NCT01650636

Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process

Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)	Ten (10) 90-min sessions of Health Information delivered via videophones
BEHAVIORAL	Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)	Ten (10) 90-min sessions of T-PP-CBSM

Timeline

• Start date: 2010-10-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2012-07-26
• Last updated: 2018-12-10
• Results posted: 2018-07-18

Locations

1 site across 1 country: United States