SilverCloud Target Trials

About the SilverCloud Target Trials

Our aim is to know how internet-delivered cognitive behavioural therapy (iCBT) is used and how well it works in England’s healthcare system. Also, to see if iCBT offers value for money and how well it works for different groups of people. 

The SilverCloud Target Trials are evaluating the SilverCloud by Amwell iCBT programmes:

• Space from Depression for people with depression

• Space from Anxiety for people with generalised or unspecified anxiety disorder

Background

Cognitive behavioural therapy (CBT) can help people manage their problems by changing the way they think and behave. NHS Talking Therapies for anxiety and depression services offer low-intensity CBT to people with less severe depression or anxiety disorders. Low-intensity CBT is given to individuals, groups, or as iCBT. But we don’t know how well different ways of giving CBT works for different people.

Randomised controlled trials are often used for comparing different treatments. Randomised refers to allocating treatment to each person at random. This helps provide the best evidence of how well different treatments work. But many people who have therapy in ‘real-world’ healthcare settings do not take part in trials. This limits what trials can tell us about normal care in England’s healthcare system.  

Instead, real-world data (RWD) studies do not control the treatments used. They can also use data already collected as part of routine healthcare. But not allocating treatments at random can cause problems. For example, it can be harder to know if any benefits are due to treatment or patient differences. There are methods to aid real-world data studies avoid these problems, which we will be using in our project.  

Patient and Public Involvement (PPI)

We are working with the McPin Foundation, a mental health research charity. Together we are forming a diverse lived experience advisory panel. Our advisory panel will help develop the study design and research questions. They will also develop ways to explain our study design and results. Advisory panel members will receive training and support. 

Real-World Data (RWD) Study

We will compare iCBT to individual or group low-intensity CBT and will conduct 'target trials' which resemble the good aspects of trials. We will also study if treatment outcomes are impacted by differences between people, for example, based on ethnicity or social deprivation. 

Our Real-World Data (RWD) Study will use data normally collected within England’s healthcare system. We will use data from NHS Talking Therapies for anxiety and depression services. Other data will come from hospitals, pharmacies and other mental health services. 

Implementation Research

We will involve healthcare staff and patients to understand challenges to giving iCBT and iCBT use. 

Work-Packages

To achieve our project aim we have seven work-packages:

1. Project Oversight

2. Patient and Public Involvement (PPI)

3. Real-World Data (RWD) Preparation 

4. Real-World Data (RWD) Study

5. Implementation Research

6. Commercialisation

7. Dissemination including adoption

Funding

The SilverCloud Target Trials project is funded by the NIHR i4i & OLS Real World Evidence Programme. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.