A PLACEBO INTERVENTION FOR SMARTPHONE-BASED SELF-HELP APPS TARGETING ANXIETY AND DEPRESSION
Author(s)
Kim Rand, PhD.
Health Services Research Unit, Akershus University Hospital, Lørenskog, Norway.
Health Services Research Unit, Akershus University Hospital, Lørenskog, Norway.
OBJECTIVES: Tankevirus and Grubl are two self-help apps based on cognitive and meta-cognitive theory, available for use at no charge in Norway, based on funding from the Norwegian directorate of health. Users of both apps report substantial reduction in symptoms of anxiety and depression. However, the extent to which this is attributable to the app remains uncertain. An RCT is planned starting in 2027, comparing the two apps with a digital placebo/sham intervention. The aim of the sub-project is to develop a suitable placebo/sham intervention, which must be harmless, convincing, low cost, and impart at most limited benefit.
METHODS: The RCT will be fully online with automatic arm assignment, blinded to the investigators until analyses are complete. Participants will necessarily see the intervention to which they are assigned but will not be informed of the other trial arms. The placebo app will include all structural elements of the active treatment arms, including video-based instructions, reminders, and self-reporting modules. It will start with a short video explaining the merits of attention training technique (ATT), an actual therapeutic framework in which patients train intensively over prolonged periods using highly demanding attention tasks. The sham intervention instead involves a set of very brief attention-requiring games, which are expected to be harmless and to provide negligible positive impact.
RESULTS: A set of candidate mini-games has been developed and will be tested for feasibility and acceptability in a panel of users and researchers. The mini-games will be presented and discussed to gather feedback and ideas for refinement and potential new candidates.
CONCLUSIONS: What constitutes a real “placebo” in the world of digital self-help apps is not self-evident. The candidate mini-games under development could be applicable to other RCTs of other self-help apps.
METHODS: The RCT will be fully online with automatic arm assignment, blinded to the investigators until analyses are complete. Participants will necessarily see the intervention to which they are assigned but will not be informed of the other trial arms. The placebo app will include all structural elements of the active treatment arms, including video-based instructions, reminders, and self-reporting modules. It will start with a short video explaining the merits of attention training technique (ATT), an actual therapeutic framework in which patients train intensively over prolonged periods using highly demanding attention tasks. The sham intervention instead involves a set of very brief attention-requiring games, which are expected to be harmless and to provide negligible positive impact.
RESULTS: A set of candidate mini-games has been developed and will be tested for feasibility and acceptability in a panel of users and researchers. The mini-games will be presented and discussed to gather feedback and ideas for refinement and potential new candidates.
CONCLUSIONS: What constitutes a real “placebo” in the world of digital self-help apps is not self-evident. The candidate mini-games under development could be applicable to other RCTs of other self-help apps.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA83
Topic
Health Technology Assessment, Medical Technologies, Study Approaches
Disease
Mental Health (including addiction)