Of all the presentations at the AACFS conference, Michael Sharpe, MD's plenary address in the Clinical Studies session was one of the most anticipated. Much of his work with Simon Wessely, MD has been hailed by many in behavioral and physiological medicine and been trounced by CFIDS/ M.E. advocates in his native Great Britain and around the world. Dr. Sharpe opened his talk by commenting on what he considers to be a misunderstanding of his research on cognitive behavioral therapy (CBT) by the press.

He said that when their CBT study was published in the British Medical Journal in 1996, "we went to great pains to point out that this approach attempted to integrate physiological and psychological aspects and it was not by any means saying that this was a purely psychological or 'in the mind' condition. That did not stop a number of newspapers from deciding that's exactly what the study said." As a result, Dr. Sharpe believes, CFS patients have an incorrect perception of his work.

"The understandable desire to get away from the suggestion that this is a psychiatric illness, I think, can force people to the opposite extreme and to say that this is the only disease which has nothing to do with the mind. I think that there's a cost to that, in terms of cutting off a whole possible range of interventions."

CBT has been used successfully in a number of conditions to achieve full or partial recovery. It is most known for producing full recovery from depression, anxiety, phobia, panic disorder and other psychiatric conditions. But it has been also helpful in easing the suffering from and helping people cope better with cancer, arthritis and heart disease. Since CFS has no universally effective treatments and some of its symptoms, such as pain and depression, respond well to CBT, it is worth trying in CFS, Dr. Sharpe believes.

The premise of CBT is that a patient's understanding of illness and the way he or she copes with it can impact the illness itself. "It does not deny the biological basis of illness, but also assumes that psychological (cognitive, behavioral and emotional) and social aspects of illness are interrelated, so that a change in one can produce change in others." Dr. Sharpe admitted, 'it is a psychological treatment, in the sense that it is administered by talking with patients and [helping them by] discussing their understanding of the condition and planning what they're going to do about it. There's an assumption of a collaborative, equal relationship between therapist and patient. They try to find out what is the truth about illness for that individual. You are empowering the patient, giving him or her independence."

CBT is not a regimented treatment; the therapist starts by helping the patient understand the impact of illness on him or her. "We deconstruct a person's illness into different categories. The focus is not only on biology, but also on what they believe about the illness, what their concerns are, what their mood state is, how are they coping with it... and we also consider their personal situation. In a chronic condition, there could be major problems with how others respond to it."

This model assumes that it is normal and expected that a person with a chronic illness will be depressed or worried about it, and that these negative thoughts can have a negative impact on general health and the disease itself. "Thoughts a person has when they're depressed, negative thoughts about their future are not just consequences of a biological process, but also factors that keep it going.

"There is actually some evidence from several studies that patients who have an exclusive, strong prediction that they have a physical disease have a worse prognosis than those who don't. The patients may be right: maybe they actually know more than their physicians about [CFS]. But it also raises the possibility that the things that go with that belief, such as loss of control and helplessness, may actually perpetuate [the illness]."

Previous studies of CBT in CFS, Dr. Sharpe said, were flawed by high drop-out rates and insufficient length of treatment. He discussed the most recent study, done by his research team and published in the January 6, 1996 issue of British Medical journal, at length. Study participants had to have: a Karnofsky score of less than 80 ("normal activity with effort: some symptoms of disease"), no "organic" cause of symptoms, no severe psychiatric illness, between six months and 10 years of illness and a primary complaint of fatigue. Of 123 patients referred to the study, 61 did not meet the criteria and two refused treatment, leaving 60 patients in the study; 30 who received CBT plus standard medical care and 30 who received only standard medical care.

Treatment consisted of 16 hours of therapy over five months. CBT subjects were encouraged to gradually increase and stabilize activity, with the goal of breaking the activity-relapse cycle which occurs when CFS patients do too much when they feel better and then crash as a result. The therapist helped the patient deal with the ramifications of recovery, including explaining it to family members and employers.

At the end of therapy, 26.6% of CBT subjects and 16.6% of controls showed improvement, as defined by a Karnofsky score of 80 or more and a 10-point rise in baseline Karnofsky score. When study participants were reexamined at eight and 12 months, a surprising trend emerged. At eight months, 46.6% of CBT and 26% of controls had improved, and at 12 months 100% of CBT and 23.3% of controls had improved.

Another study which compared CBT to relaxation therapy found that, after six months, 70% of CBT subjects and 16% of relaxation therapy subjects improved.

Dr. Sharpe summarized the research by saying a mind-body dualism in medicine inhibits research and treatment; improvement following CBT doesn't mean that CFS is "all in the head" but psychological factors are relevant to the disease process; and, on the positive side, 'it looks like CFS may be at least partially reversible."

Dr. Sharpe's talk invited a number of comments and questions from the audience. Sarah Shepherd, RN, a support group leader from Virginia, said that exercise increases self-efficacy and multiple sclerosis advocates believe that doing no exercise is bad. Dr. Sharpe said that the CBT therapist must believe in the importance of somatic factors and commented that mental health workers can have a bias against the physiological, just as medical doctors can be biased against the psychological.

Dr. Andrew Lloyd, who did an earlier CBT study in which he found no benefit to CFS patients, commented that treating the various aspects of illness, as CBT does, should be considered "standard medical care." Dr. Sharpe responded by agreeing, but said the mind-body dualism in medicine prevents this from occurring in real life.

An Evaluation of CBT with Long-Term Follow-Up
Seventy-one CFS patients (1994 criteria) referred by disability carriers, employers and physicians were enrolled in a multidisciplinary rehabilitation program consisting of medical management, pharmacological treatment of any affective disorders and a comprehensive cognitive behavioral treatment (CBT) program. Richard Marlin, MD of McMaster University in Ontario, echoed Dr. Sharpe's earlier comments that the use of CBT or psychological therapies does not mean that CFS is not real or that it is "all in the mind," rather that CFS is a complex phenomenon and that there are ways of helping patients manage better with the disease.

CBT was administered by a therapist in each patient's own environment. Although each plan was tailored to the individual's needs, all included: structured physical exercise and activation, sleep management, activity management, regulation of stimulant medications, reduction in use of symptomatic medication, cognitive intervention to help patients deal with their beliefs about CFS, family participation and vocational and avocational goalsetting. Treatment lasted an average of six months.

Of 71 cases, 51 received CBT and 20 did not, usually because the patient's insurance company refused to pay for treatment or the patient chose not to participate. The patients who received CBT had been ill an average of 42 months and had been on work disability for 23 months; the control group (which was assessed, but not treated) had been ill an average of 66 months and on disability for 39 months.

At the end of treatment, more than 80% of patients on CBT improved.

• Thirty-one returned to work, although not necessarily in their former occupation, because "in some cases, patients made a very explicit decision that the demands and stresses of their prior employment may have been a contributing factor [to their illness] and they would like to return to different employment."

• Fourteen were in a "full-time work equivalent" situation (such as training for a new occupation), meaning the physicians, insurers and patients agreed that "they were functionally capable of working, but they were either looking for a job, retraining or doing something else. "

• Six remained disabled ' with respect to gainful employment and continued on disability benefits from their insurers," Dr. Marlin said.

The results seemed to hold up over time: when 17 patients were re-evaluated, most of those who were working or capable of work at the end of treatment were working 33 months later and two who were disabled at the end of treatment were still disabled.

In the question-and-answer session which followed, an audience member from Canada commented that the study's outcome measures were subjective, some patients relapsed while in the study and patients who were referred by their disability carriers may have been forced to comply with the study to keep their benefits. Dr. Marlin replied that "we were able to persuade private disability carriers to fund this assistance for patients and I think 'returning to work' is an objective and real-world measure" of improvement. He also said that patients weren't threatened with revocation of benefits; if that were the case, the six patients who remained disabled wouldn't have continued to receive benefits.

Lisa Crean, a CFS patient and newspaper reporter from Hawaii, asked about the functional status of patients at the start of the study because "there's a great variation between not being able to work and not being able to leave your bed." Dr. Marlin replied that cognitive and physical assessments were made and "it was our judgment that they were quite far removed from being able to work, but they weren't all confined to bed." Dr. Linda Miller Iger proposed that coping skills learned in CBT free the energy normally expended on worrying, allowing patients to improve activity and function.