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

• 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: University of Miami
• 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: July 23, 2012
• First Posted Date: July 26, 2012
• Results First Submitted Date: April 26, 2018
• Results First Posted Date: July 18, 2018
• Last Update Posted Date: December 10, 2018
• Study Start Date: October 2010
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Chronic Fatigue Syndrome

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 18, 2018): 300
• Original Estimated Enrollment (submitted: July 25, 2012): 150
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01650636
• Other Study ID Numbers: 20100771; R01NS072599 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael H. Antoni, University of Miami
• Study Sponsor: University of Miami
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Not Provided
• PRS Account: University of Miami
• Verification Date: December 2018