Adding Smartphone-based Cognitive-behavior Therapy to Pharmacotherapy for Major Depression (FLATT Project): Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2015 Jul 8

PMID 26149441

Citations 15

Authors

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

Affiliations

Soon will be listed here.

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/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.

Trial Registration: UMIN-CTR: UMIN000013693 (registered on 1 June 2014).

Citing Articles

Comparing Email Versus Text Messaging as Delivery Platforms for Supporting Patients With Major Depressive Disorder: Noninferiority Randomized Controlled Trial.

Adu M, Eboreime O, Shalaby R, Eboreime E, Agyapong B, Dias R JMIR Form Res. 2024; 8():e59003.

PMID: 39250182 PMC: 11420606. DOI: 10.2196/59003.

Smartphone Psychotherapy Reduces Fear of Cancer Recurrence Among Breast Cancer Survivors: A Fully Decentralized Randomized Controlled Clinical Trial (J-SUPPORT 1703 Study).

Akechi T, Yamaguchi T, Uchida M, Imai F, Momino K, Katsuki F J Clin Oncol. 2022; 41(5):1069-1078.

PMID: 36322882 PMC: 9928623. DOI: 10.1200/JCO.22.00699.

Adolescent Health Promotion Interventions Using Well-Care Visits and a Smartphone Cognitive Behavioral Therapy App: Randomized Controlled Trial.

Nagamitsu S, Kanie A, Sakashita K, Sakuta R, Okada A, Matsuura K JMIR Mhealth Uhealth. 2022; 10(5):e34154.

PMID: 35604760 PMC: 9171600. DOI: 10.2196/34154.

Human Support in App-Based Cognitive Behavioral Therapies for Emotional Disorders: Scoping Review.

Bernstein E, Weingarden H, Wolfe E, Hall M, Snorrason I, Wilhelm S J Med Internet Res. 2022; 24(4):e33307.

PMID: 35394434 PMC: 9034419. DOI: 10.2196/33307.

Characteristics of Mobile Health Platforms for Depression and Anxiety: Content Analysis Through a Systematic Review of the Literature and Systematic Search of Two App Stores.

Leong Q, Sridhar S, Blasiak A, Tadeo X, Yeo G, Remus A J Med Internet Res. 2022; 24(2):e27388.

PMID: 35119370 PMC: 8857696. DOI: 10.2196/27388.

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