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

Tracking Information
First Submitted Date ICMJE	July 23, 2012
First Posted Date ICMJE	July 26, 2012
Results First Submitted Date	April 26, 2018
Results First Posted Date	July 18, 2018
Last Update Posted Date	July 18, 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	Complete list of historical versions of study NCT01650636 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE; (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	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	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 *	Not Provided
* 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	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	Sexes Eligible for Study: All
Ages	21 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	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	June 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP