Overview

This trial is active, not recruiting.

Condition chronic fatigue syndrome
Treatments patient-partner videotelephone-delivered health information (pp-t-hi), patient-partner videotelephone-delivered cognitive behavioral stress management intervention (pp-t-cbsm)
Phase phase 2
Sponsor University of Miami
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date October 2010
End date May 2017
Trial size 150 participants
Trial identifier NCT01650636, 20100771, R01NS072599

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Experimental)
patient-partner videotelephone-delivered cognitive behavioral stress management intervention (pp-t-cbsm)
Ten (10) 90-min sessions of T-PP-CBSM
(Active Comparator)
patient-partner videotelephone-delivered health information (pp-t-hi)
Ten (10) 90-min sessions of Health Information delivered via videophones

Primary Outcomes

Measure
Change in CDC-based CFS symptoms (Total Frequency and Severity)
time frame: baseline and 5 and 9 month post-intervention follow-up

Secondary Outcomes

Measure
Changes in Neuroimmune Functioning.
time frame: baseline and 5 and 9 month post-intervention follow-up

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Miami.