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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jan SarlonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Daily use of mindfulness-based mobile application for 30 days.

Treatment as usual

Outcomes

Primary Outcome Measures

Change from baseline self reported Depression Severity
Beck Depression Inventory
Change from Baseline Depression Severity
Hamilton Depression Rating Scale

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2021
Last Updated
September 17, 2021
Sponsor
University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT05060393
Brief Title
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Official Title
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Daily use of mindfulness-based mobile application for 30 days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy
Intervention Description
Mobile application, mindfulness-based therapy
Primary Outcome Measure Information:
Title
Change from baseline self reported Depression Severity
Description
Beck Depression Inventory
Time Frame
30 days
Title
Change from Baseline Depression Severity
Description
Hamilton Depression Rating Scale
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change from baseline heart rate
Description
Change in resting heart rate
Time Frame
30 days
Title
Change from baseline blood pressure
Description
Change in systolic blood pressure
Time Frame
30 days
Title
Change from baseline respiratory rate
Description
Change in resting respiratory rate
Time Frame
30 days
Title
Change from baseline tobacco consumption
Description
Change in daily tobacco consumption
Time Frame
30 days
Title
Change from baseline alcohol consumption
Description
Change in weekly alcohol consumption
Time Frame
30 days
Title
Change in consumption of anxiolytics
Description
Change in daily use of anxiolytic drugs
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Sarlon
Phone
+41613255381
Email
jan.sarlon@upk.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sarlon
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jan Sarlon
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Sarlon
Phone
+41613255381
Email
jan.sarlon@upk.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35357325
Citation
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.
Results Reference
derived

Learn more about this trial

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

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