N/A
N=300
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Chronic Fatigue Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01650636 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Jul 2018
Primary outcome: Primary: Changes in Frequency and Severity of CDC-based CFS Symptoms — 0.29; 0.12; 0.49; 0.05 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) (Behavioral); Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Frequency and Severity of CDC-based CFS Symptoms |
0.29; 0.12; 0.49; 0.05; 0.46; 0.41 | — |
| PRIMARY Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms |
1.65; 1.37; 2.62; 1.10 | — |
| SECONDARY Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol. |
0.24; -0.06; 0.08; 0.31 | — |
| SECONDARY Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines |
0.39; 0.10; 0.42; -0.32; 0.84; -0.59 | — |
| SECONDARY Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines |
0.61; 0.54; -0.06; 0.37; -0.42; -0.23 | — |
| SECONDARY Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines |
-0.43; -0.38; 0.23; -1.14 | — |
| SECONDARY Changes in Psychosocial Functioning |
-2.57; -2.84; -0.56; -3.28; -0.44; -1.36 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01650636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.