Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
1 other identifier
interventional
140
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedSeptember 29, 2021
September 1, 2021
1.4 years
September 8, 2021
September 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline self reported Depression Severity
Beck Depression Inventory
30 days
Change from Baseline Depression Severity
Hamilton Depression Rating Scale
30 days
Secondary Outcomes (6)
Change from baseline heart rate
30 days
Change from baseline blood pressure
30 days
Change from baseline respiratory rate
30 days
Change from baseline tobacco consumption
30 days
Change from baseline alcohol consumption
30 days
- +1 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALDaily use of mindfulness-based mobile application for 30 days.
Control group
NO INTERVENTIONTreatment as usual
Interventions
Mobile application, mindfulness-based therapy
Eligibility Criteria
You may qualify if:
- Depression, current ill
You may not qualify if:
- acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jan Sarlon
Basel, Switzerland
Related Publications (1)
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.
PMID: 35357325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Sarlon
University of Basel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 8, 2021
First Posted
September 29, 2021
Study Start
May 1, 2021
Primary Completion
October 1, 2022
Study Completion
January 1, 2023
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Immediately following publication and ending 5 years following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal.
All of the individual participant data collected during the trial will be shared, after deidentification.