title: Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): study protocol for a randomized controlled trial.
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. 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  UMIN-CTR: UMIN000013693 (registered on 1 June 2014).
authors.affiliation: Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan. noriowncu@gmail.com.
authors.forename: Norio
authors.initials: N
authors.lastname: Watanabe
authors.affiliation: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan. mhorikoshi@ncnp.go.jp.
authors.forename: Masaru
authors.initials: M
authors.lastname: Horikoshi
authors.affiliation: Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan. mitsu@ncnp.go.jp.
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Yamada
authors.affiliation: Department of Neuropsychiatry, Kochi Medical School, Kochi University, Kohasu, Okoh-cho, Nankokushi, Kochi, 783-8505, Japan. shimodes@kochi-u.ac.jp.
authors.forename: Shinji
authors.initials: S
authors.lastname: Shimodera
authors.affiliation: Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. takechi@med.nagoya-cu.ac.jp.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Akechi
authors.affiliation: Miki Clinic, 1-1-3 Hiranuma, Nishi-ku, Yokohama, 220-0023, Japan. k-miki@largo-yokohama.com.
authors.forename: Kazuhira
authors.initials: K
authors.lastname: Miki
authors.affiliation: Department of Neuropsychiatry, Okayama University Hospital, 2-5-1 Shikata-cho Kita-ku, Okayama, 700-8558, Japan. masatoshiinagaki@okayama-u.ac.jp.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Inagaki
authors.affiliation: Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8551, Japan. nyonemoto@gmail.com.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yonemoto
authors.affiliation: Department of Field Medicine, Kyoto University Graduate School of Medicine, 46 Shimoadachi-cho, Yoshida Sakyo-ku, Kyoto, 606-8501, Japan. ihits@hotmail.com.
authors.forename: Hissei
authors.initials: H
authors.lastname: Imai
authors.affiliation: Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. aran.tajika28@gmail.com.
authors.forename: Aran
authors.initials: A
authors.lastname: Tajika
authors.affiliation: Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. ogawa.yusuke.2u@kyoto-u.ac.jp.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Ogawa
authors.affiliation: Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. n.takeshima@gmail.com.
authors.forename: Nozomi
authors.initials: N
authors.lastname: Takeshima
authors.affiliation: Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. y.hy.hh.y3@gmail.com.
authors.forename: Yu
authors.initials: Y
authors.lastname: Hayasaka
authors.affiliation: Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. furukawa@kuhp.kyoto-u.ac.jp.
authors.forename: Toshi A
authors.initials: TA
authors.lastname: Furukawa
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000295:instrumentation* / Q000379:methods; D003131:Combined Modality Therapy; D061218:Depressive Disorder, Treatment-Resistant / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D057915:Drug Substitution; D006801:Humans; D007564:Japan; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D012107:Research Design; D000068997:Smartphone; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents