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

This study is currently recruiting participants.
Verified April 2014 by University of Miami
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami
ClinicalTrials.gov Identifier:
NCT01650636
First received: July 23, 2012
Last updated: April 6, 2014
Last verified: April 2014

July 23, 2012
April 6, 2014
October 2010
May 2015   (final data collection date for primary outcome measure)
Change in CDC-based CFS symptoms (Total Frequency and Severity) [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ]
changes in a composite (severity and frequency) of chronic fatigue syndrome symptom measures
Same as current
Complete list of historical versions of study NCT01650636 on ClinicalTrials.gov Archive Site
Changes in Neuroimmune Functioning. [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ]
changes in salivary cortisol diurnal pattern and pro-inflammatory and anti-inflammatory cytokines
Same as current
changes in psychosocial functioning [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ]
changes in psychosocial functioning (perceived stress, depressed mood, and social processes)
Same as current
 
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Chronic Fatigue Syndrome
  • 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
  • Experimental: Cognitive Behavioral Stress Management
    Intervention: Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
  • Active Comparator: Health Information
    Intervention: Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
21 Years to 75 Years
No
Contact: Dolores Pedomo, Ph.D. dperdomo@med.miami.edu
Contact: Lynne Hudgins, B.S. 305-284-3219 lhudgins@miami.edu
United States
 
NCT01650636
20100771, R01NS072599
Yes
Michael H. Antoni, University of Miami
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
University of Miami
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP