Generalized anxiety disorder: Do apps help people affected cope with their condition? [Internet]

Excerpt

Research question of the HTA report: The following research questions arise:

1. What is the benefit of digital health applications (DiGA, including apps) for the treatment of generalized anxiety disorder (GAD) in adolescents and adults of all sexes compared to sham treatment, other treatment, or a no-treatment approach in terms of patient-relevant outcomes?

2. What are the direct costs of the assessed interventions from the perspective of the community of people insured by statutory health insurance?

3. How does the cost-effectiveness of the intervention compare to the comparator intervention?

4. What ethical, social, legal, and organizational aspects arise in connection with the selection and implementation of interventions?

Conclusion of the HTA report: The current study situation provides indications of a benefit of digital interventions based on cognitive behavioural therapy in comparison with no treatment in terms of disease-related symptoms, quality of life, and everyday functions. However, all included studies show a high risk of bias, which limits the certainty of the results. There is no hint of (greater or lesser) benefit for the outcome of GAD diagnosis (remission), and no data were reported for the outcomes of mortality, risk of relapse, and self-efficacy. There are also no hints regarding the potential for harm, as hardly any adverse events were recorded in the studies. For another intervention investigated – based on a mixture of cognitive behavioural therapy and cognitive bias modification – there was a hint of a benefit in terms of GAD diagnosis (remission), but not in terms of GAD-related symptoms (the other outcomes were not examined for this intervention). For all other comparisons – digital interventions based on cognitive bias modification in comparison with sham interventions and head-to-head comparisons between digital interventions with different designs – there are no hints of (greater or lesser) benefit in relation to any of the outcomes analysed.

In Germany, digital interventions without therapeutic support or with only rudimentary personal support are lower in cost than face-to-face individual psychotherapy, but, depending on the product, they can be more expensive than drug therapy. The 2 economic studies identified do not allow conclusions to be derived on the cost-effectiveness of digital interventions for the German health care system.

From an ethical perspective, on the one hand there is the expectation that digital interventions can lead to improvements in access to health care services (e.g. during the waiting time for a therapy place) and generate gains in autonomy and self-determination if their effectiveness is sufficiently proven. On the other hand, these positive effects can only occur across different target groups if the implementation of appropriate accompanying measures is ensured and digital interventions are designed to suit the target group. In this context, accompanying (qualitative) research is important. Furthermore, patient preferences not only attach great importance to the individualization of the digital offering, but also to personal (i.e. non-digital) support. Not all affected individuals can be reached with digital interventions, and the individual and well-informed decision (for or against the use of a DI or for the selection of a specific digital intervention out of the available ones) is particularly important across different age groups and socioeconomic groups. This further emphasizes the need for transparent information about digital treatment options and their framework conditions, including the legal regulations on data protection and product safety, both for those affected and for healthcare professionals. Clarification is needed of the different legal frameworks that apply depending on whether a digital intervention is declared as a medical device or not. From an organizational point of view, it is relevant that a considerable proportion of physicians and psychotherapists rate their own knowledge of DiGA as insufficient.

Missing data: With most studies lasting 2–3 months, no data are available on longer-term effects. None of the randomized controlled trials included a comparison with face-to-face psychotherapy (individual or group setting) or pharmacotherapy, and none of the included studies examined adolescents aged 14 years and older. Very few studies recorded adverse events, and if they did, it was often not done systematically.

Need for research: Valuable further insights could come from high-quality studies that (1) conduct longer-term follow-up surveys in intervention and control groups, (2) that also systematically assess quality of life and, in particular, potential adverse events, and (3) that directly compare digital interventions based on cognitive behavioural therapy with face-to-face cognitive behavioural therapy. It is difficult or impossible to perform blinding and assess the outcomes objectively given the present research question. Therefore, a high risk of bias is also to be expected in future studies. This makes it all the more important to avoid further risks of bias – including deviations from study protocols and financial conflicts of interest of the authors in the studies included here.

In addition, the group of (children and) adolescents should be investigated in studies due to the prevalence and incidence of generalized anxiety disorder and the limited possibility of drug treatment.

A high number of ongoing studies is to be assumed.

Summary conclusion: Individuals with generalized anxiety disorder can benefit from digital interventions based on cognitive behavioural therapy, at least in the short term (average observation period 3 months). Meta-analyses with up to 14 studies provide indications of a benefit in reducing disease-related symptoms in comparison with no treatment as well as an improvement in quality of life and everyday functions. However, the current study situation does not allow any conclusions to be drawn about the long-term effects or possible adverse effects of digital interventions based on cognitive behavioural therapy. It is important for those affected and for health professionals that DIs are designed and used in a way that is appropriate for the target group, and that transparent and sufficient information is provided and disseminated about the treatment options and their framework conditions (including data protection and product safety regulations).