Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

Depression Clinical Trial

Official title:

Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060393
• Other study ID #: 202100452
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2021
• Source: University of Basel
• Contact: Jan Sarlon
• Phone: +41613255381
• Email: jan.sarlon[@]upk.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Depression, current ill

Exclusion Criteria:

• acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Mindfulness-based cognitive therapy
Mobile application, mindfulness-based therapy

Locations

Country	Name	City	State
Switzerland	Jan Sarlon	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline self reported Depression Severity	Beck Depression Inventory	30 days
Primary	Change from Baseline Depression Severity	Hamilton Depression Rating Scale	30 days
Secondary	Change from baseline heart rate	Change in resting heart rate	30 days
Secondary	Change from baseline blood pressure	Change in systolic blood pressure	30 days
Secondary	Change from baseline respiratory rate	Change in resting respiratory rate	30 days
Secondary	Change from baseline tobacco consumption	Change in daily tobacco consumption	30 days
Secondary	Change from baseline alcohol consumption	Change in weekly alcohol consumption	30 days
Secondary	Change in consumption of anxiolytics	Change in daily use of anxiolytic drugs	30 days