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

ABSTRACT

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..

KEYWORDS:

• myalgic encephalomyelitis
• chronic fatigue syndrome
• post-exertional malaise
• cognitive behavioral stress management

Disclosure of interest

Michael H. Antoni discloses that he is a paid consultant for Blue Note Therapeutics and Atlantic Healthcare, two digital health software companies. He is also an inventor of cognitive behavioral stress management (UMIP-483) and receives royalties for books, treatment manuals and other products associated with this intervention. The other authors declare no conflicts of interest.

Data availability statement

The data presented in this study are available on request from the corresponding author.

Additional information

Funding

This work was supported by the National Institute of Neurological Disorders and Stroke (grant number R01NS072599). Devika R. Jutagir was supported by U54CA137788, T32CA009461, and P30CA008748.

Notes on contributors

Marcella May

Marcella May received her Ph.D. in clinical health psychology from the University of Miami in 2023, after completing her clinical internship at the University of Miami Counseling Center. She is working towards licensure as a clinical psychologist in the state of Florida.

Sara F. Milrad

Sara F. Milrad is a second-year psychiatry resident at University of Maryland/Sheppard Pratt in the Physician Scientist Training Program. She obtained her Ph.D. in Behavioral Medicine with a special interest in psychoneuroimmunology and psychoneuroendocrinology under the mentorship of Dr. Michael Antoni.

Dolores M. Perdomo

Dolores M. Perdomo is an Assistant Professor in the Department of Psychiatry with over 30 years of experience in geriatrics, dementia care, and chronic medical conditions. She is faculty at the Center for Cognitive Neuroscience and Aging (CNSA), Department of Psychiatry and Behavioral Sciences. As a licensed clinical social worker in the State of Florida she is among a selective group of faculty members at the University of Miami Department of Psychiatry with the expertise to provide competent care to older adults (55+) and their care partners and cancer patients. She is an academic professor and an accredited clinical supervisor in social work, mental health, and family therapy and has been involved in supervising graduate students in these fields. She has also collaborated as Co-Investigator and played a central role on numerous national clinical research and clinical trial studies with dementia caregivers and patients with chronic conditions focused on delivering and adapting evidenced-based interventions to be remotely delivered. She has published in several journal articles, abstract posters, and book chapters on interventions for older adults, caregivers, and chronic diseases such as ME/CFS, breast cand prostate cancer.

Sara J. Czaja

Sara J. Czaja is a Professor of Gerontology and the Director of the Center on Aging and Behavioral Research at Weill Cornell College of Medicine. She is also the Director of the Center on Research and Education for Aging and Technology Enhancement (CREATE), which focuses on the interface between older adults and technology systems and the Co-Director of the ENHANCE (Enhancing Neurocognitive Health, Abilities, Networks, & Community Engagement) Center, which focuses on technology support for older adults with a cognitive impairment. Her research interests include: aging and cognition, family caregiving, aging and technology, training, and functional assessment. She is a fellow of the American Psychological Association, the Human Factors and Ergonomics Society and the Gerontological Society of America.

Devika R. Jutagir

Devika R. Jutagir is an Assistant Attending Psychologist at Memorial Sloan Kettering Cancer Center and an Assistant Professor of Psychology in Clinical Psychiatry at Weill Cornell Medical College. She received her PhD in clinical health psychology at the University of Miami, completed her clinical psychology internship at Yale University School of Medicine, and completed a postdoctoral fellowship in psycho-oncology at Memorial Sloan Kettering Cancer Center.

Daniel L. Hall

Daniel L. Hall is a licensed clinical health psychologist and an Assistant Professor in Psychiatry at Harvard Medical School (HMS). His research seeks to bridge behavioral oncology, mental health, and behavioral sciences, as reflected in his faculty appointments in the Massachusetts General Hospital (MGH) Department of Psychiatry, MGH Behavioral Medicine, MGH Mongan Institute Health Promotion and Resiliency Intervention Research Center, MGH Cancer Center Psychiatric Oncology Services, and MGH Benson-Henry Institute for Mind Body Medicine. To date, these collaborations have resulted in continuous grant funding since 2015, 57 publications, over 75 national and international conference presentations, early career awards, and mentorship of junior pre- and postdoctoral trainees.

Nancy Klimas

Nancy Klimas is the Director of the Institute for Neuro-Immune Medicine, Assistant Dean of Research and Professor of Clinical Immunology at the Dr. Kiran C. Patel College of Osteopathic Medicine. She chairs the Department of Clinical Immunology at Nova Southeastern University. Dr. Klimas is Professor Emerita, at the University of Miami's Miller School of Medicine where she practiced for 30 years, a diplomat of the American Board of Internal Medicine, a diplomat in Diagnostic Laboratory Immunology, and Director of Environmental Medicine Research at the Miami Veterans Affairs Medical Center Geriatric Research Education and Clinical Center (GRECC). 

Michael H. Antoni

Michael H. Antoni is Director of the Health Psychology Division in the Department of Psychology at the University of Miami, Sylvester Professor of Psychology and Psychiatry and Behavioral Sciences at the University of Miami, a College of Arts & Sciences Cooper Fellow, a member of the Cancer Control research program at the Sylvester Comprehensive Cancer Center (SCCC) and the Miami Center for AIDS Research (CFAR), and a licensed psychologist in the State of Florida. He has received extensive continuous extramural support from NIH for the past 3 decades and published numerous journal articles, books, book chapters and abstracts on biobehavioral medicine topics including effects of stress factors, social resources and stress management interventions on psychological adaptation, neuroimmune processes, and clinical health outcomes in chronic diseases such as HIV/AIDS, ME/CFS, and breast, prostate and cervical neoplasias.