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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048019
Receipt No. R000054731
Scientific Title Efficacy of CBT-I with videos for sleep disturbances with insomnia in adult ADHD patients.
Date of disclosure of the study information 2022/08/01
Last modified on 2022/06/10

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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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