2024-03-29T13:32:58Z
https://tsukuba.repo.nii.ac.jp/oai
oai:tsukuba.repo.nii.ac.jp:00056067
2022-04-27T09:31:12Z
2780:6672
3:62:5592:8131
Augmentation of Positive Valence System–Focused Cognitive Behavioral Therapy by Inaudible High-Frequency Sounds for Anhedonia : A Trial Protocol for a Pilot Study
丸尾, 和司
マルオ, カズシ
MARUO, Kazushi
Ito, Masaya
Miyamae, Mitsuhiro
Yokoyama, Chika
Yamashita, Yuichi
Ueno, Osamu
Komazawa, Asami
Niwa, Madoka
Honda, Manabu
Horikoshi, Masaru
© 2019 ItoM et al.
This is an open access article distributed under the terms of the CC-BY License.
Importance
Recent conceptualizations in Research Domain Criteria have indicated that anhedonia, 1 of 2 core symptoms of depression, which can be treatment resistant, is associated with deficits in the positive valence system, and inaudible high-frequency sound therapy has been shown to enhance reward-related brain circuitry. Hence, cognitive behavioral therapy focusing on the positive valence system enhanced with sound therapy could have a synergistic effect on anhedonia.
Objective
To test the augmentation effect of inaudible high-frequency sounds on the efficacy of positive valence system–focused cognitive behavioral therapy to treat anhedonia.
Design, Setting, and Participants
In this individual-level allocation, exploratory, single-center randomized superiority pilot trial, patients, therapists, and evaluators will be masked to intervention or placebo assignment. The trial will take place at a national psychiatric referral hospital in Tokyo, Japan, among 44 adult patients with clinically significant anhedonia and moderate to severe depression. Outcomes will be analyzed following the intent-to-treat principle using a repeated-measures mixed model.
Intervention
The intervention group will participate in 8 weekly sessions of positive valence system–focused cognitive behavioral therapy with in-session exposure to an inaudible high-frequency sound; the comparison group will undergo cognitive behavioral therapy with in-session exposure to a placebo sound.
Main Outcomes and Measures
The primary outcome is anhedonia assessed using the self-reported Snaith-Hamilton Pleasure Scale. The secondary outcome is anhedonia assessed using the clinician-administered version of the Snaith-Hamilton Pleasure Scale.
Discussion
Recruitment for this study began in May 2018, and the projected date of final allocation is January 2020. A total of 21 eligible patients were registered for participation as of May 30, 2019. To date, treatments for depression do not guarantee clinically successful outcomes. This pilot trial will provide preliminary evidence of the augmentation effect of high-frequency inaudible sounds on cognitive behavioral therapy for anhedonia. Overall, exposure to an inaudible high-frequency sounds does not require attentional or cognitive effort from either patients or therapists; therefore, results from a future confirmative trial could indicate that cognitive behavioral therapy can be augmented in an effortless manner.
American Medical Association
2019-11
eng
journal article
http://hdl.handle.net/2241/00161471
https://tsukuba.repo.nii.ac.jp/records/56067
31747035
10.1001/jamanetworkopen.2019.15819
2574-3805
JAMA Network Open
2
11
e1915819
https://tsukuba.repo.nii.ac.jp/record/56067/files/JAMANO_2-11.pdf
application/pdf
986.3 kB
2020-09-28