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

NCT ID: NCT05060393

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Mindfulness-based cognitive therapy

Intervention Type BEHAVIORAL

Mobile application, mindfulness-based therapy

Control group

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based cognitive therapy

Mobile application, mindfulness-based therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Jan Sarlon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Sarlon

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

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Jan Sarlon

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Jan Sarlon

Role: CONTACT

+41613255381

Facility Contacts

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Jan Sarlon

Role: primary

+41613255381

References

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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.

Reference Type DERIVED
PMID: 35357325 (View on PubMed)

Other Identifiers

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202100452

Identifier Type: -

Identifier Source: org_study_id

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