Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01650636 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Results First Posted : July 18, 2018
Last Update Posted : December 10, 2018
|
Sponsor:
University of Miami
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other |
Condition |
Chronic Fatigue Syndrome |
Interventions |
Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM) |
Enrollment | 300 |
Participant Flow
Recruitment Details | Chronic Fatigue Syndrome (CFS) and their partners were recruited from CFS physicians clinics and community. |
Pre-assignment Details |
Arm/Group Title | Cognitive Behavioral Stress Management | Health Information |
---|---|---|
![]() |
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM | Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones |
Period Title: Intervention Phase | ||
Started | 150 | 150 |
Completed | 150 | 150 |
Not Completed | 0 | 0 |
Period Title: Washout up to 5 Months | ||
Started | 150 | 150 |
Completed | 141 | 132 |
Not Completed | 9 | 18 |
Reason Not Completed | ||
Withdrawal by Subject | 4 | 8 |
Physician Decision | 2 | 2 |
Death | 1 | 0 |
Lost to Follow-up | 2 | 8 |
Period Title: 5 Month Visit | ||
Started | 141 | 132 |
Completed | 141 | 132 |
Not Completed | 0 | 0 |
Period Title: Washout up to 9 Months | ||
Started | 141 | 132 |
Completed | 135 | 129 |
Not Completed | 6 | 3 |
Reason Not Completed | ||
Withdrawal by Subject | 4 | 2 |
Lost to Follow-up | 2 | 1 |
Period Title: 9 Month Visit | ||
Started | 135 | 129 |
Completed | 135 | 129 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cognitive Behavioral Stress Management | Health Information | Total | |
---|---|---|---|---|
![]() |
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM | Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones | Total of all reporting groups | |
Overall Number of Baseline Participants | 150 | 150 | 300 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 150 participants | 150 participants | 300 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
138 92.0%
|
140 93.3%
|
278 92.7%
|
|
>=65 years |
12 8.0%
|
10 6.7%
|
22 7.3%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 150 participants | 150 participants | 300 participants | |
Female |
78 52.0%
|
80 53.3%
|
158 52.7%
|
|
Male |
72 48.0%
|
70 46.7%
|
142 47.3%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 150 participants | 150 participants | 300 participants | |
Hispanic or Latino |
37 24.7%
|
49 32.7%
|
86 28.7%
|
|
Not Hispanic or Latino |
113 75.3%
|
101 67.3%
|
214 71.3%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 150 participants | 150 participants | 300 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
2 1.3%
|
2 0.7%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
2 1.3%
|
1 0.7%
|
3 1.0%
|
|
White |
148 98.7%
|
146 97.3%
|
294 98.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
1 0.7%
|
1 0.3%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Michael Antoni |
Organization: | University of Miami |
Phone: | 305-284-5466 |
EMail: | mantoni@miami.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael H. Antoni, University of Miami |
ClinicalTrials.gov Identifier: | NCT01650636 |
Other Study ID Numbers: |
20100771 R01NS072599 ( U.S. NIH Grant/Contract ) |
First Submitted: | July 23, 2012 |
First Posted: | July 26, 2012 |
Results First Submitted: | April 26, 2018 |
Results First Posted: | July 18, 2018 |
Last Update Posted: | December 10, 2018 |