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

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: Mindfulness-based cognitive therapy

• Registration Number: NCT05060393
• Lead Sponsor: University of Basel

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)

Detailed 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.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-10-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Mindfulness-based cognitive therapy	Daily use of mindfulness-based mobile application for 30 days.

Primary Outcome Measures

Name	Time	Method
Change from baseline self reported Depression Severity	30 days	Beck Depression Inventory
Change from Baseline Depression Severity	30 days	Hamilton Depression Rating Scale

Secondary Outcome Measures

Name	Time	Method
Change from baseline heart rate	30 days	Change in resting heart rate
Change in consumption of anxiolytics	30 days	Change in daily use of anxiolytic drugs
Change from baseline blood pressure	30 days	Change in systolic blood pressure
Change from baseline respiratory rate	30 days	Change in resting respiratory rate
Change from baseline tobacco consumption	30 days	Change in daily tobacco consumption
Change from baseline alcohol consumption	30 days	Change in weekly alcohol consumption

Trial Locations

Locations (1)

Jan Sarlon; 🇨🇭 Basel, Switzerland