Guided Self-Help May Benefit Unexplained Pain, Fatigue

Megan Brooks

July 27, 2011

July 27, 2011 — A guided self-help treatment adapted from cognitive behavior therapy (CBT) may be a "potentially useful first step" in treating patients with medically unexplained, functional or psychogenic symptoms, such as pain, weakness, and fatigue, results of a new study indicate.

According to the study, published online July 27 in Neurology, patients who received guided self-help plus usual care were twice as likely to report improvements in overall health as those who received only usual medical care.

"This trial provides initial evidence that CBT-based guided self-help for neurology patients with functional symptoms is feasible to deliver and acceptable to the patients and produces better outcomes than [usual care] alone, at least in the short term," the study authors conclude.

"Any patient with unexplained symptoms may be a candidate for this kind of approach, although the self-help guide would have to be written to include the symptoms that they experience," first study author Michael Sharpe, MD, of Psychological Medicine Research, University of Edinburgh, Scotland, told Medscape Medical News.

"This approach is likely to be particularly useful for those patients who are interested in undertaking self-help," he added.

Common Encounters

Neurologists frequently encounter patients with vague symptoms unexplained by organic disease, the study authors write. Intensive CBT can reduce these symptoms, as well as the distress and disability they cause, but there are obstacles to its use; therapists trained in CBT are not always available and patients may not be accepting of CBT or referral to a mental health professional.

Dr. Sharpe and colleagues tested the guided self-help approach they devised in 127 outpatients from 2 neurology services in the United Kingdom. All of them had functional symptoms rated by the neurologists as "not at all" or only "somewhat" explained by organic disease. The subjects mean age was 43 years, and 70% were women.

The 10 most common concerns were tingling, pain, numbness, headache, weakness, dizziness, fatigue, tremor/shaking, visual disturbance, and blackouts. Generalized anxiety (38%) and panic disorder (56%) were the most common psychiatric diagnoses. Nearly half of subjects said they were not working for health reasons, and three-fourths reported having their symptoms for more than 1 year.

Study subjects were randomly allocated to usual care alone or with guided self-help. The guided self-help component comprises a self-help workbook developed using existing CBT-based self-help manuals for depression and anxiety plus 4 half-hour sessions with a nurse or psychologist trained in CBT.

"The self-help manual was piloted over a 12-month period with patients and iteratively modified in order to produce the final version," Dr. Sharpe explained. The manual covers a range of symptoms (the patient can select the symptoms relevant to them) and offers practical exercises in a number of techniques. The person who runs the guidance sessions "helps the patient to use the book, guiding them to the relevant sections and encouraging them to complete the homework tasks," Dr. Sharpe said.

Reduced Symptom Burden

At 3 months, subjects who received guided self-help plus usual care reported a significantly greater improvement in self-rated health on the clinical global improvement scale (CGI) (adjusted common odds ratio [OR], 2.36; 95% confidence interval [CI], 1.17 – 4.75; P = .016), compared with those who received usual care.

"The treatment effect was of moderate size with a 13% difference between treatment arms in participants rating themselves as better or much better (corresponding to a number needed to treat of 8)," the investigators report.

Subjects in the guided self-help group also had a greater easing of their presenting symptoms (adjusted common OR, 2.33; 95% CI, 1.19 – 4.56; P = .014) and a reduced symptom burden (adjusted mean difference, −0.99; 95% CI, −1.73 to −0.25; P = .009) at 3 months.

There were no between-group differences in physical function, anxiety, or depression at 3 months, although "health anxiety" was lower in the guided self-help arm and satisfaction with treatment was higher in this group.

At 6 months, the added effect of guided self-help on improvement on the CGI was smaller and was no longer statistically significant (adjusted common OR, 1.45; 95% CI, 0.75 – 2.83; P = .27), the investigators report.

"There was, however, a greater improvement in presenting symptoms, less belief in the symptoms being permanent, greater satisfaction with care, and a clinically significant 11-point difference on the Short Form-12 physical functioning scale," they report.

"There may be a role for some longer term (perhaps telephone) contact with the patient to help them to keep using the manual to consolidate and maintain the gains they have made," Dr. Sharpe commented.

The relatively short follow-up period, the subjective nature of the problems being addressed, and the self-reporting of improvement are limitations of the study, the study authors note.

Placebo Response?

Reached for comment on the study, Kenneth M. Heilman, MD, professor of neurology and health psychology, University of Florida College of Medicine, Gainesville, and a member of the American Academy of Neurology, cautioned against drawing firm conclusions from this trial.

"With the design of the study, you really can't tell if the therapy is specifically helping or whether or not this is just a placebo response," he commented. The approach also seems "fairly intense" and probably would cost a "fair amount of money," he added.

With more study, though, "I do hope it works," Dr. Heilman said, "because these are not trivial problems. A lot of people suffer with these problems, and very often as a neurologist we really don't know what to do with them. But to me, this study is not fait accompli."

The study was supported by the United Kingdom Medical Research Council. Dr. Sharpe has disclosed that he serves as an independent advisor to AEGON Insurance, receives publishing royalties from Oxford University Press, Wiley-Blackwell, and Churchill Livingstone, and serves on the DSM-5 Work Group for the American Psychiatric Association. A complete list of author disclosures is listed with the original article. Dr. Heilman has disclosed no relevant financial relationships.

Neurology. 2011;77:564-572. Abstract

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