Ad description
A website for health coaching provider The Chrysalis Effect, www.thechrysaliseffect.co.uk, seen on 23 July 2022, featured a page titled “Recovery Programme” with a header that stated “SUPPORTED RECOVERY PROGRAMME”. Text below that stated “A Comprehensive Online Recovery Programme […] with the personal touch to support you every step of the way”.
A video at the top of the page featured the founder of The Chrysalis Effect talking about their experiences with myalgic encephalomyelitis (ME), also known as Chronic Fatigue Syndrome (CFS), before detailing the specifics of The Chrysalis Effect programme, “These sessions will help you get underneath the symptoms to understand your personal triggers, and the underlying causes … you can choose from two recovery pathways. You can work through the programme with the support of The Chrysalis Effect team and community; or you can ask for referral to an accredited The Chrysalis Effect practitioner who can offer more one-to-one personal support, and tailor the programme specifically to your needs […] me and many members of The Chrysalis Effect team have either recovered or have supported a person through their recovery […] we’re passionate about recovery”. They stated that members of the programme community had “fully recovered”, while others were “working on their recovery”. A caption alongside the video stated “Hear our Founder’s story and the methods shared in the programme that helped her recover”.
Text further down the page detailed aspects of the programme and stated “One to One Support. The hand picked Independent Practitioners in our directory and listings have a broad range of modalities and have undergone either foundation or specialist accredited training. They specialise in dealing with M.E, CFS and Fibromyalgia recovery and work as a multi-disciplinary team ensuring that you have the right support at each phase of recovery”.
Issue
The complainants, who included the ME Association, challenged whether the efficacy claims that The Chrysalis Effect programme could aid in ME/CFS recovery were misleading.
Response
The Chrysalis Effect Ltd explained that they offered an online “Health Coaching Programme” that supported patients through a pathway, and they did not make claims to treat ME/CFS. Their programme, the Chrysalis Effect, delivered a specialist service for the National Health Service (NHS), supporting people who had been diagnosed with ME/CFS through their recovery. They said their founder had fully recovered from the condition, as had team members, their practitioner team, and a number of clients and patients who had used their service. They said the word “recovery”, as used in the ad, was now central to NHS services and pathways, and gave several examples of trusts using the term in relation to ME/CFS. They said the NHS had recognised that the service offered by the NHS to ME/CFS patients was not fit for purpose and needed to change, which was evident in the NICE Guidelines, following the most recent review. The post-review Guidelines had stated that help from specialist services with multi-disciplinary teams could be sought, and their programme included input from accredited general practitioners (GPs), clinicians, occupational health therapists, physiotherapists, nutritional therapists and psychotherapists.
The Chrysalis Effect said one of the challenges with recovery from ME/CFS was the absence of a definitive medical test that could diagnose the condition. As a result, diagnosis occurred through symptomology – a process of elimination that required referrals to, among others, rheumatology, gastroenterology, cardiology and neurology specialists. There was therefore no definitive, widely available scientific test to confirm recovery from the symptoms of ME/CFS. However, they said recovery from ME/CFS was possible. They explained that recovery required a trauma-informed bio-psycho-social approach, and they had been delivering that approach through a number of NHS pilots that had since been extended to further NHS cohorts. Their approach had been independently evaluated by one UK university, and was in the process of being evaluated by an academic at another UK university. They provided an article from a peer-reviewed journal that published the outcomes of the former, and a 2014 NHS report on the efficacy of health coaching.
The Chrysalis Effect said their recovery pathway was measured using quantitative evidence, gathered from symptom impact questionnaires (SIQs) which were self-completed by patients every three months. The questionnaires measured the impact of patients’ ME/CFS symptoms on energy and pain levels, sleep quality, mood, anxiety, depression, cognitive function, balance, sensitivity to noise and odours, and the ability to carry out daily living and personal care activities. Further evidence was gathered through an online forum, monthly video calls and interactive presentations, and online health profile reviews. They provided an example SIQ, completed SIQs from individuals who had used the programme, and information and SIQs from NHS pilots of the programme. Additionally, they provided a questionnaire completed by a participant in an NHS pilot, and testimonials from people who had used their programme.
The Chrysalis Effect said there were two models of healthcare - “acute disease” and “bio-psycho-social”; their programme followed the latter. They explained that the bio-psycho-social model helped primary care doctors to understand the interaction between biological and psychosocial elements of an illness, in order to improve the relationship between clinicians and patients in multidisciplinary approaches to patient care. They said the bio-psycho-social model could improve clinical outcomes for chronic diseases, but was difficult to implement, with a biomedical approach being dominant. They provided a paper that criticised the biomedical approach and proposed the bio-psycho-social model, and said that an area of importance to understanding of ME/CFS was adverse childhood experiences (ACE) and trauma – both of which informed the advertised programme. They had observed that Chrysalis Effect patients reported high levels of ACE. They said evidence from Chrysalis Effect pilots was being collated and submitted for a peer reviewed study into the link between ACE and ME/CFS and fibromyalgia and the role the bio-psycho-social approach could have. Funding was currently being sought for that study. They provided a press release from the World Health Organisation on ACE, a spreadsheet showing the percentage of Chrysalis Effect participants who had experienced ACE, a study on the link between psychological stress in childhood and adult disease and disability, and a video presentation and submission from a researcher with a PhD in Health Psychology who had used the programme.
The researcher said they had fully recovered from ME/CFS through The Chrysalis Effect’s programme. They said The Chrysalis Effect lent itself to assessment through Complex Service Evaluation, rather than clinical trials. The work carried out by The Chrysalis Effect was complex and multifaceted, and did not have one single variable that indicated its effectiveness. Instead, the programme had multiple independent variables that influenced the final outcome, recovery. They explained there was no common definition of the term “recovery” in the context of ME/CFS, but some studies in the area suggested it could be defined in terms of a patient’s perception and assessment of their return to health, like the SIQs provided by The Chrysalis Effect. They provided a systematic review in support of their comments.
Assessment
Upheld
The ASA considered that consumers would understand claims such as “Recovery Programme”, “SUPPORTED RECOVERY PROGRAMME”, “A Comprehensive Online Recovery Programme”, and “[Our practitioners] specialise in dealing with M.E, CFS and Fibromyalgia recovery and work as a multi-disciplinary team ensuring that you have the right support at each phase of recovery” on the website; and the claims “you can choose from two recovery pathways”, and “we’re passionate about recovery” in the video to mean that The Chrysalis Effect’s programme could be, and had been, successfully used to aid ME/CFS recovery. We considered, in addition, the claims “me and many members of The Chrysalis Effect team have either recovered or have supported a person through their recovery and the testimonials from members who said they had “fully recovered” in the embedded video to mean the programme had been successfully used to facilitate full clinical recovery from ME/CFS. The CAP Code required that objective claims like those must be backed by evidence, if relevant, consisting of trials conducted on people. Substantiation would be assessed on the basis of the available scientific knowledge. We considered that meant The Chrysalis Effect should hold scientific evidence in support of the claims that their programme could aid the recovery of ME/CFS.
We assessed the evidence provided. One piece, a pilot study in a peer-reviewed journal, examined the application of The Chrysalis Effect’s programme to people with ME/CFS. Other evidence focused on the credentials of The Chrysalis Effect and its practitioners, the background to health coaching, documents used by The Chrysalis Effect in the course of its programme, third-party guidance from NICE and the NHS and a systematic review on the literature of paediatric recovery from ME/CFS. While that evidence reflected positively on the programme and its practitioners, it was not focused on the application of The Chrysalis Effect to people with ME/CFS. It was therefore not applicable to the claims under investigation. We assessed the client testimonials and self-completed questionnaire from a participant in one of The Chrysalis Effect’s NHS pilots. However, the self-reported nature of that evidence undermined its objectivity and reliability, and it was therefore not adequate substantiation for the claims.
We reviewed the pilot study published in a peer-reviewed journal that related to the application of The Chrysalis Effect’s programme to people with ME/CFS.
The study was completed by 18 participants over a three-month period – 12 participants in a non-individualised internet programme, and the remaining six participants in an individualised internet programme and video consultation. At the end of the respective three-month programmes, the participants self-completed questionnaires related to their symptoms, mental health, diet and lifestyle. Both groups recorded improvements in each category, with the individualised group seeing greater improvements in diet and mental health than the non-individualised group. The study stated that it had been difficult to draw meaningful conclusions from the data collected for a number of reasons – small sample size, short duration of the study, selection bias resulting in participants who were not representative of the general population, no control group being used and group allocation having not been randomised. We also noted the participants in the study had not fully recovered from ME/CFS.
While we understood that further study in support of The Chrysalis Effect was ongoing, we had not seen sufficiently robust evidence to substantiate claims currently made about the efficacy of the programme in aiding ME/CFS recovery, or that full recovery from ME/CFS using the programme had been achieved. We therefore concluded the ad was likely to mislead.
The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), and 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in the form complained of. We told The Chrysalis Effect Ltd to ensure they did not make claims that their programme could aid in ME/CFS recovery, or full clinical recovery from ME/CFS, unless they held sufficient evidence to support the claims.
