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

Chronic Fatigue Syndrome Clinical Trial

Official title:

Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650636
• Other study ID #: 20100771
• Secondary ID: R01NS072599
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: May 2017

Study information

• Verified date: December 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Behavioral:
• Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)
Ten (10) 90-min sessions of Health Information delivered via videophones
• Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Ten (10) 90-min sessions of T-PP-CBSM

Locations

Country	Name	City	State
United States	Department of Psychology University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Frequency and Severity of CDC-based CFS Symptoms	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.	baseline and 5 and 9 month post-intervention follow-up
Primary	Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms	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.	baseline and 5 and 9 months post-intervention follow-up
Secondary	Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.	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).	baseline and 5 and 9 month post-intervention follow-up
Secondary	Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines	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).	Baseline, 5 months, 9 months
Secondary	Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines	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).	Baseline, 5 months, 9 months
Secondary	Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines	Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1ß + IL-6 + TNF-a]:[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).	baseline and 5 and 9 months post-intervention follow-up
Secondary	Changes in Psychosocial Functioning	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.	baseline and 5 and 9 month post-intervention follow-up