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Cited by 7Digital Mental Health InterventionsMental Health Treatment and AccessMobile Health and mHealth Applications

Does app-based unguided self-management improve mental health literacy, patient empowerment and access to care for people with mental health impairments? Study protocol for a randomised controlled trial

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Kerber, André, Beintner, Ina, Burchert, Sebastian, Knaevelsrud, Christine·2021·BMJ Open
DOI 10.1136/bmjopen-2021-049688PMC PMC8286775
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Abstract

Introduction: Mental disorders pose a huge burden to both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in comorbidity and chronification. Besides limited resources in healthcare systems, the treatment-gap is—to a large extent—caused by within-person barriers impeding early treatment seeking. These barriers include a lack of trust in professionals, fear of stigmatisation, or the desire to cope with problems without professional help. While unguided self-management interventions are not designed to replace psychotherapy, they may support early symptom assessment and recognition by reducing within-person barriers. Digital self-management solutions may also reduce inequalities in access to care due to external factors such as regional unavailability of services. Methods and analysis: Approximately 1100 patients suffering from mild to moderate depressive, anxiety, sleep, eating or somatisation-related mental disorders will be randomised to receive either a low-threshold unguided digital self-management tool in the form of a transdiagnostic mental health app or care as usual. The primary outcomes will be mental health literacy, patient empowerment and access to care while secondary outcomes will be symptom distress and quality of life. Additional moderator and predictor variables are negative life events, personality functioning, client satisfaction, mental healthcare service use and application of self-management strategies. Data will be collected at baseline as well as 8 weeks and 6 months after randomisation. Data will be analysed using multiple imputation and analysis of covariance employing the intention-to-treat principle, while sensitivity analyses will be based on different multiple imputation parameters and a per-protocol analysis. Ethics and dissemination: Approval was obtained from the Ethics Committee of the Faculty of Educational Science and Psychology at the Freie Universität Berlin. The results will be submitted to peer-reviewed specialised journals and presented at national and international conferences. Trial registeration: The trial has been registered in the DRKS trial register (DRKS00022531);Pre-results.

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  • For MindDoc, an RCT recruiting over 1,000 participants at Freie Universität Berlin found improvements in attitudes toward mental health, self-care behaviors, healthcare utilization, and quality of life when using the app, with effect sizes between d=0.17 (OR=1.36) and d=0.37 (OR=1.96).

    “For MindDoc, an RCT recruiting over 1,000 participants at Freie Universität Berlin found improvements in attitudes toward mental health, self-care behaviors, healthcare utilization, and quality of life when using the app, with effect sizes between d=0.17 (odds ratio [OR]=1.36) and d=0.37 (OR=1.96) (Table 3) [19].”

    From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [19]

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  1. [58]Hobson CJ, Kamen J, Szostek J, et al. Stressful life events: a revision and update of the social readjustment rating scale. Int J Stress Manag 1998; 5: 1– 23. 10.1023/A:1022978019315 · DOI

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Authors
Kerber, A., Beintner, I., Burchert, S., & Knaevelsrud, C.
Affiliations
  • Freie Universität Berlin (DE)
  • MindDoc Health GmbH, Munich, Germany
Corresponding author
Kerber, André
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2021-07
Volume
11
Issue
7
Pages
e049688
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2021-049688
PMC
PMC8286775
OpenAlex
W3178311545
Cited by
7
References
63
Citations by year
2025: 1 · 2024: 2 · 2023: 4
FWCI
1.33
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by-nc)
  • Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver
Funders
MindDoc Health GmbH (See manuscript)
Topics
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
  • Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Keywords
mental health apps, mental health literacy, patient empowerment, health care access, treatment gap, transdiagnostic treatment, depressive disorders, anxiety disorders, sleep disorders, eating disorders, somatization, digital mental health interventions, quality of life, symptom distress, barriers to care
MeSH terms
Self-Management, Berlin, Health Services Accessibility, Humans, Mental Health, Patient Participation, Quality of Life, Randomized Controlled Trials as Topic, Health Literacy, Mobile Applications

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