Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
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ClinicalTrials.gov Identifier: NCT01650636 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Results First Posted : July 18, 2018
Last Update Posted : December 10, 2018
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Sponsor:
University of Miami
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami
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Tracking Information | |||
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First Submitted Date ICMJE | July 23, 2012 | ||
First Posted Date ICMJE | July 26, 2012 | ||
Results First Submitted Date ICMJE | April 26, 2018 | ||
Results First Posted Date ICMJE | July 18, 2018 | ||
Last Update Posted Date | December 10, 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 |
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures |
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)
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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 ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Other |
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Condition ICMJE | Chronic Fatigue Syndrome | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
300 | ||
Original Estimated Enrollment ICMJE |
150 | ||
Actual Study Completion Date ICMJE | May 2017 | ||
Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | 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 ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | 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 | December 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |