Digitally enabled therapies for adults with anxiety disorders: early value assessment

Mental health services are in high demand and access varies widely across the NHS. Because of this high demand, many people are not getting the treatment and support they need. The patient experts reported many barriers to face-to-face treatment, including transport costs, travel issues and difficulty taking time off work to attend sessions. Digitally enabled therapies allow more flexible access to therapy and could fulfil a need for support. This could help some people access treatment earlier, which could improve symptoms, prevent their symptoms getting worse, and help with daily living and productivity. Some people may prefer digitally enabled therapies over other treatment options in standard care. Digitally enabled therapies may especially benefit people who are socially anxious or are unable to leave home for treatment. They may reduce the time needed by mental health professionals to deliver treatment, which could free up clinical resources that could be allocated elsewhere in the services to increase access or reduce waiting times. The committee concluded that there is an unmet clinical need and that access to effective mental health treatments needs to be improved.

Digitally enabled therapies would be used in NHS Talking Therapies for anxiety and depression with existing service protocols. Many technologies included in this assessment are being used in the NHS or have planned pilots for use. The committee acknowledged that a recommendation for use with further evidence generation would support increased adoption of these technologies and provide a mechanism for collecting real-world clinical efficacy data.

The committee carefully considered the safety and risks of using these technologies while further evidence is generated. The clinical experts advised that NHS Talking Therapies for anxiety and depression services have established protocols, which include initial clinical assessment, matching the right treatment to people's needs and preferences, and ongoing monitoring and management of patient safety. Some digitally enabled therapies also have inbuilt functionalities to promote safety, for example technologies may alert the practitioner or therapist of potential concerns so that they can contact the patient when needed. The practitioner or therapist may also contact the patient if they see worsening in patient reported outcomes or if the patient has stopped using the programme. Decline in mental health or functioning while using digitally enabled therapies should be identified by the practitioner or therapist and treatment should be increased when needed, in line with the stepped care approach.

The clinical experts advised that digitally enabled therapies may need less practitioner or therapist time than other interventions, such as face-to-face therapy. Practitioner or therapist support would usually involve a review of patient progress, the completed content and patient safety. This review may be done using messaging or sometimes a telephone call.

Practitioners and therapists need training and support to effectively deliver digitally enabled therapies. Healthcare professionals working in NHS Talking Therapies for anxiety and depression have ongoing supervision to ensure the quality of treatment and to provide support to practitioners and therapists in the delivery of assessments and treatment. The clinical experts advised that practitioners and therapists also need to be comfortable using digital technologies and need to have access to the necessary systems. Technologies should be integrated into a service's system rather than being a standalone technology. This would help with data collection and reporting. It is also important for healthcare professionals to have confidence in the effectiveness of digitally enabled therapies compared with other treatment options. This can be strengthened by developing and maintaining robust quality assurance processes. There is more information on implementing digitally enabled therapies in the adoption report within the supporting documentation on the NICE website.

Digitally enabled therapies can increase treatment options and offer people more choice in their mental healthcare. The patient experts shared that this could help people feel they are taking responsibility for their treatment and may create a sense of achievement. People who want to use digitally enabled therapies are more likely to engage with the content and to see benefits. Digitally enabled therapies may not be suitable for everyone. People who need more support or who have more severe functional impairment may need more intensive interventions. Treatment options should be discussed by healthcare professionals, patients and (when appropriate) carers and should consider clinical assessment, patient preferences and needs, and the level of support needed.

Patient experts said that appropriate privacy and security measures should be in place to reassure people using the technology. People would also need to be told about any additional support measures in place, especially when the technology is used outside of working hours. People should discuss any concerns with using digitally enabled therapies with their practitioner or therapist before starting treatment.

Digitally enabled therapy may not be suitable for everyone. It is delivered through a smart device or computer with internet connectivity. Adults with limited access to these technologies or who are less comfortable or skilled at using digital technologies may be less likely to benefit from digitally enabled therapies. They may need considerable adaptations to access the therapy, which may not be available in all services. The committee concluded that other treatment options such as face-to-face therapy may be more appropriate for some adults with anxiety disorders.

Additional support and resources may also be needed for people with visual or hearing impairments, problems with manual dexterity or who are unable to read or understand English. The companies said that they are taking steps to improve the accessibility and inclusivity of the technologies, including having a low reading age for the content, audio playback and consideration of diversity and inclusivity in their design. OxCADAT has translated its iCT‑SAD programme into other languages and other companies are also exploring this for theirs. One company said that its programme has also been used with in-person translators. Companies should also consider how to adapt their technologies to be inclusive of all cultures and suitable for use in diverse populations.

There was relevant published evidence, showing a potential benefit for adults with anxiety disorders, for 6 of the 11 digitally enabled therapies:

• Perspectives for body dysmorphic disorder (BDD)

• Beating the Blues and Space from Anxiety for generalised anxiety symptoms or unspecified anxiety disorder

• iCT‑PTSD and Spring for post-traumatic stress disorder (PTSD)

• iCT‑SAD for social anxiety disorder.
  
  There was no relevant published evidence for:

• Cerina, Iona Mind, Minddistrict, Resony and Wysa for generalised anxiety disorder (GAD) or generalised anxiety symptoms

• Cerina, Minddistrict and Space from OCD for obsessive compulsive disorder (OCD)

• Minddistrict and SilverCloud for health anxiety, panic disorder with or without agoraphobia, social anxiety disorder, and phobias.

The evidence consisted of 19 published studies, specifically 4 randomised controlled trials, 1 comparative observational cohort study, 12 single-arm studies with no direct comparator, and 2 secondary analyses of randomised controlled trials. The EAG reported that the digitally enabled therapies were found to reduce anxiety symptoms in the anxiety disorders they were designed to treat. The limited comparative evidence showed larger reductions in anxiety symptoms with digitally enabled therapies than waitlist controls or usual care. The EAG noted that waitlist controls were not in scope as a standard care comparator. This should be considered when interpreting these outcomes. Spring had outcomes comparable to standard care interventions for PTSD, as did iCT-SAD for social anxiety disorder. The EAG advised that it was not appropriate to generalise evidence from specific technologies to other digitally enabled therapies or conditions. The committee also considered unpublished and real-world evidence from the technologies' use in NHS Talking Therapies for anxiety and depression services. It concluded that the evidence base was limited for all of them, but the available evidence suggested potential benefits that could address the unmet needs. See the assessment report on the NICE website for further details.

The simple decision tree model showed that digitally enabled therapies could be a cost effective option for adults with anxiety disorders when compared with standard care in NHS Talking Therapies for anxiety and depression services. Specifically:

• Perspectives for BDD

• Beating the Blues, Minddistrict and SilverCloud for generalised anxiety symptoms or unspecified anxiety disorder

• iCT-PTSD and Spring for PTSD

• iCT-SAD, Minddistrict and SilverCloud for social anxiety disorder.
  
  See the assessment report on the NICE website for a detailed description of the model.

There was no published evidence on Minddistrict or SilverCloud for treating social anxiety disorder. The EAG estimated the possible cost effectiveness of Minddistrict for this indication using unpublished data from 2 NHS Talking Therapies for anxiety and depression services. The cost modelling for SilverCloud used clinical effectiveness from a study by Richards et al. 2020, which included a heterogeneous population of people with anxiety and depression. There was not enough evidence on the efficacy of Cerina, Iona Mind, Resony and Wysa to model their cost effectiveness.

The EAG's model included estimated technology licence costs in the digitally enabled therapies arm, healthcare professional costs based on staff grade and time needed to deliver the intervention, and the clinical effectiveness of the interventions. The assumptions used in the model are outlined in tables 15 and 17 of the assessment report. The EAG noted that a main driver of the model was the clinical effectiveness of the technologies. The limitations and uncertainties in the clinical evidence therefore created limitations and uncertainties in the economic model. Other limitations of the model also increased the uncertainty of the results (see sections 9.3 to 9.5 of the assessment report). The committee considered that, despite these limitations, digitally enabled therapies were likely to cost less than standard care because they needed less therapist time than other NHS Talking Therapies for anxiety and depression interventions. But if they are less effective, they may be more costly in the long term. Further evidence on clinical effectiveness and resource use is needed to reduce uncertainty in the cost modelling.

For technologies with published evidence, important evidence gaps relate to the population, comparators and main outcomes. The committee concluded that there was enough evidence of a potential benefit of these technologies for them to be used in the NHS while further evidence is generated to address these gaps. Important evidence gaps for these technologies are:

• Population: there was no relevant published evidence on using the technologies for health anxiety, OCD, panic disorder or phobias. Several technologies were indicated for GAD but the studies included people with generalised anxiety symptoms, depression or anxiety, or mixed depression and anxiety. The clinical experts advised that adults with anxiety disorders often have comorbidities, and treatment is offered based on their presenting problem. The committee considered this in their recommendations for use while further evidence is generated in more clearly defined populations.

• Comparators: only 2 technologies had evidence comparing their clinical effectiveness with standard care interventions. More evidence is needed in the UK, preferably in NHS Talking Therapies for anxiety and depression services, comparing digitally enabled therapies with low intensity and high intensity psychological interventions that are offered in NHS Talking Therapies for anxiety and depression services for the respective anxiety disorders.

• Outcomes: NHS Talking Therapies for anxiety and depression services use specific tools and outcome measures to report outcomes for specific anxiety disorders. Some studies used measures that are not routinely collected in these services. Further evidence generation should use measures from NHS Talking Therapies for anxiety and depression to collect outcomes on the effectiveness of the treatments, the rates and reasons for disengagement and stopping treatment, further treatment and patient experiences.

• Adverse effects: the evidence did not report any adverse events related to the use of the technologies. The committee considered that few studies reported adverse events and more evidence was needed. The clinical experts said that they did not expect to see more adverse effects for digitally enabled therapies than for standard care once these were used with local service protocols. This included offering digitally enabled therapies as one of a range of treatment options for people who do not need regular in-depth safety reviews or face-to-face care.

• Technologies: there was no relevant published evidence on Cerina, Iona Mind, Minddistrict, Resony and Wysa. The committee considered unpublished evidence on Cerina and Resony but this was very limited. The committee concluded that further research was needed on these technologies before they could be recommended for use in the NHS.

• Economic modelling: the EAG noted that the economic modelling was limited by the amount and type of data available and the uncertainty of the assumptions. The uncertainties would be reduced with further evidence generation addressing the outlined evidence gaps and providing longer-term data on continued recovery and relapse.