Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 12, 2021
Open Peer Review Period: Oct 12, 2021 - Dec 7, 2021
Date Accepted: Jan 23, 2022
(closed for review but you can still tweet)
Effectiveness of a mindfulness-based mobile application for the treatment of depression in ambulatory care: study protocol for a randomized controlled trial
ABSTRACT
Background:
Patients with Major Depressive Disorder (MDD) often experience relapses despite regular treatment with pharmacotherapy and psychotherapy. Further, long waiting lists and more demand than treatment capacity characterize ambulatory settings. 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.
Objective:
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.
Methods:
A total of 140 individuals with MDD will be randomly allocated to the intervention or control condition. The intervention consists of the daily use of the mindfulness mobile application “Headspace” for thirty days (up to 10 minutes a day). The control condition will be treatment as usual. At baseline and four weeks later, the following key outcome dimensions will be assessed: self-rated (Beck Depression Inventory) and experts’ rated symptoms of MDD (Hamilton Depression Rating Scale; HDRS); secondary outcome variables will be: blood pressure, heart rate, and respiratory rate; changes in tobacco and alcohol consumption and medication as a proxy of perceived stress.
Results:
The study, funded in March 2021, was approved by the ethical committee (“Ethikkomission Nordwestschweiz”, EKNZ) with a final decision on 15 of April 2021, the recruitment started in Mai 2021. As of October 2021, we enrolled 26 participants. First results are expected in summer 2022.
Conclusions:
We hypothesize that compared to the control conditions, individuals with MDD of the mobile app-condition will have both lower self- and experts’ rated symptoms of MDD and more favorable stress-related levels. While the risk for medical events is low, the immediate benefit for participants could be a decrease of symptom severity and prevention of depressive relapse. Clinical Trial: Clinical Trials.gov NCT05060393. Trial Registration date 28 September 2021, retrospectively registered
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