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 language | English |
|---|---|
| Article number | 293 |
| Journal | Trials |
| Volume | 16 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jul 7 2015 |
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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 journal › Article
}
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
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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 -