TY - JOUR
T1 - Neural and clinical changes of cognitive behavioural therapy versus talking control in patients with major depression
T2 - A study protocol for a randomised clinical trial
AU - Katayama, Nariko
AU - Nakagawa, Atsuo
AU - Abe, Takayuki
AU - Kurata, Chika
AU - Sasaki, Yohei
AU - Mitsuda, Dai
AU - Nakao, Shigetsugu
AU - Mizuno, Sayuri
AU - Ozawa, Mire
AU - Nakagawa, Yuko
AU - Ishikawa, Natsumi
AU - Umeda, Satoshi
AU - Terasawa, Yuri
AU - Tabuchi, Hajime
AU - Kikuchi, Toshiaki
AU - Mimura, Masaru
N1 - Funding Information:
Competing interests AN developed and wrote the Japanese CBT manual for depression and is involved in the National CBT Training and Supervision Project funded by the Japanese Ministry of Health Labour and Welfare.
Funding Information:
Funding This research is supported by the Commissioned Research of National Institute of Information and Communications Technology grant: Research and development of technology for enhancing functional recovery of elderly and disabled people based on non-invasive brain imaging and robotic assistive devices. It is also supported by the Japan Society for the Promotion of Science KAKENHI grants (numbers 24120518, 24330210, 26780396 and JP17K04452), Inokashira Hospital Grants for Psychiatry Research and the Keio University School of Medicine Department of Neuropsychiatry Young Investigator Research Grant.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/2/25
Y1 - 2020/2/25
N2 - While major depression causes substantial distress and impairment for affected individuals and society, the effectiveness of cognitive behavioural therapy (CBT) in treating the condition has been established. However, the therapeutic mechanism underlying the efficacy of CBT remains unknown. This study aimed to describe a protocol for a randomised controlled trial that will measure the CBT-induced clinical and neural changes in patients with non-psychotic major depression. Methods and analysis The current study is a 16-week assessor-blinded, randomised, parallel-group trial with a 12-month follow-up as part of usual depression care at an outpatient clinic. Patients aged 20-69 years with major depressive disorder will be randomly assigned to receive either CBT in addition to their usual treatment or talking control in addition to their usual treatment for 16 weeks. The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life. The intention-to-treat analysis will be used. Ethics and dissemination All protocols and the informed consent form are compliant with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethical Review Committees at the Keio University School of Medicine have approved the study protocol (version 3, 11 September 2017). We will disseminate research findings to scientific and general audiences through national and international conference presentations as well as lay summaries to the general public, including mental health consumer and publications in international peer-reviewed psychiatry and brain imaging journals. Trial registration number UMIN Clinical Trials Registry (UMIN000018155); Pre-results.
AB - While major depression causes substantial distress and impairment for affected individuals and society, the effectiveness of cognitive behavioural therapy (CBT) in treating the condition has been established. However, the therapeutic mechanism underlying the efficacy of CBT remains unknown. This study aimed to describe a protocol for a randomised controlled trial that will measure the CBT-induced clinical and neural changes in patients with non-psychotic major depression. Methods and analysis The current study is a 16-week assessor-blinded, randomised, parallel-group trial with a 12-month follow-up as part of usual depression care at an outpatient clinic. Patients aged 20-69 years with major depressive disorder will be randomly assigned to receive either CBT in addition to their usual treatment or talking control in addition to their usual treatment for 16 weeks. The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life. The intention-to-treat analysis will be used. Ethics and dissemination All protocols and the informed consent form are compliant with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethical Review Committees at the Keio University School of Medicine have approved the study protocol (version 3, 11 September 2017). We will disseminate research findings to scientific and general audiences through national and international conference presentations as well as lay summaries to the general public, including mental health consumer and publications in international peer-reviewed psychiatry and brain imaging journals. Trial registration number UMIN Clinical Trials Registry (UMIN000018155); Pre-results.
KW - clinical protocols
KW - cognitive behaviour therapy
KW - functional MRI
KW - major depressive disorder
KW - randomised controlled trial
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U2 - 10.1136/bmjopen-2019-029735
DO - 10.1136/bmjopen-2019-029735
M3 - Article
C2 - 32102803
AN - SCOPUS:85080118391
SN - 2044-6055
VL - 10
JO - BMJ open
JF - BMJ open
IS - 2
M1 - e029735
ER -
