Trial reportTrials2015
Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Next-Generation Cognitive-Behavioral Therapy for Depression: Integrating Digital Tools, Teletherapy, and Personalization for Enhanced Mental Health Outcomes.Medicina (Kaunas, Lithuania) · 2025Pooled it
- 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.Journal of medical Internet research · 2022Pooled it
- Smartphone Apps for the Treatment of Mental Disorders: Systematic Review.JMIR mHealth and uHealth · 2020Pooled it
- A Systematic Review of Cognitive Behavioral Therapy and Behavioral Activation Apps for Depression.PloS one · 2016Pooled it
- Comparing Email Versus Text Messaging as Delivery Platforms for Supporting Patients With Major Depressive Disorder: Noninferiority Randomized Controlled Trial.JMIR formative research · 2024Trial
- Smartphone Psychotherapy Reduces Fear of Cancer Recurrence Among Breast Cancer Survivors: A Fully Decentralized Randomized Controlled Clinical Trial (J-SUPPORT 1703 Study).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Adolescent Health Promotion Interventions Using Well-Care Visits and a Smartphone Cognitive Behavioral Therapy App: Randomized Controlled Trial.JMIR mHealth and uHealth · 2022Trial
- Trial
- Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial.Journal of medical Internet research · 2017Trial
- Human Support in App-Based Cognitive Behavioral Therapies for Emotional Disorders: Scoping Review.Journal of medical Internet research · 2022Article
- Mobile health applications for mental illnesses: An Asian context.Asian journal of psychiatry · 2020Review
- Behavioral Activation Contributed to the Total Reduction of Depression Symptoms in the Smartphone-based Cognitive Behavioral Therapy: A Secondary Analysis of a Randomized, Controlled Trial.Innovations in clinical neuroscience · 2020Review
- An mHealth Platform for Supporting Clinical Data Integration into Augmentative and Alternative Communication Service Delivery: User-Centered Design and Usability Evaluation.JMIR rehabilitation and assistive technologies · 2018Article
- A guideline for whom?Epidemiology and psychiatric sciences · 2016Article
- Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis.Neurology(R) neuroimmunology & neuroinflammation · 2015Article
- Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends.Indian journal of psychological medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMajor 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/
designA 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 registrationUMIN-CTR: UMIN000013693 (registered on 1 June 2014).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.