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The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)
Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Daily use of mindfulness-based mobile application for 30 days. |
|
| Control group | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based cognitive therapy | Behavioral | Mobile application, mindfulness-based therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline self reported Depression Severity | Beck Depression Inventory | 30 days |
| Change from Baseline Depression Severity | Hamilton Depression Rating Scale | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline heart rate | Change in resting heart rate | 30 days |
| Change from baseline blood pressure | Change in systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Sarlon | Contact | +41613255381 | jan.sarlon@upk.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jan Sarlon | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Sarlon | Recruiting | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35357325 | Derived | Sarlon J, Doll JPK, Schmassmann A, Brand S, Ferreira N, Muehlhauser M, Urech-Meyer S, Schweinfurth N, Lang UE, Bruehl AB. Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 31;11(3):e33423. doi: 10.2196/33423. |
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All of the individual participant data collected during the trial will be shared, after deidentification.
Immediately following publication and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| 30 days |
| Change from baseline respiratory rate | Change in resting respiratory rate | 30 days |
| Change from baseline tobacco consumption | Change in daily tobacco consumption | 30 days |
| Change from baseline alcohol consumption | Change in weekly alcohol consumption | 30 days |
| Change in consumption of anxiolytics | Change in daily use of anxiolytic drugs | 30 days |
| D004191 |
| Behavioral Disciplines and Activities |