The Safety of Digital Mental Health Interventions: Systematic Review and Recommendations

被引:12
作者
Taher, Rayan [1 ]
Hsu, Che-Wei [1 ]
Hampshire, Chloe [2 ]
Fialho, Carolina [1 ]
Heaysman, Clare [3 ]
Stahl, Daniel [1 ]
Shergill, Sukhi [4 ]
Yiend, Jenny [1 ]
机构
[1] Kings Coll London, Inst Psychiat Psychol & Neurosci IoPPN, Psychosis Studies Dept, 16 De Crespigny Pk, London SE5 8AB, England
[2] Univ Bath, Dept Psychol, Bath, England
[3] Kings Coll London, London Inst Healthcare Engn, London, England
[4] Kent & Medway Med Sch, Canterbury, Kent, England
来源
JMIR MENTAL HEALTH | 2023年 / 10卷
基金
英国医学研究理事会;
关键词
COGNITIVE-BEHAVIORAL THERAPY; VIRTUAL-REALITY; PSYCHOTIC DISORDERS; CONTROLLED-TRIAL; SINGLE-BLIND; FEASIBILITY; AVOIDANCE;
D O I
10.2196/47433
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
Background: Evidence suggests that digital mental health interventions (DMHIs) for common mental health conditions are effective. However, digital interventions, such as face-to-face therapies, pose risks to patients. A safe intervention is considered one in which the measured benefits outweigh the identified and mitigated risks.Objective: This study aims to review the literature to assess how DMHIs assess safety, what risks are reported, and how they are mitigated in both the research and postmarket phases and building on existing recommendations for assessing, reporting, and mitigating safety in the DMHI and standardizing practice.Methods: PsycINFO, Embase, and MEDLINE databases were searched for studies that addressed the safety of DMHIs. The inclusion criteria were any study that addressed the safety of a clinical DMHI, even if not as a main outcome, in an adult population, and in English. As the outcome data were mainly qualitative in nature, a meta-analysis was not possible, and qualitative analysis was used to collate the results. Quantitative results were synthesized in the form of tables and percentages. To illustrate the use of a single common safety metric across studies, we calculated odds ratios and CIs, wherever possible.Results: Overall, 23 studies were included in this review. Although many of the included studies assessed safety by actively collecting adverse event (AE) data, over one-third (8/23, 35%) did not assess or collect any safety data. The methods and frequency of safety data collection varied widely, and very few studies have performed formal statistical analyses. The main treatment-related reported AE was symptom deterioration. The main method used to mitigate risk was exclusion of high-risk groups. A secondary web-based search found that 6 DMHIs were available for users or patients to use (postmarket phase), all of which used indications and contraindications to mitigate risk, although there was no evidence of ongoing safety review.Conclusions: The findings of this review show the need for a standardized classification of AEs, a standardized method for assessing AEs to statically analyze AE data, and evidence-based practices for mitigating risk in DMHIs, both in the research and postmarket phases. This review produced 7 specific, measurable, and achievable recommendations with the potential to have an immediate impact on the field, which were implemented across ongoing and future research. Improving the quality of DMHI safety data will allow meaningful assessment of the safety of DMHIs and confidence in whether the benefits of a new DMHI outweigh its risks.
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页数:20
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  • [1] [Anonymous], 2023, What is a serious adverse event?
  • [2] [Anonymous], 2021, Digital clinical safety strategy
  • [3] Internet-based behavioural activation with lay counsellor support versus online minimal psychoeducation without support for treatment of depression: a randomised controlled trial in Indonesia
    Arjadi, Retha
    Nauta, Maaike H.
    Scholte, Willem F.
    Hollon, Steven D.
    Chowdhary, Neerja
    Suryani, Angela O.
    Uiterwaal, Cuno S. P. M.
    Bockting, Claudi L. H.
    [J]. LANCET PSYCHIATRY, 2018, 5 (09): : 707 - 716
  • [4] assets.publishing, Pharmacovigilance - how the MHRA monitors the safety of medicines
  • [5] Rates and Predictors of Deterioration in a Trial of Internet-Delivered Cognitive Behavioral Therapy for Reducing Suicidal Thoughts
    Batterham, Philip J.
    Christensen, Helen
    Calear, Alison L.
    Werner-Seidler, Aliza
    Kazan, Dominique
    [J]. ARCHIVES OF SUICIDE RESEARCH, 2022, 26 (02) : 937 - 947
  • [6] Ecological Momentary Assessment and Intervention in the Treatment of Psychotic Disorders: A Systematic Review
    Bell, Imogen H.
    Lim, Michelle H.
    Rossell, Susan L.
    Thomas, Neil
    [J]. PSYCHIATRIC SERVICES, 2017, 68 (11) : 1172 - 1181
  • [7] Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry
    Bergin, Aislinn D. Gomez
    Valentine, Althea Z.
    Rennick-Egglestone, Stefan
    Slade, Mike
    Hollis, Chris
    Hall, Charlotte L.
    [J]. JMIR MENTAL HEALTH, 2023, 10
  • [8] The elephant on the couch: side-effects of psychotherapy
    Berk, Michael
    Parker, Gordon
    [J]. AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY, 2009, 43 (09) : 787 - 794
  • [9] Condensed Internet-delivered prolonged exposure provided soon after trauma: a randomised trial
    Bragesjo, Maria
    Arnberg, Filip K.
    Lauri, Klara Olofsdotter
    Aspvall, Kristina
    Sarnholm, Josefin
    Andersson, Erik
    [J]. PSYCHOLOGICAL MEDICINE, 2023, 53 (05) : 1989 - 1998
  • [10] The development of National Safety and Quality Digital Mental Health Standards
    Brown, Peggy
    Prest, Ben
    Miles, Paul
    Rossi, Vanessa
    [J]. AUSTRALASIAN PSYCHIATRY, 2022, 30 (02) : 154 - 157