Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 23, 2012 | ||||||||
| Last Updated Date | December 4, 2014 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in CDC-based CFS symptoms (Total Frequency and Severity) [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ] changes in a composite (severity and frequency) of chronic fatigue syndrome symptom measures |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01650636 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Changes in Neuroimmune Functioning. [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ] changes in salivary cortisol diurnal pattern and pro-inflammatory and anti-inflammatory cytokines |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
changes in psychosocial functioning [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ] [ Designated as safety issue: No ] changes in psychosocial functioning (perceived stress, depressed mood, and social processes) |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Chronic Fatigue Syndrome | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | May 2016 | ||||||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01650636 | ||||||||
| Other Study ID Numbers ICMJE | 20100771, R01NS072599 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| 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 | ||||||||
| Information Provided By | University of Miami | ||||||||
| Verification Date | December 2014 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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