiety disorders and PTSD
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of bright light exposure during exposure-based CBT for anxiety disorders and PTSD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes State Trait Anxiety Inventory (STAI)
Key secondary outcomes 36-item short form of the MOS Questionnaire: SF-36
WHO Disability Schedule 2.0 (WHODAS 2.0)
Montgomery-Asberg Depression Rating Scale (MADRS-S)
Pittsburgh Sleep Quality Index (PSQI)
Columbia-Suicide Severity Rating Scale: C-SSRS
Alcohol Use Disorder Identification Test: AUDIT
functional neuroimaging (fMRI)
Liebowitz Social Anxiety Scale: LSAS-SR
Panic Disorder Severity Scale: PDSS-SR
Mobility Inventory for Agoraphobia: MIA
Severity Measure for Specific Phobia-Adult: SMSP-A
Impact of Event Scale Revised: IES-R

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention: Bright-light ME (8,000 lx); 30-45 min/week; Total 8 times (2 months).
Interventions/Control_2 Sham: TWINBIRD LK-H345 (sham: 800 lx); 30-45 min/week: Total 8 times (2 months).
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

Not applicable
Gender Male and Female
Key inclusion criteria Meet a clinical criterion for anxiety disorders (Panic disorder, Social anxiety disorder, Agoraphobia, Specific phobia) or PTSD in DSM-5.
Anxiety severity (STAI-S: Higher than 40).
Key exclusion criteria 1) Comorbid psychiatric disorders met in DSM-5 criteria.
2) Physical disorder diagnoses associated with the anxiety disorders or PTSD.
3) Severe suicidal ideation (C-SSRS: not less than 3).
4) Severe depressive symptoms (MADRS-S: 30 and over).
5) Pregnancy.
6) Retinal diseases.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Kuriyama
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code
Address Seta, Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2291
Email kenichik@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Kuriyama
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code
Address Seta, Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2291
Homepage URL
Email kenichik@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 17 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
2016 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 17 Day
Last modified on
2017 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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