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Title: Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): Study protocol for a randomized controlled trial
Authors: Watanabe, Norio
Horikoshi, Masaru
Yamada, Mitsuhiko
Shimodera, Shinji
Akechi, Tatsuo
Miki, Kazuhira
Inagaki, Masatoshi
Yonemoto, Naohiro
Imai, Hissei
Tajika, Aran  kyouindb  KAKEN_id
Ogawa, Yusuke  kyouindb  KAKEN_id
Takeshima, Nozomi
Hayasaka, Yu
Furukawa, Toshi A.
Author's alias: 小川, 雄右
古川, 壽亮
Keywords: Behavior therapy
Cognitive therapy
Computer-assisted therapy
Randomized controlled trials
Issue Date: 7-Jul-2015
Publisher: BioMed Central Ltd.
Journal title: Trials
Volume: 16
Thesis number: 293
Abstract: Background: Major depression is one of the most debilitating diseases in terms of quality of life. Less than half of patients suffering from depression can achieve remission after adequate antidepressant treatment. Another promising treatment option is cognitive-behavior therapy (CBT). However, the need for experienced therapists and substantive dedicated time prevent CBT from being widely disseminated. Methods/design: A multi-center randomized trial is currently being conducted since September 2014. The smartphone-based CBT program, named the "Kokoro-App, " for major depression has been developed and its feasibility has been confirmed in a previous open study. The program consists of an introduction, 6 sessions and an epilogue, and is expected to be completed within 9 weeks by patients. In the present trial, 164 patients with DSM-5 major depressive disorder and still suffering from depressive symptoms after adequate antidepressant treatment for more than 4 weeks will be allocated to the Kokoro-App plus switching antidepressant group or the switching antidepressant alone group. The participants allocated to the latter group will receive full components of the Kokoro-App after 9 weeks. Discussion: An effective and reachable intervention may not only lead to healthier mental status among depressed patients, but also to reduced social burden from this illness. This paper outlines the background and methods of a trial that evaluates the possible additive value of a smartphone-based CBT program for treatment-resistant depression. Trial registration: UMIN-CTR: UMIN000013693. (registered on 1 June 2014).
Rights: © 2015 Watanabe et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
DOI(Published Version): 10.1186/s13063-015-0805-z
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