TY - JOUR
T1 - Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project)
T2 - Study protocol for a randomized controlled trial
AU - On behalf of steering committee of the Fun to Learn to Act and Think through Technology (FLATT) project
AU - Watanabe, Norio
AU - Horikoshi, Masaru
AU - Yamada, Mitsuhiko
AU - Shimodera, Shinji
AU - Akechi, Tatsuo
AU - Miki, Kazuhira
AU - Inagaki, Masatoshi
AU - Yonemoto, Naohiro
AU - Imai, Hissei
AU - Tajika, Aran
AU - Ogawa, Yusuke
AU - Takeshima, Nozomi
AU - Hayasaka, Yu
AU - Furukawa, Toshi A.
N1 - Funding Information:
TAF has received lecture fees from Eli Lilly, Meiji, Mochida, MSD, Otsuka, Pfizer and Tanabe-Mitsubishi, and consultancy fees from Sekisui Chemicals and Takeda Science Foundation. He has received royalties from Igaku-Shoin, Seiwa-Shoten and Nihon Bunka Kagaku-sha publishers. He has received grant or research support from the Japanese Ministry of Education, Science, and Technology, the Japanese Ministry of Health, Labor and Welfare, the Japan Foundation for Neuroscience and Mental Health, Mochida and Tanabe-Mitsubishi. He is a diplomate of the Academy of Cognitive Therapy.
Funding Information:
This study has been supported by a Grant-in-Aid from the Ministry of Health, Labor and Welfare Japan (H22-Seishin-Ippan-008) between 2010 and 2011, and by a grant for “Research Project for Pragmatic Psychopharmacological Treatment” by the Japan Foundation for Neuroscience and Mental Health since 2012. The Project has received donations from Asahi Kasei Pharma Corp., Eli Lilly Japan KK, GlaxoSmithKline KK, Ltd., Janssen Pharmaceuticals KK, Meiji Seika Pharma Co., Mitsubishi Tanabe Pharma Corporation, MSD KK, Mochida Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Pfizer Japan Inc., Ltd. and Shionogi & Co.
Funding Information:
The authors have no conflicts of interests to declare that may be affected by the publication of the manuscript. NW has research funds from the Japanese Ministry of Health, Labor and Welfare and the Japanese Ministry of Education, Science, and Technology. He has also received royalties from Sogensha and Paquet, and speaking fees and research funds from Asahi Kasei, Dai-Nippon Sumitomo, Eli Lilly, Glaxo SmithKline, Janssen, Meiji, MSD, Otsuka and Pfizer. MH has research funds from the Japanese Ministry of Health, Labor and Welfare and the Japanese Ministry of Education, Science, and Technology. He has received royalties from Igaku Shoin, Shogakukan Shueisha Production, Shindan to Chiryosha, Sogensha, Kangokyokai Shuppan, Kitaoji Shobo and Kongo Shuppan. MY has research funds from the Japanese Ministry of Health, Labor and Welfare and the Japanese Ministry of Education, Science, and Technology. He has received honoraria for lectures from Meiji Seika Pharma, MSD, Asahi Kasei Pharma, and has contracted research with Nippon Chemiphar. He has received royalties from Igaku Shoin, Seishin Shobou, Koubundou, Sentan Igakusha. SS has received speaking fees and/or research funds from Astellas, Dainippon-Sumitomo, GlaxoSmithKline, Janssen, Lilly, MSD, Otsuka, Pfizer, Shering-Plough, Shionogi and Yoshitomi. TA has received speaking fees and/or research funds from Astellas, Astra-Zeneca, GlaxoSmithKline, Meiji, MSD, Otsuka, Pfizer, Lilly, Mochida, Tanabe, Yoshitomi , and Shionogi. He has received royalties from Igaku-Shoin, Nanzando, Dainippon-Sumitomo, Takeda, Chugai-igakusya, Kyorin medical supply and NHK enterprise. KM has received speaking fees from Astellas, Dainippon-Sumitomo, GlaxoSmithKline, Janssen, Lilly, Meiji, Otsuka, Pfizer and Shering-Plough. MI has received grants from the Ministry of Health, Labor and Welfare, personal fees from Pfizer Japan Inc., personal fees from Mochida Pharmaceutical Co., Ltd., personal fees from Shionogi & Co., Ltd., personal fees from Nippon Hyoron Sha Co., Ltd., personal fees from Nanzando Co., Ltd., personal fees from Seiwa Shoten Co., Ltd., personal fees from Igaku-shoin Ltd., and personal fees from Technomics, Inc., outside the submitted work. NY has research funds from the Japanese Society of Clinical Pharmacology and Therapeutics, the Japanese Ministry of Health, Labor and Welfare and the Japanese Ministry of Education, Science, and Technology. He also received royalties from Seiwa-Shoten, Herusu-Shupan and Arc Media. HI has no conflicts of interest to declare. AT has received honoraria for speaking at a meeting sponsored by Eli Lilly and Tanabe-Mitsubishi. YO has received research funds from the Japan Society for the Promotion of Science and speaking fees from Eli Lilly. NT has no conflicts of interest to declare. YH has no conflicts of interest to declare.
Publisher Copyright:
© 2015 Watanabe et al.
PY - 2015/7/7
Y1 - 2015/7/7
N2 - 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. In the present study, we aim to examine the effectiveness of switching antidepressants and starting a smartphone-based CBT program at the same time, in comparison to switching antidepressants only, among patients still suffering from depression after adequate antidepressant treatment. 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. The primary outcome is the change in the total score on the Patient Health Questionnaire through the 9 weeks of the program, as assessed at week 0, 1, 5 and 9 via telephone by blinded raters. The secondary outcomes include the change in the total score of the Beck Depression Inventory-II, change in side effects as assessed by the Frequency, Intensity and Burden of Side Effects Rating, and treatment satisfaction. 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.
AB - 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. In the present study, we aim to examine the effectiveness of switching antidepressants and starting a smartphone-based CBT program at the same time, in comparison to switching antidepressants only, among patients still suffering from depression after adequate antidepressant treatment. 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. The primary outcome is the change in the total score on the Patient Health Questionnaire through the 9 weeks of the program, as assessed at week 0, 1, 5 and 9 via telephone by blinded raters. The secondary outcomes include the change in the total score of the Beck Depression Inventory-II, change in side effects as assessed by the Frequency, Intensity and Burden of Side Effects Rating, and treatment satisfaction. 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.
KW - Behavior therapy
KW - Cognitive therapy
KW - Computer-assisted therapy
KW - Depression
KW - Randomized controlled trials
UR - http://www.scopus.com/inward/record.url?scp=84937036323&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84937036323&partnerID=8YFLogxK
U2 - 10.1186/s13063-015-0805-z
DO - 10.1186/s13063-015-0805-z
M3 - Article
C2 - 26149441
AN - SCOPUS:84937036323
VL - 16
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 293
ER -