UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024461 |
|---|---|
| Receipt number | 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 | 2023/10/02 18:08:21 |
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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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive behavioral therapy for sleep problems with ADHD/ASD
Interventions/Control_2
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.
4. ISI>=8
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
12
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
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
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028131
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028131
Number of participants that the trial has enrolled
10
Results
The results showed that the intervention significantly improved sleep disturbances at post-intervention (p=0.003, d=1.30, 95%CI 0.31-2.28) and at the 3-month follow-up (p=0.035, d=0.41, 95%CI -0.48 to 1.30). In addition, attention switching for ASD symptoms was significantly reduced post-intervention (p=0.031, d=1.16, 95% CI 0.19-2.13).
Results date posted
| 2023 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten patients with adult ADHD and/or ASD with sleep disturbances (10 males, age: 27.4+/-5.6 years)
Participant flow
A total of 12 adult ADHD and/or ASD outpatients with sleep complaints participated in this study. Two of them were dropped out of the study. All participants were assessed for all self-administered scales before and after the intervention, and at 3-month follow-up.
Adverse events
None
Outcome measures
Insomnia severity index (ISI)
Hospital anxiety and depression scale (HADS)
Autism-Spectrum quotient (AQ)
ADHD self-report scale (ASRS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028131
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| Registered date | File name |
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