Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial
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 interven...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-03-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/3/e33423 |
| _version_ | 1797735184645226496 |
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| author | Jan Sarlon Jessica P K Doll Aline Schmassmann Serge Brand Naomi Ferreira Markus Muehlhauser Stefanie Urech-Meyer Nina Schweinfurth Undine Emmi Lang Annette Beatrix Bruehl |
| author_facet | Jan Sarlon Jessica P K Doll Aline Schmassmann Serge Brand Naomi Ferreira Markus Muehlhauser Stefanie Urech-Meyer Nina Schweinfurth Undine Emmi Lang Annette Beatrix Bruehl |
| author_sort | Jan Sarlon |
| collection | DOAJ |
| description |
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 |
| first_indexed | 2024-03-12T12:55:25Z |
| format | Article |
| id | doaj.art-30409cd83c464a4db30e3424fbc23c36 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:55:25Z |
| publishDate | 2022-03-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-30409cd83c464a4db30e3424fbc23c362023-08-28T21:11:56ZengJMIR PublicationsJMIR Research Protocols1929-07482022-03-01113e3342310.2196/33423Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled TrialJan Sarlonhttps://orcid.org/0000-0003-0818-1830Jessica P K Dollhttps://orcid.org/0000-0002-5692-294XAline Schmassmannhttps://orcid.org/0000-0003-0632-4471Serge Brandhttps://orcid.org/0000-0003-2175-2765Naomi Ferreirahttps://orcid.org/0000-0002-0746-9659Markus Muehlhauserhttps://orcid.org/0000-0002-4295-0691Stefanie Urech-Meyerhttps://orcid.org/0000-0003-1565-5539Nina Schweinfurthhttps://orcid.org/0000-0001-7518-050XUndine Emmi Langhttps://orcid.org/0000-0002-3585-6533Annette Beatrix Bruehlhttps://orcid.org/0000-0003-4704-4986 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)DERR1-10.2196/33423https://www.researchprotocols.org/2022/3/e33423 |
| spellingShingle | Jan Sarlon Jessica P K Doll Aline Schmassmann Serge Brand Naomi Ferreira Markus Muehlhauser Stefanie Urech-Meyer Nina Schweinfurth Undine Emmi Lang Annette Beatrix Bruehl Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial JMIR Research Protocols |
| title | Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial |
| title_full | Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial |
| title_fullStr | Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial |
| title_short | Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial |
| title_sort | effectiveness of a mindfulness based mobile application for the treatment of depression in ambulatory care protocol for a randomized controlled trial |
| url | https://www.researchprotocols.org/2022/3/e33423 |
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