PMID- 35357325
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 11
IP  - 3
DP  - 2022 Mar 31
TI  - Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of 
      Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial.
PG  - e33423
LID - 10.2196/33423 [doi]
LID - e33423
AB  - 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 proved to be effective in 
      relapse prevention in MDD. Next, mindfulness-based interventions in the form of 
      free mobile applications can be an effective augmentation of the treatment as 
      usual and can fill a gap in ambulatory care. OBJECTIVE: Given this background, 
      the aim of this randomized controlled study is to assess the effectiveness of 
      additional MBI via a mobile app on the symptom severity and stress levels, 
      compared to treatment as usual. 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); secondary outcome variables 
      will be blood pressure, heart rate, and respiratory rate and changes in tobacco 
      and alcohol consumption and medication as a proxy of perceived stress. RESULTS: 
      This study was funded in February 2021 and approved by the institutional review 
      board on April 15, 2021, and it started in May 2021. As of December 2021, we 
      enrolled 30 participants. The findings are expected to be published in spring 
      2023. 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 in symptom severity and reduction of the stress level. TRIAL 
      REGISTRATION: Clinical Trials.gov NCT05060393; 
      https://clinicaltrials.gov/ct2/show/NCT05060393. INTERNATIONAL REGISTERED REPORT 
      IDENTIFIER (IRRID): DERR1-10.2196/33423.
CI  - (c)Jan Sarlon, Jessica P K Doll, Aline Schmassmann, Serge Brand, Naomi Ferreira, 
      Markus Muehlhauser, Stefanie Urech-Meyer, Nina Schweinfurth, Undine Emmi Lang, 
      Annette Beatrix Bruehl. Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 31.03.2022.
FAU - Sarlon, Jan
AU  - Sarlon J
AUID- ORCID: 0000-0003-0818-1830
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Doll, Jessica P K
AU  - Doll JPK
AUID- ORCID: 0000-0002-5692-294X
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Schmassmann, Aline
AU  - Schmassmann A
AUID- ORCID: 0000-0003-0632-4471
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Brand, Serge
AU  - Brand S
AUID- ORCID: 0000-0003-2175-2765
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
AD  - Department of Sport, Exercise and Health, Faculty of Medicine, University of 
      Basel, Basel, Switzerland.
AD  - Sleep Disorders Research Center, Kermanshah University of Medical Sciences, 
      Kermanshah, Iran.
FAU - Ferreira, Naomi
AU  - Ferreira N
AUID- ORCID: 0000-0002-0746-9659
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Muehlhauser, Markus
AU  - Muehlhauser M
AUID- ORCID: 0000-0002-4295-0691
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Urech-Meyer, Stefanie
AU  - Urech-Meyer S
AUID- ORCID: 0000-0003-1565-5539
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Schweinfurth, Nina
AU  - Schweinfurth N
AUID- ORCID: 0000-0001-7518-050X
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Lang, Undine Emmi
AU  - Lang UE
AUID- ORCID: 0000-0002-3585-6533
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
FAU - Bruehl, Annette Beatrix
AU  - Bruehl AB
AUID- ORCID: 0000-0003-4704-4986
AD  - University Psychiatric Clinics, University of Basel, Basel, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT05060393
PT  - Journal Article
DEP - 20220331
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC9015747
OTO - NOTNLM
OT  - depression
OT  - ehealth
OT  - mhealth
OT  - mindfulness
OT  - stress level
COIS- Conflicts of Interest: None declared.
EDAT- 2022/04/01 06:00
MHDA- 2022/04/01 06:01
PMCR- 2022/03/31
CRDT- 2022/03/31 12:04
PHST- 2021/10/12 00:00 [received]
PHST- 2022/01/23 00:00 [accepted]
PHST- 2022/01/13 00:00 [revised]
PHST- 2022/03/31 12:04 [entrez]
PHST- 2022/04/01 06:00 [pubmed]
PHST- 2022/04/01 06:01 [medline]
PHST- 2022/03/31 00:00 [pmc-release]
AID - v11i3e33423 [pii]
AID - 10.2196/33423 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2022 Mar 31;11(3):e33423. doi: 10.2196/33423.