Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
July 18, 2018
CompletedDecember 10, 2018
December 1, 2018
6.6 years
July 23, 2012
April 26, 2018
December 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
baseline and 5 and 9 month post-intervention follow-up
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
Baseline, 5 months, 9 months
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
Baseline, 5 months, 9 months
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
baseline and 5 and 9 months post-intervention follow-up
Changes in Psychosocial Functioning
baseline and 5 and 9 month post-intervention follow-up
Study Arms (2)
Cognitive Behavioral Stress Management
EXPERIMENTALHealth Information
ACTIVE COMPARATORInterventions
Ten (10) 90-min sessions of Health Information delivered via videophones
Ten (10) 90-min sessions of T-PP-CBSM
Eligibility Criteria
You may qualify if:
- men and women diagnosed with chronic fatigue syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychology University of Miami
Coral Gables, Florida, 33124, United States
Related Publications (1)
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.
PMID: 31377502DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Antoni
- Organization
- University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
July 23, 2012
First Posted
July 26, 2012
Study Start
October 1, 2010
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
December 10, 2018
Results First Posted
July 18, 2018
Record last verified: 2018-12