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UMIN-CTR Clinical Trial |
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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 |
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. | |
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Condition | ||
Condition | Attention Deficit Hyperactivity Disorder | |
Classification by specialty |
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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 |
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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. |
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Interventions/Control_2 | No cognitive-behavioral therapy in the treatment of insomnia | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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). |
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Target sample size | 36 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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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 | |
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Research case data | |
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