Mindset XR Module 9: Case studies

Welcome to the Mindset Extended Reality (XR) Innovation Support Programme elearning resources, which include three series delivered in conjunction with our expert Mindset-XR programme partners:


• Medical regulation

• Lived experience involvement

• Research and clinical evidence


Mindset-XR is helping to catalyse the growth of immersive digital mental health solutions in the UK, through funding, tailored support and training. It is delivered by Innovate UK and the Health Innovation Network South London (HIN).


This series focuses on research and clinical evidence, with key insights from King’s College London’s Institute of Psychiatry, Psychology and Neuroscience. Across a number of modules, these resources will guide you through your research journey, from establishing what you plan to investigate, to conducting research and disseminating your findings.


Outline


Welcome to Module 20: Case studies where researchers at KCL share their approach to using trials to test the efficacy of XR applications for people experiencing the symptoms of psychosis such as a loss of pleasure or hearing voices.


The case studies are:


  • Illuminating a joyless life: A transdiagnostic approach to anhedonia

  • VR therapy sessions for people with psychosis

  • Avatar therapy for distressing voices


Illuminating a joyless life: A transdiagnostic approach to anhedonia



This case study is a pilot study of the feasibility of an XR application to improve assessment tools in the effective treatment of anhedonia – a loss of pleasure.


In this case study, we’re focusing on:


Highlighting the clinical need

When highlighting the clinical need for a XR solution, it is important to understand how and why that need is not currently being met.


In this case, anhedonia – loss of pleasure – is a transdiagnostic problem. This means it is a problem across a group of mental disorders.


It is important to note that should a threshold for anhedonia be met, a diagnosis for severe conditions such as psychosis or depression is more likely to be made.

Identifying gaps in the literature

At the start of a study, it is important to identify gaps in the literature. For this study, it was found there were no first-hand accounts of anhedonia across depression and psychosis.


With no voice of the people with lived experience, we do not know what it feels like to have anhedonia.

The limits of existing tools

Most of the existing tools:


  • Are measuring pleasure in the lab;

  • Use standardised images on a computer screen;

  • Are developed in Western countries;

  • Are based on data samples that is lacking in diversity.

This has led to:


  • Inconsistent findings across different studies;

  • No consensus on what stops people experiencing pleasure;

  • Little progress in this field of study.
A qualitative study

To address these gaps, especially the lack of first-hand accounts, a qualitative interview study was undertaken to explore experiences of anhedonia.


  • Identify themes across people;

  • Prioritise themes in research and clinical work;

  • Help us understand how to measure pleasure;

  • Show us where we might want to look to identity the mechanisms that contribute to the lack of pleasure.
An experimental study

To overcome the limits of existing tools, a VR scenario needs to be developed which can reliably evoke pleasure.


A VR solution is preferred as it can go further than standardised images and can appeal to a diverse group of people.

What does the new tool allow us to do?

The new VR tool informed by lived experienced accounts, means the field can move forward because:


  • We can answer research questions more reliably through better assessments;

  • We can understand the impact of the interventions;

  • We can understand differences and similarities between groups of people;

  • This can help move from measuring symptoms to improving symptoms.


Summary


  • Research

    From qualitative interviews and other work, mechanisms have been identified that contribute to anhedonia.

  • Testing

    The VR environment can be used as a scenario to test whether people experience more pleasure when these mechanisms are targeted.

  • Use of VR

    If successful, VR can be used in therapeutic work and other situations where there is a loss of pleasure.

  • Results

    This case study shows that an assessment tool can move the field forward as it allows us to measure responses through targeting mechanisms.


VR therapy sessions for people with psychosis



This case study is a feasibility study for the use of different VR environments as a treatment for loss of pleasure.


In this case study, we’re focusing on:


Identifying the problem

This pilot trial study looks to use XR for people with psychosis, a severe mental health condition. It can emerge in early adulthood and for most people it has lifelong implications.


People with psychosis experience different symptoms. Both pharmacological and non-pharmacological interventions are targeting symptoms such as hearing voices and delusions.


The majority of people with psychosis experience issues with motivation and experiencing pleasure, including social contact, and have restricted display of emotions.


These difficulties may lead to poor treatment outcomes as they are a major driver of:


  • Daily activities
  • Physical health
  • Socialising
  • Vocational attainment
  • Educational attainment
  • Healthcare
The proposed solution

We wanted to use VR as we believe this medium could:


  • Improve engagement compared to traditional talking therapies as the gamification element may make the experience more enjoyable;

  • Be tailored so the individual can be exposed to what they feel is tolerable;

  • Provide a better therapy structure.


When developing the VR product, we intended to use therapy with lived experience input from the start. We used that lived experience input to create the prototype of the environment and the script of interaction with the avatar.


The VR element was part of a therapy protocol that also required therapist input. This was due to the high level of disability often found in the clients that we were planning to offer this therapy to.


V-neST therapy

We created a therapy package called V-neST. This VR prototype went through different waves of usability testing by people with lived experience.


Over time, the VR software was refined to a product that our users, the research team, the technical team and the clinicians involved were all happy with.


After this, we felt the product was ready to be tested in a pilot randomised control trial.

Intervention

It was agreed that there would be one session a week for 12 weeks lasting one hour.


The VR software supported various elements of the therapy work including psycho-education behavioural activation, pleasure forecasting, recover goal work, emotional literacy as well as real-life exposure to distressing symptoms – all supported by the therapist.

The range of VR environments

Five environments were created, each targeting one or more hypothesised mechanisms affecting motivation and pleasure difficulties including elements targeting:


  • Loss of pleasure;

  • How individuals process feedback;

  • Motivation and social interaction challenges;

  • The ability to formulate a plan;

  • The ability to formulate a plan.


The five environments were a:


  • Games room;

  • Factory with tasks;

  • Neutral environment with music but with no demands;

  • TV room;

  • Social space where they were asked to interact with two others avatars.

The pilot trial

The pilot trial was a single blind randomised control trial testing v-neST on 30 people with psychosis with poor motivation and loss of pleasure of daily activities.


Assessments were carried out at the outset and three months post-trial. Secondary outcomes were increase in pleasure and motivation and enhanced functioning.


They study aims were to see if:


  • We could recruit enough eligible people;

  • People would adhere to the treatment regiment;

  • People would stay in trial.

Feasibility and acceptability outcomes

Then we evaluated acceptability through qualitative interviews asking for feedback.


The outcomes were:


  • We recruited to our target;

  • 100% of the recruits completed the baseline research;

  • We only lost 4 at the follow-up stage so couldn’t complete the three-month assessment for those individuals;

  • We monitored two serious adverse events but none of those were connected to the study;

  • An average of 9.7 session sessions were attended by the group.

Acceptability interview feedback

After completed the therapy, we interviewed participants and recorded interviews to analyse the results qualitatively. This is an important step to make changes to the therapy and the research procedures.


From these interviews, the following areas emerged:


  • Positive experience with therapy goals;

  • The impact of the pandemic;

  • Whether the participants found the symptoms disabling;

  • The relevance of VR;

  • Feedback on therapy procedures;

  • Suggestion for improvements.

Dissemination

This is a pilot trial not powered to assess the efficacy of an intervention. However, it is good practice to estimate the effects of an intervention to see if they are going in the expected direction.


We can assess effects using standardised co-efficients so that they can be compared across outcomes and with other interventions.


We don’t just measure effect size but the likely range of an effect. For example, for the primary outcome of this study, personal goals attainment, there is a wide range indicating that improvement in personal goals is likely.


All other measures assessed problems in motivation or functioning. So negative results are an indication of improvement as it is a reduction in problems. Best practice recommends the results be available to the wider scientific community and general public.


Summary


  • Pilot trials

    These are important to assess the feasibility and acceptability of an intervention.

  • Research outcomes

    Pilot trials can test the procedure, recruitment and study design but not efficacy.

  • Improvements

    Pilots can provide ideas for improving research procedures and proposed therapy.

  • Results

    Researchers should have clear criteria for pilots. Once satisfied, they should move on to an efficacy trial.


Avatar therapy for distressing voices



This case study looks at the efficacy of avatar therapy to reduce anxiety and enhance confidence in people with psychosis suffering from distressing voices.


In this section, we’re focusing on:


What is Avatar therapy?

Avatar therapy is designed for people who experience distressing voices in the context of psychosis. In this therapy, the person is supported to create an avatar who embodies the main distressing voice. They can customise how the avatar looks and sounds. They engage in series of face-to-face dialogues with the avatar facilitated by a therapist using voice-conversion technology.


This therapy aims to reduce the anxiety and distress associated with hearing voices and increase feelings of power, control and confidence.

Avatar trial

The trial was developed on laptop screens but there is ongoing intern work looking at the impact of conducting the therapy in fully immersive VR environments.


The intervention was first developed in 2013. At this time, it established proof of concept for the method of speaking with digital avatars.


As a pilot study with only 26 participants, the first study was not designed to address questions of efficiency. However, validated measures were collected and the research identified encouraging signals for the therapy to be helpful for people who experience distressing voices.


The research then evolved into two randomised control trials (RCTs). At the first RCT called the Avatar 1 trial, 150 people were recruited and randomised to receive either avatar therapy or an active control condition called supportive counselling. Assessments were conduct at baseline, 12 weeks and 24 weeks.

Efficacy of Avatar therapy

The primary outcome was a reduction in voice-related distress at the therapy follow-up session at 12 weeks.


The key finding from the Avatar 1 trial was the therapy demonstrated a significant reduction in voice severity and distress at the primary time point compared to the control group.


The Avatar 1 trial had:

  • Been undertaken in only a single NHS setting with a small, experienced group of therapists
  • Suggested ways the therapy could be improved

So, the next step was a multi-centred randomised control trial called the Avatar 2 trial. This aimed to optimise therapy delivery by comparing two versions of the therapy: a brief and an extended version.


The main research question centred on testing the effectiveness and cost-effectiveness of the two versions of Avatar therapy compared to standard care.


Importantly the trial tested effectiveness when the intervention is delivered across geographically and demographically diverse settings. This increases real world relevance of findings.


Data collection of the Avatar 2 trial has been completed but the results cannot be referenced until published in a journal. During the Avatar 2 trial, it was identified by the National Institute for Health and Care Excellence (NICE) Early Value Assessments as a promising digital technology.

Potential next steps

The next steps will focus on the deployment of Avatar 2 within the NHS to gain real-world evidence.


Firstly, clinicians in routine NHS care settings would need to be trained, and it would be part of the therapy offer to service users.


Longer term follow-up data ideally over a 12-month period is needed on clinical and costs effectiveness at baseline, 12 months and 24 months.


This offer is not part of a randomised control trial but an open choice for people receiving therapy for distressing voices. The feedback could be compared to the experiences of those receiving standard therapy.


If an external control comparison was made, it could look at:

  • Whether Avatar therapy is effective and cost effective when delivered in routine care
  • The main barriers and facilitators across diverse routine care settings

The results could include:

  • Quantitative data such as uptake
  • Qualitative data such as interviews across all stakeholders


Summary


  • Use of Avatars

    Avatars can be used by mental health patients to embody distressing voices.

  • Pilot study

    In 2013, a proof of concept for the method was developed. Then followed a pilot study. Validated measures were collected and the research identified encouraging signals.

  • Randomised Control Trials

    Two RCTs were then carried out. Assessments were conduct at baseline, 12 weeks and 24 weeks.

  • Findings

    Findings from the Avatar 1 RCT showed the therapy demonstrated a significant reduction in voice severity and distress at the primary time point compared to the control group. Data collection of the Avatar 2 trial has been completed but the results have not been published yet.


Got questions, comments or feedback?Get in touch with the teamhin.mindset@nhs.net


King's College London logo

Image

Health Innovation Network South London


Modules 12 – 20 quiz


Back to Module 19: Dissemination