Sharpe (non-CFS): Guided self-help for functional (psychogenic) symptoms: a randomized controlled

Esther12

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I was just reading this fun publication: 'Stepped care for functional neurological symptoms
A new approach to improving outcomes for a common neurological problem in Scotland.'

I came upon a section that reminded me of CFS spin:

In an attempt to overcome this problem, the Symptom Management Research Trial (SMART) in Neurology aimed to distil CBT into a more time efficient form of therapy using a therapy manual23 and 4 x 30 minutes of therapy time to guide patients through it. This model was tested in a randomised controlled trial in new neurology patients in Glasgow and Edinburgh4. The two therapists had nursing or psychology backgrounds. The therapy manual was designed to help patients gain a better understanding of their functional neurological symptoms and how these symptoms were arising in their body. There were exercises and ‘homework’ for the patients to complete between sessions. During the sessions the therapists could go over the material, dealing with questions arising and making further suggestions for changes in behaviour at home.

The patients recruited into the trial were more disabled than the typical patient with functional neurological symptoms in SNSS. One third had experienced their symptoms for more than 5 years and 45% were not working. However, there were clear benefits after treatment. Their presenting symptoms were significantly better at 3 and 6 months and their overall physical function was better at 6 months. Overall there was a 13% absolute difference in the numbers of patients who were ‘better’ or ‘much better’. This is an impressive result given the severity and duration of the symptoms and the brevity (and low cost) of the treatment.

This evidence suggests that a substantial number of patients would benefit from a brief and low cost, low intensity – but individually tailored – therapeutic intervention from a therapist specifically trained in the treatment of functional neurological symptoms. This creates an opportunity to provide a service to patients who currently do not have access to beneficial treatment, but have substantial disability and who are consuming unnecessary NHS resources in a largely fruitless search for help. However, it is well recognised that the routine implementation of research proven brief therapies often fails owing to a lack of a similar level of high quality supervision compared with the original trials. Therefore, the therapists should be under the supervision of a senior clinician within a national supporting framework to standardise delivery, and evaluate the outcomes, both in terms of effectiveness and cost-effectiveness.
I decided to try to find the trial to have a look, and it seems that it was a Sharpe one that found no difference between treatment and control groups in their primary outcome measure at six months, and the 'control' group was just usual care. What a great 'opportunity'.

Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial.

Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A.
Source

University of Edinburgh, Edinburgh, Scotland, UK. michael.sharpe@psych.ox.ac.uk
Abstract

OBJECTIVES:

Functional (psychogenic or somatoform) symptoms are common in neurology clinics. Cognitive-behavioral therapy (CBT) can be an effective treatment, but there are major obstacles to its provision in practice. We tested the hypothesis that adding CBT-based guided self-help (GSH) to the usual care (UC) received by patients improves outcomes.
METHODS:

We conducted a randomized trial in 2 neurology services in the United Kingdom. Outpatients with functional symptoms (rated by the neurologist as "not at all" or only "somewhat" explained by organic disease) were randomly allocated to UC or UC plus GSH. GSH comprised a self-help manual and 4 half-hour guidance sessions. The primary outcome was self-rated health on a 5-point clinical global improvement scale (CGI) at 3 months. Secondary outcomes were measured at 3 and 6 months.
RESULTS:

In this trial, 127 participants were enrolled, and primary outcome data were collected for 125. Participants allocated to GSH reported greater improvement on the primary outcome (adjusted common odds ratio on the CGI 2.36 [95% confidence interval 1.17-4.74; p = 0.016]). The absolute difference in proportion "better" or "much better" was 13% (number needed to treat was 8). At 6 months the treatment effect was no longer statistically significant on the CGI but was apparent in symptom improvement and in physical functioning.
CONCLUSIONS:

CBT-based GSH is feasible to implement and efficacious. Further evaluation is indicated.
CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that CBT-based GSH therapy improves self-reported general health, as measured by the CGI, in patients with functional neurologic symptoms.
Full text available here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149156/

The failure to attempt proper control groups for psychological RCTs just seems crazy (or corrupt), especially if you're relying upon subjective self-reported questionnaires as an outcome measure. That they still failed to reach significance at six months is embarrassing.... that this is still being presented as good evidence to justify the expansion of services is mystifying... and people are complaining about NHS cutbacks? Maybe we should be focusing on treatments where there's good evidence of efficacy at the moment?

Also, I was quite proud of this little bit from the Scottish report:

Patients with organic neurological disease and co-morbid psychological problems clearly also have significant needs and require a separate strategy, not discussed here. Also we are not considering patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
I'm probably fooling myself, but I imagined the writer thinking: "We know you weird CFS patients go around checking up on the claims in reports like these and getting angry... we're not saying that you don't fall within what should be our remit, but we're leaving you alone, so just leave us alone too. We'll even put the ME bit first!!"
 

Esther12

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Just saw some coverage of this from when it came out: http://www.sciencedaily.com/releases/2011/07/110727161244.htm

New Therapy May Help People With Unexplained Symptoms of Pain, Weakness and Fatigue

July 28, 2011 — A new type of therapy may help people with symptoms such as pain, weakness, or dizziness that can't be explained by an underlying disease, according to a study published in the July 27, 2011, online issue of Neurology®, the medical journal of the American Academy of Neurology. These symptoms, which can also include fatigue, tingling and numbness, are also known as functional or psychogenic symptoms.
"People with these symptoms make up one-third of all clinic visits, but the outcomes are poor," said study author Michael Sharpe, MD, of the University of Edinburgh in Scotland.

Previous studies have shown that intense cognitive behavioral therapy can reduce the symptoms, distress and disability in people with these symptoms, but there are obstacles to providing this therapy. Many people do not feel psychological treatment is appropriate and resist referrals to mental health services, and therapists trained in cognitive behavioral therapy are not available in all communities.

Cognitive behavioral therapy aims to improve people's physical symptoms, emotional state and functioning by helping them to understand, and where necessary change, how they think about and respond to their symptoms and life situation.

For the study, the researchers developed a self-help workbook especially for patients with physical symptoms that was based on the therapy. A total of 62 people were given the workbook and over three months had up to four half-hour hour sessions guiding them in the use of the book with a nurse at their neurologist's office in addition to their usual medical care. They were compared to 63 people who received only their usual medical care. Most of the participants also had psychiatric diagnoses, such as panic disorder, anxiety disorder and depression.
After three months, the people who received the extra therapy were approximately twice as likely to report improvements in their overall health as those who did not receive the extra therapy. A total of 13 percent more people who received the extra therapy reported that their health was "better" or "much better" than those who received only their usual care.

After six months, there was no longer a significant difference in improvements in overall health between the two groups. However, those receiving the extra therapy continued to have greater improvement in their symptoms than those who received the usual care and also in their physical functioning. They were also more satisfied with their treatment.

"This study suggests that cognitive behavioral therapy-based guided self-help may be a new and potentially useful first step in improving the management of these challenging symptoms," Sharpe said. "This approach needs further evaluation but can be a potentially effective and cost-effective first step toward providing more help for these often neglected patients."

The study was supported by the United Kingdom Medical Research Council.
 

Sean

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Previous studies have shown that intense cognitive behavioral therapy can reduce the symptoms, distress and disability in people with these symptoms, but there are obstacles to providing this therapy.
Obstacles such as, this 'therapy' doesn't make any sustained or objectively measurable difference for patients.

Call me old fashioned, but I always thought that therapies had to have some, you know, actual therapeutic content for them to be useful and acceptable.
 

Sean

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Yeah, I know. Try as I might, I just can't get hip with this new fangled post-modern epistemology, where truth is whatever you believe it is (or maybe whatever you can convince others to believe it is). Just doesn't work for me. :rolleyes:
 

alex3619

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Obstacles such as, this 'therapy' doesn't make any sustained or objectively measurable difference for patients.

Call me old fashioned, but I always thought that therapies had to have some, you know, actual therapeutic content for them to be useful and acceptable.
Old fashioned? Or a rationalist for the new age? Maybe you are just ahead of the curve? It certainly seems like many in psychology, psychiatry and medicine are in need of a wake-up call, and asking for hard evidence would seem to be a no-brainer ... but not apparently to some in psychiatry.
 

Esther12

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Obstacles such as, this 'therapy' doesn't make any sustained or objectively measurable difference for patients.
I don't actually know much about the evidence for efficacy of treatment for those patients lumped as having functional (or whatever they choose to call it) conditions. I get the impression that there's even less good evidence either way.

I would tend to assume that within this group there are a significant sub-group who gain real benefits from CBT-type treatments, even if it's founded upon quackery for others. But then, I had assumed that CBT would be more helpful for some CFS patients than it seems to be.

I've found that with a lot of 'psychosomatic' type papers, the most compelling evidence comes from case reports - which are really little more than anecdotes which could be presented to construct an utterly misleading narrative.
 

Esther12

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I'm not sure if this is worth mentioning... but I wonder if their control group could have been even worse than usual care alone, and in fact have been intended to be a bit of a nocebo.

Treatment conditions.
All participants received UC, which was enhanced by communicating the psychiatric diagnoses made during the assessment (for example, major depression) to the patient's primary care doctor and neurologist.
If patients with symptoms of unknown cause were just being given a psychiatric diagnosis, and then no treatment, would that be expected to leave them feeling worse than if they'd not had anything? Maybe that would explain why the usual care group's results got better from 3 months to 5, while the therapy group who had spent time with a therapist they thought was trying to help them, got worse. It wouldn't surprise me if feeling of gratitude (or resentment) played a significant role in the way patients fill in questionnaires post-treatment.

This also made me think of the Chalder and Wessely 'psychoeducation post-IM RCT' which used this control group:

The control group received a standardised fact-sheet about
infectious mononucleosis, which gave no advice on rehabilitation.
Some of the spin arround this paper is discussed here: http://forums.phoenixrising.me/inde...o-educational-intervention-to-aid-reco.13326/

If they theorise that fear related to viral infection is a significant factor in CFS, they could have expected such a leaflet to have a negative affect. (Anyway - it's certainly a rubbish control for therapist time). Some of the spin around that paper is pretty bad, and worth checking out.