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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000024461
Receipt No. R000028131
Scientific Title The impact of cognitive behavioral therapy for sleep problem on symptoms and sleep in adult ADHD/ASD.
Date of disclosure of the study information 2016/10/19
Last modified on 2019/04/22

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Basic information
Public title The impact of cognitive behavioral therapy for sleep problem on symptoms and sleep in adult ADHD/ASD.
Acronym CBT for sleep problem in adult ADHD/ASD
Scientific Title The impact of cognitive behavioral therapy for sleep problem on symptoms and sleep in adult ADHD/ASD.
Scientific Title:Acronym CBT for sleep problem in adult ADHD/ASD
Region
Japan

Condition
Condition adult attention-deficit/hyperactivity disorder; adult autism spectrum disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study is to develop Cognitive Behavioral Therapy for sleep problem with adult ADHD/ASD and to examine about the efficacy of the treatment on the reduction of sleep problems and disorder-specific symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Insomnia Severity Index (ISI); At pre- and post-treatment, and 3-month follow-up
Key secondary outcomes Sleep diary; during the treatment (5-week)
Hospital Anxiety Depression Scale (HADS);At pre- and post-treatment, and 3-month follow-up
ADHD self-rating Scale (ASRS);At pre- and post-treatment, and 3-month follow-up
Autism-spectrum Quotient (AQ);At pre- and post-treatment, and 3-month follow-up
Sheehan Disability Scale (SDISS); At pre- and post-treatment, and 3-month follow-up

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive behavioral therapy for sleep problems with ADHD/ASD
Interventions/Control_2 Wait-list control
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients met the criteria for ADHD and/or ASD on DSM-5 (APA, 2013).
2. The patients suffering from initial, middle, terminal sleep difficulties, and/or daytime sleepiness
3. the patients who is determined to allow participation in the trial by the judgment of the doctor.
Key exclusion criteria 1. The patients who is difficult to participate continuously in the trial.
2. The patients met the criteria for sleep apnea, narcolepsy, idiopathic hypersomnia, restless legs syndrome, and periodic limb movement disorder (ICSD-3, 2014).
Target sample size 36

Research contact person
Name of lead principal investigator
1st name ISA
Middle name
Last name OKAJIMA
Organization Tokyo Kasei University
Division name Faculty of Humanities
Zip code 173-8602
Address 1-18-1 Kaga, Itabashi-ku, 173-8602 Tokyo, Japan
TEL 03-3961-5276
Email okajima-i@tokyo-kasei.ac.jp

Public contact
Name of contact person
1st name ISA
Middle name
Last name OKAJIMA
Organization Tokyo Kasei University
Division name Faculty of Humanities
Zip code 173-8602
Address 1-18-1 Kaga, Itabashi-ku, 173-8602 Tokyo, Japan
TEL 03-3961-5276
Homepage URL
Email okajima-i@tokyo-kasei.ac.jp

Sponsor
Institute Tokyo Kasei University
Institute
Department

Funding Source
Organization Tokyo Kasei University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Kasei University
Address 1-18-1 Kaga, Itabashi-ku, Tokyo
Tel 03-3961-5276
Email okajima-i@tokyo-kasei.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 公益財団法人神経研究所

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 19 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 Suspended
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 10 Month 20 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028131

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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