UMIN-CTR Clinical Trial

Basic information
Public title	Psychological Intervention Program on Insomnia Symptoms
Acronym	Psychological Intervention Program on Insomnia Symptoms
Scientific Title	A Randomized Controlled Trial of Internet-Based Psychosocial Intervention for Safety Behaviors on Insomnia Symptoms
Scientific Title:Acronym	Prevention of Safety Behaviors on Insomnia Symptoms (PSBIS)
Region	Japan

Condition
Condition	Insomnia Symptoms
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effectiveness of interventions for sleep-related safety behaviors in adults without insomnia disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	ISI (Insomnia Severity Index)
Key secondary outcomes	SOL (Sleep Onset Latency) WASO (Wake after sleep onset) NOA (Number of awaking) TST (Total Sleep Time) SE (Sleep Efficiency) PHQ-9 (Patient Health Questionnaire) GAD-7 (Generalized Anxiety Disorder)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	FSET for sleep (False Safety Aid Elimination Therapy for Sleep Treatment)
Interventions/Control_2	PHET (Physical Health Education Treatment)
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Insomnia symptoms (ISI score of 8 and above). 2) Interest in improving their own sleep and willingness to work on tasks and to record their sleep. 3) Subjects with access to a computer to view online websites. 4) Subjects who can understand Japanese explanation and agree with online consent by voluntary free will.
Key exclusion criteria	1) Presence of treatment and hospital visits for sleep disorders or mental illness. 2) Subjects engaged in shift work, including late night. 3) Suicidal ideation (PHQ9 Question 2 of 2 and above).
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shin-ichi Middle name Last name Ishikawa
Organization	Doshisha University
Division name	Faculty of psychology
Zip code	610-0394
Address	1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL	0774-65-7092
Email	ishinn@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Ayaka Middle name Last name Ubara
Organization	Doshisha Unibersity
Division name	Graduate School of Psychology
Zip code	610-0394
Address	1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL	0774-65-8276
Homepage URL
Email	cykc1005@mail2.doshisha.ac.jp

Sponsor
Institute	Doshisha University
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science (JSPS)
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	Doshisha University Faculty of Psychology Research Ethics Committee
Address	1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
Tel	0774-65-7897
Email	ji-sinri@mail.doshisha.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	2021 Year 07 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	58
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	Completed
Date of protocol fixation	2021 Year 06 Month 17 Day
Date of IRB	2021 Year 07 Month 05 Day
Anticipated trial start date	2021 Year 07 Month 07 Day
Last follow-up date	2021 Year 09 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 06 Day
Last modified on	2022 Year 07 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051125