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

This study has been completed.
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 19, 2017
Last verified: July 2017
  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
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

Resource links provided by NLM:


Further study details as provided by Michael H. Antoni, 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 ]
    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 ]
    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 ]
    changes in psychosocial functioning (perceived stress, depressed mood, and social processes)


Enrollment: 150
Study Start Date: October 2010
Study Completion Date: May 2017
Primary Completion Date: May 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650636

Locations
United States, Florida
Department of Psychology University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Responsible Party: Michael H. Antoni, Principle Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT01650636     History of Changes
Other Study ID Numbers: 20100771
R01NS072599 ( U.S. NIH Grant/Contract )
Study First Received: July 23, 2012
Last Updated: July 19, 2017

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

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
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 August 18, 2017