Videoconference-delivered group cognitive behavioral stress management for ME/CFS patients who present with severe PEM: a randomized controlled trial

Background: In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), post-exertional malaise (PEM) is associated with greater distress and symptoms. Cognitive Behavioral Stress Management (CBSM) has demonstrated beneficial effects for ME/CFS and may mitigate stress-related triggers of PEM. We tested a virtual CBSM intervention to increase access, and we report on its effects on stress and symptoms in ME/CFS patients with severe PEM. Methods: Data were from a randomized controlled trial (NCT01650636) comparing 10-week videoconference-delivered group CBSM (V-CBSM, n = 75) to a 10-week Health Information active control (V-HI, n = 75) in Fukuda criteria ME/CFS patients (71 classified as highPEM, 79 lowPEM). Linear regression explored PEM-by-Treatment interactions on overall symptom frequency and intensity, perceived stress, and fatigue-specific interference and intensity, at 5-month follow-up. Logistic regression tested V-CBSM effects on 5-month PEM status. Analyses controlled for age, gender, race/ethnicity, mode of symptom onset, and time since diagnosis. Results: The sample was middle-aged (47.96 ± 10.89 years), mostly women (87%) and non-Hispanic White (65%), with no group differences on these variables or baseline PEM. For highPEM patients, V-CBSM (versus V-HI) demonstrated medium to large effects on follow-up symptom frequency, symptom intensity, fatigue interference, and fatigue intensity (p’s <.05) and trending to significant reductions in perceived stress (p =.07). Differences were not evident for lowPEM patients. Treatment predicted follow-up PEM status at a trend (p =.058), with patients receiving V-CBSM demonstrating half the risk of highPEM classification versus V-HI. Conclusions: V-CBSM demonstrates benefits for ME/CFS patients presenting with severe PEM and may reduce the expression of PEM over time. Trial registration: ClinicalTrials.gov identifier: NCT01650636.