Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project)

Study protocol for a randomized controlled trial

Norio Watanabe, Masaru Horikoshi, Mitsuhiko Yamada, Shinji Shimodera, Tatsuo Akechi, Kazuhira Miki, Masatoshi Inagaki, Naohiro Yonemoto, Hissei Imai, Aran Tajika, Yusuke Ogawa, Nozomi Takeshima, Yu Hayasaka, Toshi A. Furukawa

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number293
JournalTrials
Volume16
Issue number1
DOIs
Publication statusPublished - Jul 7 2015

Fingerprint

Cognitive Therapy
Antidepressive Agents
Randomized Controlled Trials
Depression
Drug Therapy
Treatment-Resistant Depressive Disorder
Therapeutics
Cost of Illness
Major Depressive Disorder
Smartphone
Telephone
Quality of Life
Equipment and Supplies
Health

Keywords

  • Behavior therapy
  • Cognitive therapy
  • Computer-assisted therapy
  • Depression
  • Randomized controlled trials

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project) : Study protocol for a randomized controlled trial. / Watanabe, Norio; Horikoshi, Masaru; Yamada, Mitsuhiko; Shimodera, Shinji; Akechi, Tatsuo; Miki, Kazuhira; Inagaki, Masatoshi; Yonemoto, Naohiro; Imai, Hissei; Tajika, Aran; Ogawa, Yusuke; Takeshima, Nozomi; Hayasaka, Yu; Furukawa, Toshi A.

In: Trials, Vol. 16, No. 1, 293, 07.07.2015.

Research output: Contribution to journalArticle

Watanabe, N, Horikoshi, M, Yamada, M, Shimodera, S, Akechi, T, Miki, K, Inagaki, M, Yonemoto, N, Imai, H, Tajika, A, Ogawa, Y, Takeshima, N, Hayasaka, Y & Furukawa, TA 2015, 'Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): Study protocol for a randomized controlled trial', Trials, vol. 16, no. 1, 293. https://doi.org/10.1186/s13063-015-0805-z
Watanabe, Norio ; Horikoshi, Masaru ; Yamada, Mitsuhiko ; Shimodera, Shinji ; Akechi, Tatsuo ; Miki, Kazuhira ; Inagaki, Masatoshi ; Yonemoto, Naohiro ; Imai, Hissei ; Tajika, Aran ; Ogawa, Yusuke ; Takeshima, Nozomi ; Hayasaka, Yu ; Furukawa, Toshi A. / Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project) : Study protocol for a randomized controlled trial. In: Trials. 2015 ; Vol. 16, No. 1.
@article{84e535f5e2bf410eb744bf5693fe517e,
title = "Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): Study protocol for a randomized controlled trial",
abstract = "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.",
keywords = "Behavior therapy, Cognitive therapy, Computer-assisted therapy, Depression, Randomized controlled trials",
author = "Norio Watanabe and Masaru Horikoshi and Mitsuhiko Yamada and Shinji Shimodera and Tatsuo Akechi and Kazuhira Miki and Masatoshi Inagaki and Naohiro Yonemoto and Hissei Imai and Aran Tajika and Yusuke Ogawa and Nozomi Takeshima and Yu Hayasaka and Furukawa, {Toshi A.}",
year = "2015",
month = "7",
day = "7",
doi = "10.1186/s13063-015-0805-z",
language = "English",
volume = "16",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

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 - 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.

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

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 293

ER -