UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048019 |
|---|---|
| Receipt number | 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 | 2023/06/13 00:16:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
katou_takao@kurume-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kurume University School of Medicine
Institute
Department
Personal name
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
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
| 2024 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 15 | Day |
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
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054731
