UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of CBT-I with videos for sleep disturbances with insomnia in adult ADHD patients.
Acronym	Efficacy of CBT-I with videos for sleep disturbances with insomnia in adult ADHD patients.
Scientific Title	Efficacy of CBT-I with videos for sleep disturbances with insomnia in adult ADHD patients.
Scientific Title:Acronym	Efficacy of CBT-I with videos for sleep disturbances with insomnia in adult ADHD patients.
Region	Japan

Condition
Condition	Attention Deficit Hyperactivity Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the effectiveness of CBT-i in adult ADHD patients diagnosed with insomnia at our outpatient sleep clinic by subjectively and objectively assessing the improvement in severity of insomnia and psychiatric symptoms of ADHD at each session. In addition, we will explore methods of cognitive-behavioral therapy that can be used more easily in clinical practice.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Athens Insomnia Scale,Pittsburgh Sleep Quality Index,Ford Insomnia Response to Stress Test,Dysfunctional Beliefs and attuitudes about Sleep Scale
Key secondary outcomes	MEQ SA, Epwroth Sleepness Score, Philips Actiwatch Activity monitor, Adult ADHD Self Report Scale, ADHD RS with adult prompts, SF8 Health Survey, Beck Depression Inventory Second Edition, Psychomotor Vigilance Task Monitor

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Groups with cognitive behavioral therapy in the treatment of insomnia Cognitive Behavior Therapy for Insomnia" is a video (each about 25 minutes long) created by the principal investigator based on the Cognitive Behavior Therapy for Insomnia workshop of the Japan Sleep Society, which consists of a "sleep hygiene instruction part, sleep schedule method (sleep restriction method and stimulus control method) part, and relaxation method part. The "Sleep Hygiene Instruction Part, Sleep Scheduling Method (Sleep Restriction and Stimulus Control Method) Part, and Relaxation Method Part" videos (each approximately 25 minutes in length) prepared by the principal investigator based on the Cognitive Behavioral Therapy for Insomnia training course of the Japan Sleep Society are shown to patients at least three times via tablet or home PC at their next outpatient visit. The intervention period is from 3 to 6 months.
Interventions/Control_2	No cognitive-behavioral therapy in the treatment of insomnia
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 who are at least 18 years of age and have given written consent to participate in the study. Patients who meet the diagnostic criteria for ADHD in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Patients who score at least 7 points on the Japanese version of the Insomnia Severity Questionnaire (ISI-J) and meet the diagnostic criteria for insomnia disorders of the International Classification of Sleep Disorders 3rd edition (ICSD-3). Those who agree to wear the ActiWatch during the study period.
Key exclusion criteria	Persons with serious mental or physical illnesses such as depression or schizophrenia that are likely to affect the performance of this study. Those who are judged to be inappropriate as research subjects by the principal investigator and research coordinators. Those with sleep disorders such as central hypersomnia, sleep apnea syndrome (SAS), periodic limb movement disorder (PLMD), restless legs syndrome (RLS), etc. as determined by PSG and repeated sleep latency test (MSLT).
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Kato
Organization	Kurume University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	8300011
Address	67 Asahimachi, kurume-shi, Fukuoka
TEL	0942-31-7564
Email	katou_takao@kurume-u.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Kato
Organization	Kurume University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	8300011
Address	67 Asahimachi, kurume-shi, Fukuoka
TEL	0942-31-7564
Homepage URL
Email	katou_takao@kurume-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Department of Neuropsychiatry, Kurume University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Neuropsychiatry, Kurume University School of Medicine
Address	67 Asahimachi, kurume-shi, Fukuoka
Tel	0942-31-7564
Email	katou_takao@kurume-u.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	2022 Year 08 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 15 Day
Date of IRB	2022 Year 01 Month 07 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2023 Year 10 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 10 Day
Last modified on	2022 Year 06 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054731

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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