A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol

Abstract Background Attention‐deficit/hyperactivity disorder (ADHD) symptoms, including executive function, emotional regulation, and motivation, can persist into adulthood and are often associated with mental illnesses. Cognitive behavioral therapy (CBT) may help ADHD adults in Japan, but the lack...

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Main Authors: Naoki Takamatsu, Misuzu Nakashima, Kei Matsuura, Ikue Umemoto, Masaya Ito, Junichiro Kanazawa, Hirofumi Tomiyama, Masaki Kondo, Hisateru Tachimori, Tomohiro Nakao, Masaru Horikoshi, Hironori Kuga
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Language:English
Published: Wiley 2024-12-01
Series:PCN Reports
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Online Access:https://doi.org/10.1002/pcn5.70036
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author Naoki Takamatsu
Misuzu Nakashima
Kei Matsuura
Ikue Umemoto
Masaya Ito
Junichiro Kanazawa
Hirofumi Tomiyama
Masaki Kondo
Hisateru Tachimori
Tomohiro Nakao
Masaru Horikoshi
Hironori Kuga
author_facet Naoki Takamatsu
Misuzu Nakashima
Kei Matsuura
Ikue Umemoto
Masaya Ito
Junichiro Kanazawa
Hirofumi Tomiyama
Masaki Kondo
Hisateru Tachimori
Tomohiro Nakao
Masaru Horikoshi
Hironori Kuga
author_sort Naoki Takamatsu
collection DOAJ
description Abstract Background Attention‐deficit/hyperactivity disorder (ADHD) symptoms, including executive function, emotional regulation, and motivation, can persist into adulthood and are often associated with mental illnesses. Cognitive behavioral therapy (CBT) may help ADHD adults in Japan, but the lack of studies and the variability in group CBT approaches make its effects unclear. Japan lacks unified CBT programs and adult ADHD guidelines, making it difficult to implement international individual CBT recommendations due to cultural differences. This study will assess the feasibility of a novel CBT program for Japanese adult ADHD patients. Methods This feasibility study will be open, nonrandomized, single‐arm, multicenter study. Twelve ADHD patients aged 20–65 years who are currently receiving treatment will be included based on Conners' Adult ADHD Rating Scale (CAARS) clinical severity threshold. An intervention phase of 12–16 weeks and a 12‐week follow‐up will total 24–28 weeks for all participants. The intervention will use a new CBT program tailored to individual assessments. Results The primary objective is to determine feasibility using dropout rates, adverse events, and CAARS score changes between Weeks 1 and 16. The secondary outcomes will assess long‐term effects of treatment beyond the intervention period and provide descriptive statistics on sex, depression, quality of life, and autistic scores in relation to the intervention outcomes. The full analysis set and per protocol set will be used for statistical analysis. Conclusions This study is essential for the development of CBT interventions in accordance with Japan's healthcare system that are tailored to the unique needs of its population.
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spelling doaj-art-3ed8daf2f10047bcb16ddb9dfeadd95d2025-01-03T11:15:26ZengWileyPCN Reports2769-25582024-12-0134n/an/a10.1002/pcn5.70036A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocolNaoki Takamatsu0Misuzu Nakashima1Kei Matsuura2Ikue Umemoto3Masaya Ito4Junichiro Kanazawa5Hirofumi Tomiyama6Masaki Kondo7Hisateru Tachimori8Tomohiro Nakao9Masaru Horikoshi10Hironori Kuga11National Center of Neurology and Psychiatry Tokyo JapanNational Hospital Organization Hizen Psychiatric Center Yoshinogari JapanNational Center of Neurology and Psychiatry Tokyo JapanNational Center of Neurology and Psychiatry Tokyo JapanNational Center of Neurology and Psychiatry Tokyo JapanHealth Sciences, University of Hokkaido Ishikari‐gun JapanDepartment of Neuropsychiatry Graduate School of Medical Sciences, Kyushu University Fukuoka JapanNational Center of Neurology and Psychiatry Tokyo JapanNational Center of Neurology and Psychiatry Tokyo JapanDepartment of Neuropsychiatry Graduate School of Medical Sciences, Kyushu University Fukuoka JapanNational Center of Neurology and Psychiatry Tokyo JapanNational Center of Neurology and Psychiatry Tokyo JapanAbstract Background Attention‐deficit/hyperactivity disorder (ADHD) symptoms, including executive function, emotional regulation, and motivation, can persist into adulthood and are often associated with mental illnesses. Cognitive behavioral therapy (CBT) may help ADHD adults in Japan, but the lack of studies and the variability in group CBT approaches make its effects unclear. Japan lacks unified CBT programs and adult ADHD guidelines, making it difficult to implement international individual CBT recommendations due to cultural differences. This study will assess the feasibility of a novel CBT program for Japanese adult ADHD patients. Methods This feasibility study will be open, nonrandomized, single‐arm, multicenter study. Twelve ADHD patients aged 20–65 years who are currently receiving treatment will be included based on Conners' Adult ADHD Rating Scale (CAARS) clinical severity threshold. An intervention phase of 12–16 weeks and a 12‐week follow‐up will total 24–28 weeks for all participants. The intervention will use a new CBT program tailored to individual assessments. Results The primary objective is to determine feasibility using dropout rates, adverse events, and CAARS score changes between Weeks 1 and 16. The secondary outcomes will assess long‐term effects of treatment beyond the intervention period and provide descriptive statistics on sex, depression, quality of life, and autistic scores in relation to the intervention outcomes. The full analysis set and per protocol set will be used for statistical analysis. Conclusions This study is essential for the development of CBT interventions in accordance with Japan's healthcare system that are tailored to the unique needs of its population.https://doi.org/10.1002/pcn5.70036ADHD in adulthoodattention‐deficit/hyperactivity disordercognitive behavioral therapyfeasibility studyindividual CBT
spellingShingle Naoki Takamatsu
Misuzu Nakashima
Kei Matsuura
Ikue Umemoto
Masaya Ito
Junichiro Kanazawa
Hirofumi Tomiyama
Masaki Kondo
Hisateru Tachimori
Tomohiro Nakao
Masaru Horikoshi
Hironori Kuga
A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
PCN Reports
ADHD in adulthood
attention‐deficit/hyperactivity disorder
cognitive behavioral therapy
feasibility study
individual CBT
title A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
title_full A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
title_fullStr A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
title_full_unstemmed A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
title_short A multicenter, single‐group, open feasibility study of a new individual cognitive behavioral therapy program for adult Japanese patients with attention‐deficit/hyperactivity disorder: Study protocol
title_sort multicenter single group open feasibility study of a new individual cognitive behavioral therapy program for adult japanese patients with attention deficit hyperactivity disorder study protocol
topic ADHD in adulthood
attention‐deficit/hyperactivity disorder
cognitive behavioral therapy
feasibility study
individual CBT
url https://doi.org/10.1002/pcn5.70036
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