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

• Sponsor: University of Basel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05060393
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 7

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Mindfulness-based cognitive therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Daily use of mindfulness-based mobile application for 30 days.	Behavioral: Mindfulness-based cognitive therapy; Mobile application, mindfulness-based therapy
No Intervention: Control group Treatment as usual

Outcome Measures

Primary Outcome Measures

1. Change from baseline self reported Depression Severity [30 days]

   Beck Depression Inventory

2. Change from Baseline Depression Severity [30 days]

   Hamilton Depression Rating Scale

Secondary Outcome Measures

1. Change from baseline heart rate [30 days]

   Change in resting heart rate

2. Change from baseline blood pressure [30 days]

   Change in systolic blood pressure

3. Change from baseline respiratory rate [30 days]

   Change in resting respiratory rate

4. Change from baseline tobacco consumption [30 days]

   Change in daily tobacco consumption

5. Change from baseline alcohol consumption [30 days]

   Change in weekly alcohol consumption

6. Change in consumption of anxiolytics [30 days]

   Change in daily use of anxiolytic drugs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jan Sarlon	Basel		Switzerland

Sponsors and Collaborators

• University of Basel

Investigators

• Principal Investigator: Jan Sarlon, University of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Sarlon, Principal Investigator, University of Basel
• ClinicalTrials.gov Identifier: NCT05060393
• Other Study ID Numbers: 202100452
• First Posted: Sep 29, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depressive Disorder

Study Results

No Results Posted as of Sep 29, 2021