Clinical trial NCT01650636: Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Official title: Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: Videophone-delivered stress management intervention
Chronic fatigue syndrome
Symptoms
Neuroimmune processes
Psychosocial
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-07-26
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.

Detailed description: The study tests the effects of a 10-week patient-partner focused videophone-delivered cognitive behavioral stress management intervention (T-PP-CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a time-attention-matched 10-week patient-partner based videophone-delivered health information (T-PP-HI) (health behavior education on nutrition, sleep and other factors) in men and women with chronic fatigue syndrome (CFS) and their partners. The study evaluates the effects of T-PP-CBSM vs T-PP-HI on patient CFS symptoms, neuroimmune processes--diurnal cortisol regulation and immune regulation (pro-inflammatory:anti-inflammatory cytokine ratio (\[IL-1β + IL-6 + TNF-α\]:\[IL-13 + IL-10\])-and psychosocial functioning at 5 months and 9 months after intervention.

Eligibility criteria: Inclusion Criteria:

* men and women diagnosed with chronic fatigue syndrome

Exclusion Criteria:

* no partner
* prior psychiatric treatment for serious psychiatric disorder (e.g., psychosis, suicidality)
* co-morbidity or medical treatment affecting the immune system
* lack of fluency in English

Primary outcomes:
measure: Changes in Frequency and Severity of CDC-based CFS Symptoms
timeFrame: baseline and 5 and 9 month post-intervention follow-up
measure: Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
timeFrame: baseline and 5 and 9 months post-intervention follow-up
Secondary outcomes:
measure: Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
timeFrame: baseline and 5 and 9 month post-intervention follow-up
measure: Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
timeFrame: Baseline, 5 months, 9 months
measure: Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
timeFrame: Baseline, 5 months, 9 months
measure: Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
timeFrame: baseline and 5 and 9 months post-intervention follow-up
measure: Changes in Psychosocial Functioning
timeFrame: baseline and 5 and 9 month post-intervention follow-up
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Department of Psychology University of Miami
state: Florida
Study officials:
References:
citation: Milrad SF, Hall DL, Jutagir DR, Lattie EG, Czaja SJ, Perdomo DM, Ironson G, Doss BD, Mendez A, Fletcher MA, Klimas N, Antoni MH. Relationship satisfaction, communication self-efficacy, and chronic fatigue syndrome-related fatigue. Soc Sci Med. 2019 Sep;237:112392. doi: 10.1016/j.socscimed.2019.112392. Epub 2019 Jul 16.