IAPT Has Been A Law Unto Itself and is Rightfully Being Ignored by NICE

The National Institute for Health and Clinical Excellence (NICE)  can only base its treatment recommendations on studies that have a rigorous methodology. In generating the proposed recommendations on the treatment of depression &source=web&cd=&ved=2ahUKEwic8KOfmcD1AhVOasAKHVt8C_EQFnoECAcQAQ&url=https%3A%2F%2Fwww.nice.org.uk%2Fguidance%2Findevelopment%2Fgid-cgwave0725&usg=AOvVaw01CPXDGEYzB5NZCOPcgTFr NICE has ignored all studies that  emanate from the Improving Access to Psychological Therapies (IAPT). Yet the lead organisation for cognitive behaviour therapy, the British Association for Behavioural and Cognitive Psychotherapy (BABCP) BABCP response – NICE consultation draft https://www.google.co.uk/urlsa=t&rct=j&q=&esrc=s has protested vehemently about this. But applying the ‘Psychotherapy outcome study methodology rating form’ developed by Ost (2008) OST the original randomised controlled trials of CBT for depression and anxiety disorders had a mean score  of 27.8, (SD 4.2). Applying the scale to studies by IAPT related personnel, they struggle to score into double figures – a fate shared by studies of low intensity CBT.  To put these scores in context, Ost (2008) dx.doi.org/10.1016/j.brat.2007.12.005 found the total mean score for ACT was 18.1 (SD 5.0) and for DBT 19.4 (SD 3.9). He considered the scores for ACT and BDBT too low, for them to be regarded as Evidence Supported Treatments (ESTs). How much less of an EST then are the IAPT interventions? BABCP defends itself by saying the IAPT studies need to be evaluated by some other metric, but don’t specify which. This sounds suspiciously like the defending of a family member, rather than being data driven.

It should be noted that IAPT does not measure either adherence  (item 15 on the rating form) nor competence (item 16 on the rating scale). Thus there is no assurance of treatment integrity in IAPT. IAPT clinicians have been a law unto themselves. NICE therefore cannot be sure that IAPT’s alleged treatment interventions were delivered.

The studies by IAPT related personnel fail abysmally on almost every index of reliable methodology. Running through the rating form: IAPT therapists do not make diagnoses, making for ‘0’ scores for items 1-6, similarly ‘0s’ would be awarded for no blind evaluators (item 7), no assessor training (item8), no random, assignment to treatments (item 9), no control groups (item 10), treatment as usual (item 11), no power analysis (item 12), only pre and post assessment points  (item 12), effects of therapist were not assessed, nor level of training  [items 14 & 15generously a score of 1 could be awarded on both these items, no control of concomitants (item 18), no intention to treat analyses (item 19), statistical analysis confined to completes (item 20),  no evidence of real world clinical significance (item 21 but a case could be made for awarding a 1 score, no equality of therapy hours because no comparison condition (item 22).  

The low intensity rcts similarly rate very poorly on the rating form. Studies of these cheap offerings rely on establishing statistically significant differences with a comparison group. Never stopping to assess whether any found difference is clinically  meaningful. Any differences do not pass the ‘Does it matter? test, or the ‘So what? test or the ‘Why should anyone care?’ test. In none of the studies have clients been asked independently post treatment  ‘are you back to your usual self, now?’ Importantly if they reply ‘yes’,  then asking ‘for how long have you been back to your usual self?. Studies of the natural history of anxiety disorders have utilised a period of 8 weeks free of  meeting diagnostic criteria, to define recovery, Bruce et al (2005)] The absence of data on the proportion of clients returned to their normal and enduring functioning  by these ‘cost-saving’ interventions, means that prospective clients cannot make an informed choice about engaging in such treatments. NICE needs to proceed more cautiously in recommending low intensity CBT.

 

Dr Mike Scott

The Bell Tolls for IAPT if NICE Has Its’ Way

according to the BABCP’s submission BABCP response – NICE consultation draft  to the National Institute for Health and Clinical Excellence (NICE ). Implementation of the latter’s proposed guidance would mark the end of the Improving Access to Psychological Therapies (IAPT) service. 

Interestingly BABCP recommend that assessment should begin with a reliable diagnostic interview and acknowledges that IAPT’s Psychological Wellbeing Practitioners (PWPs) are not equipped to do this. Further BABCP recommend that outcomes should be assessed from the client’s perspective but do not specify how. Ironically some of BABCP’s own recommendations undermine the functioning of its over-induIged prodigy, IAPT. BABCP are alarmed that the proposed guidance would, in their view, herald the end of stepped-care.

BABCP are aghast that NICE have not included studies by IAPT related personnel in determining the way forward. In defence of IAPT, BABCP cite the Wakefield et al(2021) https://doi.org/10.1111/bjc.12259 study published in the British Journal of Clinical Psychology but fail to mention my rebuttal paper Scott(2021) https://doi.org/10.1111/bjc.12264 published in the same issue of the Journal. Quite simply NICE does not consider studies that are based on agencies marking their own homework as having any credence. This is thoroughly reasonable.

The BABCP have rightly pointed out to NICE that in recommending group interventions as the starting point for offering clients help, they have not properly looked at the context of the group studies. As I pointed out in my submission to NICE COMMENTS ON PROPOSED GUIDANCE (and simultaneously submitting via BABCP as a stakeholder), there are considerable hurdles in engaging clients in group therapy, see Scott and Stradling (1990)Group cognitive therapy for depression produces clinically significant reliable change in community-based settings Behavioural Psychotherapy, 18: 1-19 and Simply Effective Group Cognitive Behaviour Therapy Scott (2011) https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiph5Hlvbb1AhWKX8AKHRSJDZ0QFnoECAUQAQ&url=https%3A%2F%2Fwww.amazon.co.uk%2FSimply-Effective-Cognitive-Behaviour-Therapy%2Fdp%2F0415573424&usg=AOvVaw0nam02gszlQ0HqCktSCB0s. 

In fairness, I think Prof Shirley Reynolds from BABCP has done a great job in reviewing the extensive documentation provided by NICE and collating the individual submissions, all within a very brief period of time. I understand from her that these matters will feature in the next issue of CBT Today and whilst I was happy to have my name noted as having submitted, there are important aspects of the submission on which I wish to dissent.

NICE make its’ formal recommendations in May, interesting times

 

Dr Mike Scott

More Treatment But No Less Disorder: What Is Going on Here?

 

a soon to be published study by Ormel et al https://doi.org/10.1016/j.cpr.2021.102111 highlights the increased access to psychological therapies but notes that the population prevalence of disorder has not decreased. The authors term this the ‘treatment-prevalence paradox’ (TPP) and although their focus was on depression, it likely applies to all the common mental disorders. They consider that the most likely explanations are that:

(a) the published literature overestimates short- and long-term treatment efficacy,

(b) treatments are considerably less effective as deployed in “real world” settings, and

(c) treatment impact differs substantially for chronic-recurrent cases relative to non-recurrent cases.

 

Efficacious treatments are it seems, likely lost in a fundamentalist translation that preserves the reputation of service providers. Independent corroborative evidence of effectiveness is non-existent.

In the event of the statistically likely, ‘real world’ failure of a psychological treatment how should a clinician respond? With dismay, if he/she is an IAPT therapist enjoined to demonstrate a 50% recovery rate. The pressure to manipulate test results will be great, ‘on item x did you really mean…’ . The therapist might protest that any one case is ‘complex’, but such a claim is likely to be given short shrift, with repeated vocalisations.  A suspicion of ‘incompetence’ lurks, which may be at least temporarily assuaged, by agreeing to go for further training. But the dice are it seems loaded in favour of burnout, this New Year.

There is no IAPT protocol for treatment failures.  In a spirit of apparent openness A GP may be invited to re-refer  if ‘appropriate’. The latter might just do this if badgered by the patient at some future point. But given that the same assessment and treatment procedures will be in place, another spin around the revolving door is the most likely outcome. IAPT in effect puts most client’s in a waste-paper bin, some are recycled to no avail.

 

The TPP will continue until service providers enable therapists to ask ‘who, needs what treatment?’. Following the mnemonic PICOT, the ‘who’ is determined by  asking which population (P) is this person representative of? There are ‘gold standard’ semi-structured diagnostic interviews to clarify the best fit between a person and a patient population. The use of short-cuts (heuristics) such as solely relying on a test result or highlighting a particular symptom of a disorder, leads to mis-diagnosis and an inappropriate intervention – the I of PICOT. The I should follow  a published treatment manual that specifies the treatment targets and matching treatment strategies for the particular identified disorder. But a treatment protocol lacks credibility if its efficacy was not assessed by comparison (the C) with an active control condition. Similarly outcome studies (the O) lack credibility if they did not involve blind independent assessors. T refers to the duration of follow-up, all conditions wax and wane, so assessment at any one point can simply be ‘ flash in the pan’, enduring change is the mark of recovery.

Service providers, such as IAPT should ensure that they make therapists aware of  the quality of the foundation for the chosen intervention, but this is rather like getting turkey’s to vote for Christmas! Courses run by Academic Institutions for IAPT dare not risk biting the hand that pays them. 

 

Dr Mike Scott

Cost Of Improving Access to Psychological Therapies (IAPT) Last Year, Over £1bn, But No Independent Corroboration of Effectiveness

A contemporary of Mark Zuckerberg has been arrested because there was no independent evidence that her scanners could furnish 100’s of blood results from just a few drops. There is it seems more accountability in Silicon Valley  than in the UK mental health services. The IAPT (Improving Access to Psychological Therapies) target for 2021 was 1.5 million clients at a cost of £680 per client [data from Clark (2018) https://doi.org/10.1146/annurev-clinpsy-050817-084833] the anticipated cost of the service was £1.02 billion. Where is the evidence that this was value for money?

 Recently I saw a lady who was suffering from a DSM-5 defined phobia about travelling as a passenger in a car, as assessed with a ‘gold standard’ diagnostic interview. But this was not targetted by IAPT, the Psychological Wellbeing Practitioner wrote to the GP thus  ‘completed an assessment .. presenting problems identified  (please note : this is not a formal diagnosis): GAD and depression. .. waiting list Step 2 CBT Guided Self-Help PHQ9 11 GAD7 8′. This lady was not suffering from GAD or depression and appropriate treatment was not flagged up. There is no evidence that GSH is an evidence based treatment for a specific phobia. IAPT uses diagnostic terms to confer legitimacy on its’ endeavours but then seeks to avoid being held accountable by saying that it does not make reliable diagnoses! With IAPT the NHS has bought a pig in a poke.

Dr Mike Scott

IAPT and The Rogue Driving Instructor

Imagine the would-be driving instructor for your son/daughter, has on public record, that for every person attending 2 or more lessons there is one person who attends just once. Warning lights would flash . But the latest IAPT data, for September last, https://digital.nhs.uk/data-and-information/publications/statistical/psychological-therapies-report-on-the-use-of-iapt-services/september-2021-final-including-reports-on-the-iapt-pilots-and-quarter-2-data-2021-22 show just such poor engagement, with 39,734 having only one treatment appointment and 56,972 having two or more treatment sessions. Further, just as many people fail to follow up their referral (self or GP) , 43,258 as have one or two or more treatment sessions. This suggests that IAPT is not high in the public credibility stakes. The driving instructor may claim a 50% pass (recovery) rate but would you believe them without independent verification? IAPT’s self-proclamation of such a recovery rate lacks credibility.  

IAPT claims 7.9 sessions of treatment per referral, but can this be regarded as sufficiently potent when NICE recommended treatments are typically twice this length? On December 9th 2021 NHS Digital proclaimed that the ‘Improving Access to Psychological Therapies (IAPT) is run by the NHS in England and offers NICE-approved therapies for treating people with depression or anxiety’. Yet neither NICE nor IAPT have provided any evidence of treatment fidelity. Both display what the Chair of the Hillsborough Independent Panel has termed ‘the patronising disposition of unaccountable power’ [ ‘Justice for Christ’s Sake’ by James Jones SPCK (2021)]. The Panel also highlighted 3 necessities for further public enquiries, empathy, equality and candour. It would be empathetic to ask  IAPT clients ‘are you back to your old self with the treatment you have received or alternatively are you back to your best?’. Equality  would mean giving precedence to the client’s definition of their situation, and not an organisational device {PHQ9 and GAD7) administered in such a way as to protect the reputation of the Service. Candour would be allowing IAPT therapists to tell it as it is, no longer too fearful to speak out or having to use such measured tones that the central meaning of what they have to say is lost. 

Dr Mike Scott

 

People Cannot Benefit from a Treatment To Which They Have Not Been Exposed – The Undermining of IAPT

The Improving Access to Psychological Therapies (IAPT) Service does not assess treatment fidelity. Thus, there can be no certainty that clients receive an evidence-based treatment treatment.  IAPT therapies are not EBTs. Despite this, the major funder of IAPT training days SilverCloud, claims on its’ website ‘up to a 70% real-world recovery’ using its computer assisted products, for all common disorders except PTSD and OCD!  The Advertising Standards Authority need to look at this, the ASA has a complaints form that can be completed online. SilverCloud’s UK address is Suite 1350, Kemp House, 152 City Road, London, EC1V 2NX., My own study of 90 IAPT cases suggests just a 10% recovery rate, Scott (2018) https://doi.org/10.1177%2F1359105318755264).

IAPT have produced no evidence that its’ therapists using SilverCloud make any added difference to their clients over and above that of those who didn’t use it. see SilverClouds Space for Depression programme   NICE Guidance ‘Space from depression for treating adults with depression’ Medtech innovation briefing published May 7th 2020. Strangely the NICE IAPT Expert Panel concluded that the case for adoption is ‘partially supported’ despite in the body of report noting lower depression scores, at the end of treatment for the clients of therapists who did not use the computer assisted CBT. An example of spin and conflict of interest.

 

The SiverCloud website cites 10 references appearing in peer-reviewed journals to support its work.  But none of the studies cited by SilverCloud involve blind independent assessors of outcome using a ‘gold-standard’ diagnostic interview. In the cited review study by Wright et al (2019) Wright JH, Owen JJ, Richards D, et al. Computer-assisted cognitive-behavior therapy for depression: a systematic review and meta-analysis. J Clin Psychiatry. 2019;80(2):18r12188 the third author is employed by SilverCloud.

 ‘Real-world’ recovery represents a change that a client would care about, such as no longer suffering from the disorder that they were suffering from before treatment or a return to best functioning. In a footnote SilverCloud defines recovery as ‘Moving from clinical caseness to non-caseness, i.e. lowering the score on PHQ-9 and GAD-7 from above the clinical threshold to below the threshold’. Such changes are meaningless to clients they are not ‘real-world’.

Here is what one client told  me:

‘I found Silvercloud ineffective, generic and not tailored to my personal situation. It wasn’t engaging or helpful and as such I didn’t engage with the website very much. Consequently, the following weekly call with the IAPT therapist  were sometimes made difficult by the fact I hadn’t completed the same questionnaire as the week before or read through articles. I wanted to talk about my situation, my feelings and find out why I was feeling the way I was, but I felt I was just being led back to using the online SilverCloud resource.

‘It was in 2017 that my doctor suggested I try SilverCloud online CBT with telephone support and in September 2017, I started speaking to another IAPT counsellor. He seemed to be a very nice man. After a few weekly calls, he stated that he didn’t believe I was depressed and so he changed the original Silvercloud course I had started and reset it back to a new series of 6 sessions. The weekly calls lasted between 20 minutes to an hour depending on what we discussed, but always concluded with him asking me to log onto SilverCloud and work my way through the programme before our next call. After the requisite 6 sessions finished in February 2018, that was it! No answers, no tools to help me cope, just signed off, discharged, but told I had 12 month access to SilverCloud. I haven’t used the resource since’.

In general the claims of clinicians and supervisors with regards to treatment fidelity do not match those of independent blind-raters [ Waltman et al (2017)https://doi.org/10.1016/j.janxdis.2021.102407], there are vested interests at play.

The author knows of no study of low intensity CBT (guided self-help, group psychoeducation, computer assisted CBT) that has assessed treatment fidelity. Usage of a manual does not guarantee treatment fidelity. Approx. three quarters of IAPT clients receive low intensity intervention on entry to the Service [Davis et al (2020)https://doi.org/10.1136/ebmental-2019-300133].].

IAPT’s approach ostensibly depends on the results of randomised controlled trials of CBT, but a study of remission rates in CBT for anxiety disorders (including OCD and PTSD) Levy, Bryan and Tolin (2021) https://doi.org/10.1016/j.janxdis.2021.102407 showed that in half the studies (8 out of 17) there was a high risk of bias because of a failure to address treatment fidelity. Further in 7 of the 17 studies there was a high risk of bias because of the failure to use blind assessors. [A re-view of psychotherapy trial reports published in 6 top psychiatry journals in 2017 and 2018 revealed that only 59% of the included trials reported adequate blinding of outcome assessors Mataix-Cols et al (2021)]. https://jamanetwork.com/journals/jama/fullarticle/10.1001/jamapsychiatry.2021.1419?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jamapsychiatry.2021.1419].Thus, the research base that IAPT draws upon is far from rock solid.  The remission rate in rcts for anxiety disorders is approx. 50% [ Springer et al (2018) https://doi.org/10.1016/j.cpr.2018.03.002]and this is the ‘gold standard’. But IAPT claims comparable results despite a total disregard for blinding and treatment fidelity! The faked goods ought perhaps to be reported to Trading Standards as well as ASA, in lieu of any interest in the matter from the British Psychological Society (BPS) or the British Association for Behavioural and Cognitive Psychotherapy (BABCP)!

The real story of SilverCloud is that it provides morsels of CBT when what is really needed is a proper meal. It is insulting to clients to in effect say ‘let’s see how you get on with morsels and then we will see about a proper meal’.

 

Dr Mike Scott

New NICE Menu for Depression

The proposed Guidance, published last month, excludes consideration of assessment. Recommendations are  therefore built on sand. Depression can occur in a variety of contexts and alongside other disorders, NICE’s response is that it doesn’t matter so long as there is a high score on a depression psychometric test. The clinician, not the client holds the menu, the former takes them through the options in a set order. For ‘less severe’ depression group CBT is to be canvassed first with clients, next in line is group behavioural activation. Despite the fact that the latter group modality has not been assessed with blind independent assessors.

 

NICE advocates different pathways for ‘less’ and ‘more severe’ depression, advocating a cut-off of 16 on the PHQ-9. De facto the authors rubber-stamp the widely held practice, reflected in the Improving Access to Psychological Therapies (IAPT) Service, of routing high scorers on a depression psychometric test (e.g PHQ-9 score 10 or greater) to treatment for this condition. But patients with a wide range of disorders including, panic disorder, PTSD, obsessive compulsive disorder and adjustment disorder have elevated depression scores. Nevertheless, NICE signals a diversion along a depression pathway with one fork for ‘less severe’ and another for the ‘more severe’. Clinicians and clients are likely to be equally bemused by the ‘road signs’. The upshot is likely to be misguided treatment.NICE have invited the public to Comment on their intended guidance https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0725/consultation/html-content-3 on the treatment of depression. Commentary has to be submitted specifying the particular paragraph that any comment is about, so it is somewhat tedious, and you may well decide to write your Christmas cards instead. 

 

Generalising from Low Quality Studies

In assessing the outcome studies NICE do not take seriously the concept of minimally important difference (MID) i.e what change would a a patient see as the minimum requirement necessary for them to say treatment has made a real-world difference. There is no evidence that they would regard a change of score on a psychometric test as conferring a real-world difference. But they would recognise being back to their old self or best functioning and possibly no longer suffering from the disorder, so that loss of diagnostic status would be a reasonable proxy for a MID. However only a minority of studies furnish this data with the use of blind assessors. Inferences can therefore only be properly drawn from this sub-population of studies, which exclude the low intensity studies. As an exemplar see the comparison of group CBT and group behavioural activation at the end of this document.

 

Pseudo-preferences

 

Under the proposed Guidance client’s preferences are paramount.  If the client is judged as having ‘less severe’  depression and volunteers no treatment preference, they are to be taken through  a menu of options in a set order starting with first group cognitive behavioural therapy, second group behaviour activation, third individual CBT and on to the 11th option short-term psychodynamic therapy.  For ‘more severe’ depression top of the league is individual CBT plus antidepressants, in 2nd place individual CBT, and in 3rd place individual behavioural activation and in last and 10th place is group excercise. The ‘more severe’ route is more labour intensive and there is likely to be congestion as approximately half those entering IAPT have mean scores of 15 or more on the PHQ-9 [Saunders et al (2020) https://doi.org/10.1017/S1754470X20000173]. Unwittingly the Guidance spells the end of low intensity interventions because none of the top of the league options are low intensity! But 70% of clients entering the IAPT service are given a low intensity intervention first. However there is nothing to prevent a Service Provider declaring that ‘unfortunately none of the top of the league options are currently available’ and recourse has to be made to options in danger of relegation.

Psychometric Test Results Can only be Considered in Context

 

The NICE guidance assumes that psychometric test results speak for themselves but they are only meaningful when described in context. To my knowledge there is no study of the reliability of the PHQ-9 in UK routine mental health services compared to a ‘gold standard’ diagnostic interview. Rather data on the PHQ-9 has been extrapolated from from US studies of psychiatric outpatients, in a population with a high prevalence of depression, but not using a ‘gold standard’ diagnostic interview [The Prime MD was used instead, with insufficient distinction between this interview and the questions on the PHQ-9]. It is the author’s experience that in the UK the PHQ-9 gives a large number of false positives compared to a reliable diagnostic interview, such as the SCID.

 

The Need to Contextualise Outcome Studies

NICE has a ‘blind spot’ about context. In its’ analysis of outcome studies it lumps together ‘depression studies’ that were wholly reliant on self-report measures with those that included the results of a diagnostic interview as an outcome measure. Outcome is assessed in terms of statistical differences between either different modes of service delivery e.g stepped v non-stepped or between different treatments e.g CBT v waiting list. There was no attempt to try and discern what proportion of clients in each arm of a study would have regarded themselves as back to their normal selves or best functioning post treatment [ or in lieu of this, lost their diagnostic status] and the duration of those gains. Rather than patients being asked to cite preferences over treatments they largely have no knowledge of, they would be very interested as to the likelihood of treatment making a real-world difference to their lives i.e a difference that they would care about.

 The Need to Consider Effectiveness Studies Not Just Efficacy Studies

NICE’s failure to look at context is highlighted in the top league place it gives to group CBT for less severe depression. No mention that in our study [Scott and Stradling (1990)https://doi.org/10.1017/S014134730001795X ] of individual and group CBT for depression in Toxteth, Liverpool the invitation to group CBT went down like a ‘lead balloon’ and we had to change the protocol to include up to 3 individual sessions in the ‘group’ arm. Entry was determined by independent diagnostic interview, but mean entry Beck Depression scores were around 28, so the population was likely ‘more severe’ in NICE terms. NICE also fails to critically appraise the Group Behavioural Activation studies, having previously called for BA studies to include observer rated assessments. They may have also added the need for credible attention control comparisons. NICE is content with statistical sweeps at large data sets rather trying to discern what is happening at the coal face.

Ignoring the Pandemic

NICE puts group interventions as top of the league for less severe depression, but ignores the context of the pandemic, realistically how possible will it be two get 2 therapists together with 8 clients for 90 minutes a week for 8 weeks, all face to face. with masks? The logistics and effectiveness of conducting it online is a venture into the unknown. NICE appears to operate without contextualisation of findings.

 

Failing to Pay Attention to the Detail of Group Interventions

In 2019 Kellett et al published a paper in Behavior Therapy, 50 (2019) 864–885 the abstract advocates Group Behavioral Activation for depression as a front line treatment. The abstract also claims a moderate to large effect on depressive symptoms. NICE appears not to have read further than the abstract, but closer inspection reveals the conclusions are deeply flawed.

In passing the abstract mentions that the standardized mean difference (SMD) between group BA and waiting list was 0.72. This would cause few people to question the findings, but actually it means the results are of doubtful clinical relevance, as it actually means there is less than one standard deviation in outcome between the treated group and the waiting list. If a group of depressed patients had a mean Beck Depression Inventory Score of 28 at the start of treatment, [assuming that the spread of the results was 7, the standard deviation – taken from the Scott and Stradling (1990) study Behavioural Psychotherapy, 18, 1-19 ] a mean score of 23 at the end of treatment would produce an SMD of 0.71, i.e about the same as in the University of Sheffield analysis. Thus the average person experiencing this change of score is unlikely to feel that they are back to their normal selves, and are likely to view it as part of the normal cycling of mood, influenced by positive events e.g the company/support of fellow sufferers for a time in a group. In none of the Group BA studies was there an independent assessor determining whether clients were still depressed or the permanence of any change. Unsurprisingly the authors found that the Group BA was no better than any other active treatment (i.e controlling for attention and expectation), and make an implicit plea for the Dodo verdict ‘all therapies are equal and must have prizes’.

In the body of the BA paper the authors acknowledge that the Group BA studies are of low quality, save one and that analyses were on treatment completers as opposed to the more rigorous intention to treat. But there is no indication anywhere as to what proportion of people recover from depression with any permanence.

In 1990 Steve Stradling and I had published [Behavioural Psychotherapy, 18, 1-19] a study of depressed clients comparing, group CBT, individual CBT and a waiting list condition. For Group CBT the initial mean BDI was 29.0 and end of treatment score was 6.2 whilst for individual treatment the comparable scores were 28.21 and 11.53. However those on the waiting list also improved from 25.89 initially to 20.26 at the end of waiting list. Thus, it is far from clear that the results from the University of Sheffield analysis on Group BA are actually better than those of putting people on a waiting list.

Dr Mike Scott

 

 

 

 

 

The Proposed NICE (Mis)Guidance on the Treatment of Depression

excludes consideration of assessment https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0725/consultation/html-content-3, in it’s’ update of the 2009 Guidance [CG90], despite advocating different pathways for ‘less’ and ‘more severe’ depression, advocating a cut-off of 16 on the PHQ-9.! De facto the authors rubber-stamp the widely held practice, reflected in the Improving Access to Psychological Therapies (IAPT) Service, of routing high scorers on a depression psychometric test (e.g PHQ-9 score 10 or greater) to treatment for this condition. But patients with a wide range of disorders including, panic disorder, PTSD, obsessive compulsive disorders and adjustment disorder have elevated depression scores. Nevertheless NICE signals a diversion along a depression pathway with one fork for ‘less severe’ and another for the ‘more severe’. Clinicians and clients are likely to be equally bemused by the ‘road signs’. The upshot is likely to be misguided treatment.

In assessing the outcome studies NICE do not take seriously the concept of minimally important difference (MID) i.e what change would a a patient see as the minimum requirement necessary for them to say treatment has made a real world difference. There is no evidence that they would regard a change of score on a psychometric test as conferring a real world difference. But they would recognise being back to their old self or best functioning and possibly no longer suffering from the disorder, so that loss of diagnostic status would be a reasonable proxy for a MID. However only a minority of studies furnish this data with the use of blind assessors. Inferences can therefore only be properly drawn from this sub-population of studies, which exclude the low intensity studies.

Under the proposed Guidance client’s preferences are paramount.  If the client is judged as having ‘less severe’  depression and volunteers no treatment preference, they are to be taken through  a menu of options in a set order starting with first group cognitive behavioural therapy, second group behaviour activation, third individual CBT and on to the 11th option short-term psychodynamic therapy.  For ‘more severe’ depression top of the league is individual CBT plus antidepressants, in 2nd place individual CBT, and in 3rd place individual behavioural activation and in last and 10th place is group excercise. The ‘more severe’ route is more labour intensive and there is likely to be congestion as approximately half those entering IAPT have mean scores of 15 or more on the PHQ-9 [Saunders et al (2020) https://doi.org/10.1017/S1754470X20000173]. Unwittingly the Guidance spells the end of low intensity interventions because none of the top of the league options are low intensity! But 70% of clients entering the IAPT service are given a low intensity intervention first. However there is nothing to prevent a Service Provider declaring that ‘unfortunately none of the top of the league options are currently available’ and recourse has to be made to options in danger of relegation. So much for NICE Compliance and patient choice. 

The NICE guidance assumes that psychometric test results speak for themselves but they are only meaningful when described in context. To my knowledge there is no study of the reliability of the PHQ-9 in UK routine mental health services compared to a ‘gold standard’ diagnostic interview. Rather data on the PHQ-9 has been extrapolated from from US studies of psychiatric outpatients, in a population with a high prevalence of depression, but not using a ‘gold standard’ diagnostic interview [The Prime MD was used instead, with insufficient distinction between this interview and the questions on the PHQ-9]. It is the author’s experience that in the UK the PHQ-9 gives a large number of false positives compared to a reliable diagnostic interview, such as the SCID.

NICE has a ‘blind spot’ about context. In its’ analysis of outcome studies it lumps together ‘depression studies’ that were wholly reliant on self-report measures with those that included the results of a diagnostic interview as an outcome measure. Outcome is assessed in terms of statistical differences between either different modes of service delivery e.g stepped v non-stepped or between different treatments e.g CBT v waiting list. There was no attempt to try and discern what proportion of clients in each arm of a study would have regarded themselves as back to their normal selves or best functioning post treatment [ or in lieu of this, lost their diagnostic status] and the duration of those gains. Rather than patients being asked to cite preferences over treatments they largely have no knowledge of, they would be very interested as to the likelihood of treatment making a real world difference to their lives.

NICE’s failure to look at context is highlighted in the top league place it gives to group CBT for less severe depression. No mention that in our study [Scott and Stradling (1990)https://doi.org/10.1017/S014134730001795X ] of individual and group CBT for depression in Toxteth, Liverpool the invitation to group CBT went down like a ‘lead balloon’ and we had to change the protocol to include up to 3 individual sessions in the ‘group’ arm. Entry was determined by independent diagnostic interview, but mean entry Beck Depression scores were around 27, so the population was likely ‘more severe’ in NICE terms. NICE also fails to critically appraise the Group Behavioural Activation studies, having previously called for BA studies to include observer rated assessments. They may have also added the need for credible attention control comparisons. NICE is content with statistical sweeps at large data sets rather trying to discern what is happening at the coal face.

NICE puts group interventions as top of the league for less severe depression, but ignores the context of the pandemic, realistically how possible will it be two get 2 therapists together with 8 clients for 90 minutes a week for 8 weeks, all face to face. The logistics and effectiveness of conducting it online is a venture into the unknown. NICE appears to operate without contextualisation of findings.

NICE are open to commentary on the proposals upto January 12th 2022. Will send the above, but I don’t think I will receive a return Christmas Card any time soon. Nevertheless a Happy Christmas to everyone.

 

Dr Mike Scott

Clinical Commissioning Groups Decade of Neglect In Auditing Mental Health Pathway

no Clinical Commissioning Group has been compliant with NICE’s (2011) 1.5.1.2 https://www.nice.org.uk/guidance/cg123 injunction for them to audit and review local mental health pathways. Instead, the  CCGs have left it to the Improving Access to Psychological Therapies (IAPT) programme to mark their own homework. NHS England has turned a blind eye. Can there be a better example of institutionalised bias against mental health patients?

The National Institute for Health and Clinical Excellence (NICE) document https://www.nice.org.uk/guidance/cg123 (2011) also advocates a stepped care model that ‘provides the least intrusive  and most effective intervention first’. But this creates a conundrum in that, clearly the least intrusive interventions include, guided self-help, computerised CBT and psychoeducation groups, what would be deemed low intensity interventions in IAPT. However, the NICE recommended treatments for specific disorders, are recommended in a dosage that would be incompatible with a low intensity intervention. It is only the high dosage interventions that have been credibly systematically evaluated in randomised controlled trials. Contrary to the assertion of Boyd et al (2019) https://doi.org/10.1371/journal.pone.0214715 there is not ‘sound evidence for the efficacy of low intensity interventions’.  The methodological quality of the studies that form the basis for NICE’s recommendation for specific disorder treatments is much stronger than the foundation for the low intensity recommendations. Thus to provide ‘the most effective intervention’ first would mean jettisoning low intensity interventions and herald the demise of the stepped care model!

The mnemonic PICOT has been advocated by NHS England (2013) Finding the Evidence https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwj5_-fAhbn0AhXDiVwKHSgdDnYQFnoECBgQAQ&url=https%3A%2F%2Fwww.england.nhs.uk%2Fwp-content%2Fuploads%2F2017%2F02%2Ftis-guide-finding-the-evidence-07nov.pdf&usg=AOvVaw3-7g7wSw9WFJhtWaS-gBdX to help clinicians distinguish what is an evidence-based treatment and  what is not. The P refers to the  patient/problem/population studied, I the intervention/exposure of interest, C the comparison condition, O for outcome and T the time frame. The low intensity interventions fall at each hurdle. With regards  to P the patient population is poorly specified, with reliance on a self-report measure rather than a ‘gold standard’ diagnostic interview. The intervention used, I, is fuzzier in low intensity interventions with no indication as to how it is adapted to the needs of the individual. The comparison conditions, C are invariably waiting list controls in low intensity interventions, but patients on waiting lists do not expect to get better, the appropriate comparison is an active control group e.g attendance at a shyness group to learn from each other what works best for them. The outcome, 0, in low intensity interventions is always a change on a self-report measure, it is never complemented by an independent evaluation of the diagnostic status of the person. Finally T, there is no indication in the low intensity studies of the duration of gains i.e what proportion of those who have recovered go on to maintain their gains. Whilst not all rct’s of  high intensity interventions clear the PICOT hurdles about half do and these interventions merit a strong recommendation. These studies are qualitatively different to the low intensity studies.

 

 

It is a source of concern that the manufacturers of Silver Cloud, a computerised CBT programme, is the sponsor of a recently publicised IAPT training day. 

 

Dr Mike Scott