Oct 02

Needed Better Review Process for Mental Health Technologies

Increasingly Apps and online-delivered treatments are a novel and popular way to manage mental health disorders. However, only a small minority have gone through any kind of testing to prove they work. Regulators of drug treatments take the opposite approach and require rigorous testing before a drug hits the market. Should companies that sell online psychological treatments be subjected to the same level of scientific scrutiny as drug treatments?

Drug development is an expensive business. Drugs typically take 12 years from the initial discovery stage to reach the market and only 1 in 5,000 make it. According to the Association of the British Pharmaceutical Industry, the cost to get a drug to market is estimated to be £1.15bn.  The FDA requires every company to strictly follow the process below.

FDA – 8 Phases for Developing a Drug
Pre-Discovery Researchers work on understanding a particular disease
Drug Discovery Scientists identify a target or way to combat the disease
Optimising the lead Can take 2 years & costs $10m (£7.1m)
Pre-clinical testing Mandatory studies in animals to determine toxicity
Phase 1 Clinical Trials Done in healthy human volunteers to see if the drug is safe
Phase 2 Clinical Trials Tested on small numbers of patients to see if it’s effective
Phase 3 Clinical Trials Carried out on 1,000 or more patients to provide evidence of effectiveness
Phase 4 Clinical Trials Evaluate long-term effects of new drugs  over a lengthy period for a greater number of patients

A similar approval process does not exist for developing online psychological treatments that are marketed as therapies for the same diseases that drugs treat. In effect, anyone can develop a mental health app and apply to the google or android store to host it. Makers of mental health apps don’t have to show that the app works or that it’s safe. Furthermore, Apple iTunes and Android Google decide, which online health apps it will host?  How did that happen?  Google and Apple’s  star ratings or number of downloads do not correlate well with quality.

However, regulatory bodies and stakeholders are starting to recognise this issue. In October 2015, NHS Choices was forced to take down their recommended list of 27 online mental health apps. Only 4/27 apps were able to demonstrate some type of effectiveness and only two of those four used validated psychometrics ie the GAD7 and PHQ9, to assess clinical performance.

The number of online psychological treatments has increased at an exponential rate over the last 5 years. Just type in “mental health” in the google or the android app store and trust me you will be scrolling for quite some time.

Medical App BreakdownA recent systematic review  on mental health apps revealed a complete lack of trial-based evidence for the majority of mental health apps currently available. The researchers concluded that, “randomized controlled trials are required to validate future MHapps and the principles upon which they are designed.”

Intervention vs treatment hierarchy

Hierarchy of evidence for questions about the effectiveness of an intervention or treatment

The randomised controlled trial (RCT) is considered the gold standard for evaluating the effectiveness of therapeutic interventions. The RCT provides the most reliable evidence on the effectiveness of an intervention, because it minimises the risk of outside factors skewing the results. Because of this, the findings generated by RCTs are likely to be closer to the true effect than the findings generated by other research methods. The problem is – RCTs are very expensive to do and take a long time.

Cognitive Behavioural Therapy (CBT) is recommended by NICE guidelines for common mental health disorders as a first line treatment in:

  • Depression
  • Panic
  • Obsessive Compulsive Disorder
  • Generalized Anxiety Disorder
  • Specific Phobia
  • Social Phobia
  • Insomnia
  • Alcohol/Substance misuse

CBT has the largest evidence base for the treatment of various mental disorders. Therefore, it’s no surprise that CBT is the preferred method used in most mental health apps and online programs. The components of CBT have largely remained unchanged since pioneered by Dr. Aaron T. Beck in the 1960s, however the technology to deliver these techniques is moving at a much faster pace.

How do we know that delivering CBT using an online technology works? The good news is that a lot of supporting evidence exists for online programs. The bad news is that the evidence is scarce for apps. Computerized CBT for some online programs is proven to be clinically effective by numerous, well-conducted RCTs. It cuts cost by allowing clinicians to manage six times the amount of patients in an hour. Computerised CBT is a practical alternative for people who live in remote areas or find traditional face-to-face care stigmatizing. A great benefit of computerized CBT is that it is widely accessible on all compatible laptops, cellular phones and PCs.

Developing the technology to deliver online treatments is expensive and can cost millions. Not only is it expensive to develop, but it is also very costly to maintain. The technology has to be of a standard that is current and up-to-date and compares well with other consumer-engaged technologies. Otherwise both buyers and users of the technology will make assumptions based on look and feel. Companies who market better usually sell better. The “shininess factor” wins a lot of the time. Clearly we like to think that evidence is more important that the look and feel of a technology but that’s not what we see.

Our company commercialises IP developed by experts and researchers affiliated with universities. We have sixteen RCTs to support our range of programs. The participants in our trials emulate real-world primary care populations. Below is a diagram of our process for developing computerised programs.

process for developmentIn the computerised field for mental health treatments, Professor Issac Marks from Imperial College in the University of London is considered to be the first person to have developed a computerised cognitive behavioural therapy program.

While delivering CBT to his patients in the ’90s, Professor Marks had the idea to embed his repetitive explanations of CBT anxiety treatments into one computer program. Out of this, FearFighter was born. CCBT Ltd was created soon after to commercialise Fearfighter. Since Professor Marks is a world renowned psychiatrist and researcher, he did what any sensible researcher would do: he tested FearFighter in several RCTs to see if it truly worked. Results showed that it did. Marks also showed that clinicians who recommended Fearfighter to patients were able to reduce their time per patient by 73% without losing efficacy. Because of Professor Mark’s work, The National Institute for Health and Care Excellence (NICE) endorsed FearFighter as an effective standard treatment for panic and phobia. It is still the only computerised CBT program to have been endorsed by NICE.

The overwhelming majority of health professionals (79%) agree that pharmaceutical companies should be legally obliged to test new medicines using standardized methods that are the most predictive of safety for humans. Would those health professionals then agree that online psychological therapies and apps be held to the same standard?

Currently it is the responsibility of the company seeking to market a drug to test it and submit evidence for its safety and effectiveness. The same rules do not apply to companies that develop online psychological treatments and apps. Should those companies at least be mandated to show their apps and online programs work demonstrated by a randomised controlled trial. Clearly our company thinks they should. Others might argue that making a company do an RCT will stifle innovation, which is probably true. On the other hand RCTs will guarantee safer treatments and ones that are known to be effective.

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