When is evidence based practice not evidence based practice?

When it is not using the latest evidence. An article in the Cognitive Behaviour Therapist, much lauded by the Editor of the Journal, highlights this. There was no review of the latest group CBT for PTSD outcome studies see Scott (2022) Personalising Trauma Treatment: Reframing and Reimagining London: Routledge. Instead the authors relied upon the conflicted, dated, recommendations of guideline producers. Guidelines are  produced by Committee decisions with all the vagaries that entails, they are not the results of a systematic analysis of data. My book includes  a review of group CBT outcome studies for PTSD (reproduced at the end of this blog), indicating the inferiority of a group approach.

 

In this study of group CBT for PTSD, the results of 3, 8 session (2hrs per session) group programmes are summarised by the treating IAPT workers. But no standardised diagnostic interview was used at any point, so it is unknown what proportion of people lost their diagnostic status for how long. Nor whether they were truly suffering from PTSD in the first place, making independent replication impossible. It is claimed that the treatment was given to those who ‘preferred’ group therapy but this is disingenuous. In practice people are offered more immediate treatment with a group or a long wait for individual therapy, whilst they may opt for the former, it is not a preference. 

8 is The New Magic Number

The tail is wagging the dog, in that the authors have fitted in with the growing fetish for 8 sessions. Those who complete IAPT treatment typically have 7.5 sessions. Further NICE recommend, 8 group CBT therapy sessions for depression as the first line treatment for depression. But there is no empirical evidence that 8 sessions of anything makes a real-world difference. It is simply what the powers that be have decided to ration out. There is no indication of the mechanism of action of 8 sessions. If it is not possible to specify how a claimed result is achieved then the latter is suspect. BABCP has just celebrated its 50th birthday by a return to magic.

Group Treatments

Groups are an attractive option for service providers, offering the prospect of reduced waiting lists and greater access to therapy. But comparisons of group interventions show them to be inferior to individual therapy post-trauma and to offer no added benefit to treatment as usual. Kearney et al. (2021) compared the effectiveness of group cognitive processing therapy (CPT) for the treatment of PTSD with group loving-kindness meditation (LKM) which involved the silent repetition of phrases intended to elicit feelings of kindness for oneself and others. The proportion of veterans who lost their diagnostic status i.e. who no longer suffered from PTSD did not differ at the end of treatment (CPT – 29%, LKM – 27.5%). Each intervention consisted of 12 weekly 90-minute group sessions but the mean number sessions completed was only six in CPT and seven in LKM. Resick et al. (2017) found that in a population of veterans group CPT was inferior to individual CPT. Preparatory group treatment for CPT or prolonged exposure does not enhance outcome. Dedert et al. (2020) examined whether a preparatory group with a focus on psychoeducation, coping skills, sleep hygiene and an introduction to PTSD treatment options added benefit to the trauma-focussed interventions, it did not. Further, those who went through a preparatory group did less well than those who did not in whatever trauma-focussed CBT they went onto in terms of PTSD symptom reduction. There is no evidence that initial Stabilisation Groups contribute to treatment effectiveness. However, the aforementioned studies were all on veterans, so care has to be taken in generalising from the results. But a study by Mahoney et al. (2020) of women prisoners who reported a history of interpersonal violence and trauma found that a ten-session group psychoeducational programme, Survive and Thrive, conferred no benefit over treatment as usual.

There appears to be no benefit to a phase-based approach, in which the first phase has as its goal safety and stabilisation, despite the inherent attractiveness of this option.

Scott, Michael J. Personalising Trauma Treatment (p. 293). Taylor and Francis. Kindle Edition.

 

 

CBT Outcome Studies – An Example of The Problems of Generalisation

The problems of generalising from CBT randomised controlled trials can be illustrated by examining the following just published study from Clark et al (2022):

 

  1. All patients were referred by an Improving Access to Psychological Therapies (IAPT) Service if they were thought to be suffering from social anxiety disorder(SAD). But following detailed diagnostic assessment only one half were found to be suffering from the disorder. Thus it seems likely that IAPT staff, left to their own devices, would have provided inappropriate treatment for one in two patients.
  2. IAPT staff do not make assessments using standardised diagnostic interviews, so that there can  be no certainty that the results of this, or any other credible randomised controlled trial, would translate into routine practice.
  3. The three treatment  clinicians involved in the trial involved were experienced, well known clinical psychologists, unlike the therapists in routine practice. It is unlikely the latter would achieve the same outcome as the former.
  4. In the study internet delivered CBT and standard CBT were the active comparisons and the results set against a waiting list control condition. But patients on a waiting list do not expect to get better and this comparotor has therefore been termed a nocebo. Given such able clinicians, it is possible that, if they had provided an alternative treatment with a credible rationale e.g ‘managing shyness/better mixing’ with equal attention the results would not have been appreciably different. The chances of this are increased by Clark et al (2022) finding that many of the standard components of the original CBT, such as accompanying the patient to social experiments were found to be redundant.   
  5. The study authors were evaluating, the computerised CBT program that they had developed. But no mention that the study  requires independent replication because of the possibility of allegiance bias. Interestingly the authors report no conflict of interest. 
  6. The study required patients to have internet access and almost two thirds had higher education. The results may not be applicable in forgotten towns.
  7. Patients were required to have SAD as their main problem, but patients typically see themselves as having a range of difficulties and want treatment for all. In this study 30% were found to be suffering from depression. But strangely, overall the pre-treatment mean on the PHQ9 was below the cut off of 10 usually used to denote a case of depression. Further this score is much lower than the initial mean of PHQ9 scores in the IAPT population.  This creates doubts about the level of functional impairment in this population. 
  8. On the surface the study results are remarkable with 70%+ recovering from SAD and avoidant personality disorder. But the primary outcome measure was a composite of loss of diagnostic status and achieving below cut-off scores on several SAD self-report measures. There could be no certainty that the components of the composite were equally important to each patient, nor that the frequencies of say loss of diagnostic status and below cut off scores matched. The hazards of using composites has been highlighted by McCoy (2018).
  9. Patients see recovery as being free of a disorder for a meaningful length of time. Given that persistent SAD is defined in the DSM as having the disorder for at least 6months. It therefore seems reasonable to suggest that a primary outcome measure should have been being free of SAD for at least 6 months. This would have been a real world change.

This study is a salutary tale about the marketing of CBT – the takeaway message in the title is that the cost of one intervention(internet CBT) is half the cost of standard CBT. This is not to say that CBT is not of limited utility with depression and the anxiety disorders (including OCD and PTSD) but we need to assess what is of real world importance to the patient.

 

Dr Mike Scott

1 in 7 Taking Antidepressants Despite Increased Access To Psychological Therapy

Maybe the antidepressants and/or psychological therapy  are  not making a real-world difference? Is it more likely than not, that one or other of these treatments works? I do not think that I could prove either to a Court’s satisfaction. Attempts to deliver them are taking a terrible toll, with a focus on Key Performance Indicators (KPI’s) rather than the client’s story. Taking these treatments in turn:

 

Antidepressants. There has been a doubling of the prescription of antidepressants  from 2006 to 2016, followed by increases in the prescription of antidepressants for 6 years [BBC News, July 9th 2022]. The BBC News  confidently asserted that a major study proved antidepressants work, citing a link to a study published by Cipriani et al in (2018) in the Lancet. But it was only in a footnote that the BBC reporter acknowledged that the meta analysis covered, predominantly studies that looked at the effects of taking the medication for 8 weeks. There is no evidence that antidepressants alter the course of a persons mental health. Journalists like to give a human angle, and so the BBC presented an individual who had benefitted from antidepressants. But equally, I could have furnished an example of a guy I saw recently with depression as a consequence of being unable to do his manual job, because of a physical injury, who has been prescribed various SSRI’s and he has lost his libido, with a deleterious effect on his long term relationship and no loss of diagnostic status. One cannot rely on anecdotes to bolster the claim for either antidepressants or psychological therapy.

Psychological Therapy.  Billions of £’s have been spent on the Improving Access to Psychological Therapies (IAPT) Programme over the last decade.  But there has been no publicly funded independent audit of IAPT. Why? Vested interests and a deep desire to believe that antidepressants and IAPT ‘must’ be making a difference. I examined the effectiveness of CBT in routine practice for 90 IAPT clients in the course of my work as an Expert Witness to the Court Scott (2018) and found that only the tip of the iceberg recovered (i.e lost their diagnostic status) using a ‘gold standard’ semi-structured interview. Further it mattered not whether they were treated before or after their personal injury. It has been said that human beings can only take so much reality, if so, following the scientific edict to ‘follow the data’ is likely to prove more aspirational than actual.  

I cannot see any Expert Witness clearing an, on the balance of probability threshold, with regard to either of these interventions, as delivered in routine practice, in a British Court. 

 

Dr Mike Scott

 

 

NICE Rubber Stamps Business as Usual

despite the fact that the main provider of psychological services, the Improving Access to Psychological Therapies (IAPT) Service is ‘An Abject Failure’ https://www.madinamerica.com/2022/06/uk-iapt-abject-failure/. It is all about cost, with no regard for evidence. It is recommended by the National Institute for Health and Care Excellence (June 29th) that clients are offered 11 possible interventions for depression, presenting the least costly first, guided self-help, group cognitive behavioural therapy (8 sessions) progressing up to the 11th option, short term psychodynamic psychotherapy. With Psychological Wellbeing Practitioners (PWPs) providing the assessment and the least costly interventions. But PWPs are not trained therapists and the IAPT Manual states that its’ employees do not make diagnoses and they are not trained to diagnose. Yet bizarrely NICE states that assessors must be competent to make a reliable assessment of depression! A pig’s ear of monumental proportions. 

There is no empirical evidence that 8 sessions of group CBT delivered by PWPs makes a real world difference to client’s lives as assessed by a blind assessor. Nor that the recommended 8 sessions of individual CBT for depression, presumably delivered by a high intensity therapists, constitutes a therapeutic dose of treatment. 

The revision of the Draft Nice Guidance on Depression https://www.nice.org.uk/guidance/ng222 now recommends a stepped care approach to depression and sees Psychological Wellbeing Practitioners as contributing to treatment. This has brought a ‘hurrah’ from BABCP (British Association for Behavioural and Cognitive Psychotherapy),  as it is exactly what they lobbied for https://babcp.com/About/News-Press/Revised-NICE-Guideline-on-Depression-in-Adults post the Draft guidelines. Dr Andrew Beck the BABCP President proclaims in the press release ‘the guidedInes highlight the amazing value of PWPs’.  In addition antidepressants and CBT in combination are seen as the treatment choice for severe depression.

But these recommendations and changes are eminence-based not evidence-based. A paper published in the Journal of Psychiatric Research last year by Bartova et al (2021) https://doi.org/10.1016/j.jpsychires.2021.06.028 showed a 25% response rate for those who had antidepressants and manual-driven psychotherapy (mostly CBT), no better than antidepressants alone. This compares with a 31% response rate in those given a placebo Rutherford and Roose (2013) https://doi.org/10.1176%2Fappi.ajp.2012.12040474

Before BABCP issued the press release, I raised the following issues with its’ author Professor Reynolds:

  1. I can find no randomised control trials of low intensity interventions that are methodologically robust enough to lead to the conclusion that such interventions should be the initial treatment of choice for less severe depression.
  1. I can find no evidence that as a result of stepped care, the trajectory of clients with depression Is meaningfully better than if they were not treated in a stepped care model.
  2. There was criticism of the initial draft for the ‘marginalising and undervaluing of PWPS’. However, it appears that under pressure from BABCP, PWPS are now to be lauded. But there is an absence of evidence of what PWP treatment works for whom and in what circumstances. As such their interventions are not evidence- based. Further they are not psychological therapists.
  1. NICE have apparently indicated that the IAPT database may be used to inform the next set of guidelines. But this database tells us nothing of the course of any client’s disorder as the service does not make diagnoses or engage in long-term follow up.

I asked that my dissent from BABCPs press release be publicly noted, and was told simply that it would be passed to the BABCP Board. At the same time the comments of IAPTs lead, Professor Clark. on the importance of including relapse prevention in treatments, would be included in the press release and it was.  An in-group clearly operates. I am reminded that when I submitted an article to the BABCP comic, CBT Today on IAPT, the article was rejected not by the editor but by the past (Prof Salkovskis) and current (Dr Andrew Beck) Presidents of BABCP. The matter was never addressed by the Board despite an assurance from Dr Beck. If ever there was a clique. Unholy alliances rule.

Dr Mike Scott