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

This study is currently recruiting participants.
Verified July 2012 by University of Miami
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami
ClinicalTrials.gov Identifier:
NCT01650636
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
 Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)
Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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)


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Stress Management Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Ten (10) 90-min sessions of T-PP-CBSM
Active Comparator: Health Information Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)
Ten (10) 90-min sessions of Health Information delivered via videophones

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650636

Contacts
Contact: Dolores Pedomo, Ph.D. dperdomo@med.miami.edu
Contact: Lynne Hudgins, B.S. 305-284-3219 lhudgins@miami.edu

Locations
United States, Florida
Department of Psychology University of Miami Recruiting
Coral Gables, Florida, United States, 33124
Contact: Dolores Perdomo, Ph.D.         dperdomo@med.miami.edu    
Contact: Lynne Hudgins, B.S.     305-284-3219     lhudgins@miami.edu    
Principal Investigator: Michael H. Antoni, Ph.D.            
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

No publications provided

Responsible Party: Michael H. Antoni, Principle Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT01650636     History of Changes
Other Study ID Numbers: 20100771, R01NS072599
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Miami:
Videophone-delivered stress management intervention
Chronic fatigue syndrome
Symptoms
Neuroimmune processes
Psychosocial

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
 Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on June 18, 2013