Dr. Michael Antoni Responds

CFS Central sent questions to Dr. Michael Antoni, the corresponding author of the new study, “A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome.” Below are his responses:

CFS Central:  In your study, one group of patients received cognitive behavioral stress management (CBSM) for 12 weeks, while the controls participated in a psycho-educational seminar for one afternoon. In a placebo-controlled drug trial, one group of people would be given a drug and another group would be given a placebo for the entire length of the drug trial, not just one afternoon. Why didn’t the controls participate in some activity—say talk therapy—for the same 12 weeks, instead of only one afternoon?

Dr. Michael Antoni:  You raise a good point, which is the importance of using a time and attention-matched control when conducting trials determining the efficacy of interventions. In that this study was a pilot we were trying to determine feasibility of delivering the intervention, assuring that it would not be harmful, and that it would present a meaningful experience for the patients.  The one-day seminar “control” condition is best conceptualized as enhanced standard care in that it provided a minimal additional element to the patients’ ongoing standard medical treatment. For some patients this one-day experience was akin to learning self-help techniques.  Due to the lack of equivalent contact time between conditions, one cannot however, rule out the possibility that the effects of our stress management condition were due to the extra attention it offered.  Having completed this pilot work we are currently using a time and attention-matched control in our current work.

CFS Central:  In your study, the symptoms of the controls worsened over the course of the 12 weeks. CFS does not normally cause such deterioration in the short term. It’s a waxing-and-waning disease in the short term.  Why would all patient control symptoms deteriorate?  

Antoni:  To clarify, not ALL control patients showed a worsening of any outcomes over the 12 weeks, but rather these were the group mean or average pattern of change for those assigned to the control condition. Further, there was no evidence that patient controls showed changes in ALL symptoms over time. In terms of the time frame used, again since this was a pilot study the follow-up period was quite short.  Ongoing work is following patients over longer intervals.

CFS Central:  If the controls had not deteriorated, would the improvements in the treated patients be statistically significant?

Antoni:  The strongest effects observed in the stress management group were for an increase in quality of life, effects that are significant independent of control group changes. Other effects reported are a combination of improvements in stress management and decline in controls. 

CFS Central:  According to your study, 44.9 percent of the CFS patients in your study were on disability at the start of the study.  How many patients were on disability at the study’s completion?

Antoni:  We only measured disability, occupational status and assorted lifestyle and demographic variables at baseline, hence information on changes over time is not available.

CFS Central: In Table 2 in your study, it says that “perceived stress” decreased during the course of this study from 29 to 27.  What does “perceived stress” mean?

Antoni: The Perceived Stress Scale is a 14-item self-report measure that taps a respondent’s perception of the stress in their lives over the past month and gets at how overwhelmed they feel with the demands of life, how much they feel that things are mot going their way, etc.

CFS Central:  In your study, the authors state:  “This intervention has the potential to offer a reasonably low-cost self-regulatory approach to the management of this perplexing syndrome.” What do you mean by “management” when it comes to CFS?

Antoni: “Management” here refers to managing the demands and challenges of everyday life as well as the challenges of CFS in particular.   

CFS Central:  We know stress can exacerbate chronic diseases and that cognitive therapy or talk therapy might be helpful in some cases in dealing with chronic illnesses.  We’ve seen many studies attesting to the benefits of cognitive therapy with chronic disease, particularly in the case of CFS.  My question is why do we need another study to tell us the same thing, while patients are very ill or dying of CFS due to lack of efficacious treatments for their physical problems?

Antoni: The CBSM intervention tested here is broader that Cognitive therapy in that it blends a combination of anxiety reduction techniques with interpersonal and communication techniques with cognitive therapy in a supportive group to address “stress processing”.  This is quite distinct from most other Cognitive Therapy approaches that target physical activity and de-conditioning.  This is an entirely different approach.

CFS Central:  Four CFS patients I interviewed back in 1994 for the article "The AIDS Drug No One Can Have" for Philadelphia magazine, on the experimental HIV and CFS drug Ampligen, have since died from the disease. Patients die from rare cancers and heart failure 20 years earlier than their life expectancy should be.  Others are bed-bound or house-bound and experiencing seizures, chronic infections, heart failure and short-term memory loss. Do you see a disconnect in the cognitive therapy that your study advocates and the severe physical disease and death patients are experiencing? What should be done about helping these severely physically ill patients?

Antoni:  No disconnect at all.  Again the CBSM program that we used is designed to help people manage stress better in order to possibly influence neuroimmune processes that can exacerbate immunologic activation and symptoms.  This form of intervention has been shown to reduce stress, anxiety and negative mood states in parallel with salutary effects on neuroendocrine and immune system indicators in a range of populations including persons with HIV/AIDS and different cancers.  Whether or not bringing about such changes can influence CFS symptomatology is a major thrust of our current research. Whether or not CBSM can help persons who are house-bound and otherwise experience limited mobility is also a consideration in our work as we develop and test ways to deliver CBSM to patients’ homes via advances in telecommunication technology (e.g., telehealth).

CFS Central: In your article, it says: “Group-based CBT combined with body awareness and exercise training has also been shown to be effective for CFS in recent work [38].  In footnote 38, you reference this study:  “Cognitive behavioral therapy v. mirtazapine for chronic fatigue and neurasthenia.” Sixty-five of the 94 patients in that 2008 study met only the Oxford criteria of the disease, which excludes physical symptoms. This is an outdated definition of CFS.  Patients with true CFS—as opposed to simple fatigue or neurasthenia patients in this 2008 study—are physiologically ill, not mentally ill.  Why are you referencing an out-of-date definition of the disease and patients who do not have bona fide CFS?

Antoni: We referenced this article (38) because it used a group-based approach.  We use an updated definition of CFS in choosing the samples for our research and believe others should do so also.

CFS Central: In addition, large patient surveys as well as the findings of several studies and most CFS-literate physicians have concluded that exercise can cause patients with true CFS more harm than good. Are you aware of these findings?

Antoni: We are aware of these findings. No part of our intervention promotes an increase in physical activity and we do recommend that patients not change their physical activity levels without the explicit guidance of their physicians. It would be fruitful to compare the effectiveness of an approach like CBSM, that focuses on cognitive, behavioral and interpersonal techniques to better manage stress VS. cognitive behavioral therapy targeting physical de-conditioning, given that the latter has previously been promoted as an effective approach.