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

September 17, 2021 updated by: Jan Sarlon, University of Basel
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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline self reported Depression Severity
Time Frame: 30 days
Beck Depression Inventory
30 days
Change from Baseline Depression Severity
Time Frame: 30 days
Hamilton Depression Rating Scale
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline heart rate
Time Frame: 30 days
Change in resting heart rate
30 days
Change from baseline blood pressure
Time Frame: 30 days
Change in systolic blood pressure
30 days
Change from baseline respiratory rate
Time Frame: 30 days
Change in resting respiratory rate
30 days
Change from baseline tobacco consumption
Time Frame: 30 days
Change in daily tobacco consumption
30 days
Change from baseline alcohol consumption
Time Frame: 30 days
Change in weekly alcohol consumption
30 days
Change in consumption of anxiolytics
Time Frame: 30 days
Change in daily use of anxiolytic drugs
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Investigators

  • Principal Investigator: Jan Sarlon, University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All of the individual participant data collected during the trial will be shared, after deidentification.

IPD Sharing Time Frame

Immediately following publication and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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