No More Psychological Studies, An Editorial

In reading the comments on patient forums about 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,” I’m struck by the passion but wonder if patients’ energy might be better served by renewing the government phone call, fax and email campaign.  Why not confront the source of the problem—the National Institutes of Health, which funded the study—and say:  No more. 

The researchers of the new study may all be well meaning, and from my Q and A with Dr. Michael Antoni, the study's corresponding author, I believe he is sincerely trying to help patients, but his agenda isn’t the same as patients’ agendas.  He doesn’t understand the real nightmare of this disease or he'd know that cognitive behavioral stress management (CBSM) is not terribly helpful. CBSM is something most patients learn over time.  They learn, among other things, to pace themselves, to distract themselves, to seek support, and to break an overwhelming project down to bite-size pieces. Are those techniques helpful?  Yes.  Do they get patients back to work or school?  No.  Do they enable patients to socialize with their friends and family regularly, or lead normal lives?  No. 

When Antoni says that CBSM is used on HIV/AIDS and cancer patients with success, I say those patients also have retroviral and chemotherapies, and that is where the real benefits come.  CBSM or cognitive behavioral therapy or talk therapy is just a little more icing on the cake. 

I believe the time has come to renew the campaign, to flood members of Congress, plus Drs. Francis Collins and Tony Fauci at the National Institutes of Health, Secretary of Health and Human Services Kathleen Sebelius, and Centers for Disease Control Director Dr. Thomas Frieden with faxes, emails and phone calls every day, saying, among other things, no more psychological studies.  No more. 

In addition, in my view it's time to stop heeding the advice of anyone who cautions ME/CFS patients to stop hounding government officials.  Are you kidding me?  Change occurs only when people make government officials so uncomfortable, so embarrassed and so beleaguered that they finally relinquish control and begin listening. 

It's my belief that patients should stop bombarding government officials with reasonable demands after the following events occur:  The psychological studies stop, more money is allocated for excellent physiological research, effective treatments are found, and patients quit being patients and, instead, live healthy lives.  

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.

Healkick

Healkick is a new forum for patients in their 20s and 30s with neuroimmune diseases, including ME/CFS, chronic Lyme, multiple chemical sensitivity, fibromyalgia, mold illness and atypical multiple sclerosis. The group’s founder, a 27-year-old chronic Lyme and ME/CFS patient named Joey, has been sick for five years. Joey identified the need for a virtual place for patients under the age of 40 to come.

“I've always been trying to find other people my age that I can socialize with in my area or even talk to just to know I'm not alone,” he explains.  “I was really outgoing back in college and made a lot of good friends, and once I got sick with this I just fell off their radar.  I became stuck in no-man's land, talking to what tended to be older patients on ME/CFS and Lyme forums, striking up good relations but just never finding patients that became ‘friends’ in the old sense.”

Play on heelkick

The name Healkick is a play on heelkick. “The kick,” Joey says, “is meant to imply liveliness and socializing.  Healing from a disease doesn’t have to be a bore and isolating, but instead can be fun and social with the right format to make this possible.”

Joey's looking to enrich his life beyond his present routine—which he hasn’t lost his sense of humor about.  “Basically, I go to Whole Foods [supermarket] for coffee and green juice at the bar in the morning, do computer work at Whole Foods (they have free WiFi!) on my computer at the bar, grab a bowl of noodles at Whole Foods, do [more] computer work at Whole Foods, [and] grab a whole chicken to take home for dinner,” he says.  “And that's all.  It's a very constrained routine, and I'm basically in a seriously committed relationship with the Whole Foods bar right near the exit door of Whole Foods (so I don't need to do much walking) to [meet] basic survival needs and work on this project simultaneously."

Mono, ME/CFS and Lyme

Joey became ill with mononucleosis five months into his first job, at PricewaterhouseCoopers in San Francisco doing corporate fraud investigation, after graduating from University of California at Berkeley.  After a “14-day fever from hell,” he became bedridden. When he didn’t improve, he moved back home to Los Angeles.  At the airport, his mother didn’t recognize him.

A year later, Joey was diagnosed with ME/CFS and eventually with chronic Lyme as well.  He’s tried a variety of treatments—from the antiviral Valtrex to immune transfer factor to Armour thyroid, plus sleep medications, steroids and antibiotics.

Remission and a crash

In 2007, he felt well enough to take an advanced physics course and join a jazz a cappella group.  Unfortunately, as happens with many patients, Joey eventually crashed. Undeterred, and frustrated with the painfully slow progress in neuroimmune research, he applied for a master's degree in health policy and management at Berkeley but couldn't make it through the rigorous one-week math camp without relapsing.  “Luckily,” Joey says, “I reconciled with the idea that I could make a deep impression on neuroimmune research and the community at large without this degree.”  

Now, Joey’s living in Las Vegas, Nevada, and looking into the experimental drugs GcMAF and Ampligen as well as targeted chemotherapies to eliminate viral reservoirs.

Joey encourages patients with any kind of neuroimmune diseases to check out Healkick. "The creation of this group was founded not based on separation of what I do consider distinct illnesses, but rather what we all have in common: isolation and need for peer support," he says.  "It really would be something if patients with all these different types of neuroimmune disease could engage each other in meaningful connection and discussion.  We can always hope, right?”

Go Ahead: Make My Day

Chronic Fatigue Syndrome: a Novel is a visceral revenge story so cinematic it feels more like a movie, as over-the-top and satisfying as Straw Dogs or Death Wish. Author Caroline T. Anderson has cast rapacious insurance company executives as the bad guys.  Out to deny ME/CFS patients their benefits, they're as evil as Nazi monster Christian Szell in the classic what-goes-around-comes-around novel, Marathon Man. 

Set on a horse farm in rural Ohio, Chronic Fatigue Syndrome hones in on fearless reporter and leggy babe Alistair McKenney, a single mother of two loyal teenagers. As the book progresses, she morphs into a female Dirty Harry; one of the men in her busy life is described as a dead ringer for Clint Eastwood. When a doctor friend asks McKenney to look into Chronic Fatigue Syndrome, she uncovers far more than she or the doctor bargained for.

Cast as a minor villain in Chronic Fatigue Syndrome is the Centers for Disease Control.  Although the agency’s Dr. William Reeves isn’t mentioned by name, it appears that’s who novelist Anderson may be writing about.

There are weaknesses in the book:  Sometimes the information conveyed about ME/CFS hails from an earnest after-school special, and the romantic B plot needs way more time to marinate before it implodes.  Yet the brisk-paced novel decidedly works. The author makes the reader feel McKenney's compassion for her bevy of animals, especially her prized horse Blue.  The tension in the book keeps building, and the ending will thrill any person touched by ME/CFS:  The good guys triumph in a showdown replete with guns, murder and determined townspeople uniting against the evildoers until no one can ignore or malign the disease anymore. 

Ah, isn’t it pretty to think so?

Caroline T. Anderson is the pen name for a reporter who suffered from ME/CFS since childhood.  After more than 40 years living with the disease, she recovered with a combination of the antiviral famcyclovir and the old-line arthritis/lupus drug methotrexate.