UMIN-CTR Clinical Trial

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 Kenichi Middle name Last name Kuriyama
Organization	Shiga University of Medical Science
Division name	Department of Psychiatry
Zip code	520-2192
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 Kenichi Middle name Last name Kuriyama
Organization	Shiga University of Medical Science
Division name	Department of Psychiatry
Zip code	520-2192
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	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethical Review Board of Shiga University of Medical Science
Address	Seta Tsukinowa-cho, Otsu, Shiga
Tel	077-548-3579
Email	hqkenkyu@belle.shiga-med.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	滋賀医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s41105-019-00248-7
Number of participants that the trial has enrolled	14
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	Main results already published
Date of protocol fixation	2016 Year 06 Month 22 Day
Date of IRB	2016 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 17 Day
Last modified on	2020 Year 01 Month 20 Day

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