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

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ClinicalTrials.gov Identifier: NCT01650636
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : July 18, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami

Tracking Information
First Submitted Date  ICMJE July 23, 2012
First Posted Date  ICMJE July 26, 2012
Results First Submitted Date  ICMJE April 26, 2018
Results First Posted Date  ICMJE July 18, 2018
Last Update Posted Date December 10, 2018
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Changes in Frequency and Severity of CDC-based CFS Symptoms [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]
    Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.
  • Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]
    Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Change in CDC-based CFS symptoms (Total Frequency and Severity) [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]
changes in a composite (severity and frequency) of chronic fatigue syndrome symptom measures
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol. [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]
    Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).
  • Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines [ Time Frame: Baseline, 5 months, 9 months ]
    Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
  • Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines [ Time Frame: Baseline, 5 months, 9 months ]
    Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
  • Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]
    Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).
  • Changes in Psychosocial Functioning [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]
    Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Changes in Neuroimmune Functioning. [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]
changes in salivary cortisol diurnal pattern and pro-inflammatory and anti-inflammatory cytokines
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: July 25, 2012)
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)
 
Descriptive Information
Brief Title  ICMJE Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Official Title  ICMJE Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Milrad SF, Hall DL, Jutagir DR, Lattie EG, Czaja SJ, Perdomo DM, Ironson G, Doss BD, Mendez A, Fletcher MA, Klimas N, Antoni MH. Relationship satisfaction, communication self-efficacy, and chronic fatigue syndrome-related fatigue. Soc Sci Med. 2019 Sep;237:112392. doi: 10.1016/j.socscimed.2019.112392. Epub 2019 Jul 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2012)
150
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01650636
Other Study ID Numbers  ICMJE 20100771
R01NS072599 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael H. Antoni, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE Not Provided
PRS Account University of Miami
Verification Date December 2018

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