ArticleJMIR research protocols2022
Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial.
Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05060393 (Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder), which is not on this map. Cited by 1 paper.
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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.
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Who cites it
1 citing paper in PubMed.
- Adjunctive use of mindfulness-based mobile application in depression: randomized controlled study.European archives of psychiatry and clinical neuroscience · 2025Trial
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with major depressive disorder (MDD) often experience relapses despite regular treatment with pharmacotherapy and psychotherapy. Further, long waiting lists and more demand than treatment capacity characterize ambulatory settings. Mindfulness-based interventions proved to be effective in relapse prevention in MDD. Next, mindfulness-based interventions in the form of free mobile applications can be an effective augmentation of the treatment as usual and can fill a gap in ambulatory care.
objectiveGiven this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via a mobile app on the symptom severity and stress levels, compared to treatment as usual.
methodsA total of 140 individuals with MDD will be randomly allocated to the intervention or control condition. The intervention consists of the daily use of the mindfulness mobile application Headspace for thirty days (up to 10 minutes a day). The control condition will be treatment as usual. At baseline and four weeks later, the following key outcome dimensions will be assessed: self-rated (Beck Depression Inventory) and experts' rated symptoms of MDD (Hamilton Depression Rating Scale); secondary outcome variables will be blood pressure, heart rate, and respiratory rate and changes in tobacco and alcohol consumption and medication as a proxy of perceived stress.
resultsThis study was funded in February 2021 and approved by the institutional review board on April 15, 2021, and it started in May 2021. As of December 2021, we enrolled 30 participants. The findings are expected to be published in spring 2023.
conclusionsWe hypothesize that compared to the control conditions, individuals with MDD of the mobile app-condition will have both lower self- and experts' rated symptoms of MDD and more favorable stress-related levels. While the risk for medical events is low, the immediate benefit for participants could be a decrease in symptom severity and reduction of the stress level.
trial registrationClinical Trials.gov NCT05060393; https://clinicaltrials.gov/ct2/show/NCT05060393. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33423.
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