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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
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami

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
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
Hide Arm/Group Description 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
Arm/Group Title Cognitive Behavioral Stress Management Health Information Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[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%
1.Primary Outcome
Title Changes in Frequency and Severity of CDC-based CFS Symptoms
Hide Description 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.
Time Frame baseline and 5 and 9 month post-intervention follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Average Symptom Frequency Change at 5 months F/U 0.29  (0.77) 0.12  (0.55)
Average Symptom Frequency Change at 9 months F/U 0.49  (0.80) 0.05  (0.67)
Average Symptom Severity Change at 5 months F/U 0.46  (0.76) 0.41  (0.53)
Average Symptom Severity Change at 9 months F/U 0.59  (0.80) 0.34  (0.67)
2.Primary Outcome
Title Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
Hide Description 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.
Time Frame baseline and 5 and 9 months post-intervention follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: Units on a scale
(Frequency * Severity) Change at 5 months F/U 1.65  (3.37) 1.37  (2.38)
(Frequency * Severity) Change at 9 months F/U 2.62  (3.87) 1.10  (3.31)
3.Secondary Outcome
Title Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
Hide Description Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).
Time Frame baseline and 5 and 9 month post-intervention follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: Ug/dL
Change at 5 months F/U 0.24  (1.19) -0.06  (1.25)
Change at 9 months F/U 0.08  (1.19) 0.31  (1.86)
4.Secondary Outcome
Title Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
Hide Description Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
Time Frame Baseline, 5 months, 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CFS Patients Only were analyzed. Data for this outcome measure were not collected from partners.
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: pg/mL
IL-1a Change at 5 months F/U 0.39  (8.25) 0.10  (8.33)
IL-1a Change at 9 months F/U 0.42  (6.68) -0.32  (7.27)
IL-6 Change at 5 months F/U 0.84  (6.88) -0.59  (5.09)
IL-6 Change at 9 months F/U 0.43  (3.61) -0.30  (5.36)
TNFa Change at 5 months F/U -1.34  (15.86) 4.28  (19.64)
TNFa Change at 9 months F/U -2.52  (14.86) -1.05  (22.87)
5.Secondary Outcome
Title Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
Hide Description Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
Time Frame Baseline, 5 months, 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only CFS Patients were analyzed. Partner data was not collected for this outcome measure.
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: pg/mL
IL-4 Change at 5 months F/U 0.61  (3.93) 0.54  (3.03)
IL-4 Change at 9 months F/U -0.06  (3.09) 0.37  (2.27)
IL-5 Change at 5 months F/U -0.42  (3.26) -0.23  (4.28)
IL-5 Change at 9 months F/U -1.05  (4.73) -0.55  (3.99)
IL-10 Change at 5 months F/U -1.02  (10.53) -0.77  (10.30)
IL-10 Change at 9 months F/U 1.01  (10.90) 2.67  (26.26)
6.Secondary Outcome
Title Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
Hide Description Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).
Time Frame baseline and 5 and 9 months post-intervention follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: Ratio
Ratio Change at 5 months F/U -0.43  (5.28) -0.38  (8.55)
Ratio Change at 9 months F/U 0.23  (6.98) -1.14  (13.73)
7.Secondary Outcome
Title Changes in Psychosocial Functioning
Hide Description Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.
Time Frame baseline and 5 and 9 month post-intervention follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only CFS Patient's data were analyzed. Partner data was not collected for this outcome measure.
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: Units on a scale
PSS Change at 5 months F/U -2.57  (8.17) -2.84  (7.39)
PSS Change at 9 months F/U -0.56  (9.07) -3.28  (8.30)
CES-D Change at 5 months F/U -0.44  (10.67) -1.36  (10.18)
CES-D Change at 9 months F/U 1.66  (12.20) -3.08  (11.21)
SIP Recreation and Pastimes Change at 5 months F/U -0.95  (3.78) -0.98  (2.80)
SIP Recreation and Pastimes Change at 9 months F/U -0.23  (3.32) -0.70  (3.50)
SIP Social Interaction Change at 5 months F/U 0.95  (3.78) 0.98  (2.80)
SIP Social Interaction Change at 9 months F/U 0.23  (3.32) 0.70  (3.50)
Time Frame Adverse event collected for the duration of the study and up to 9 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Stress Management Health Information
Hide Arm/Group Description 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
All-Cause Mortality
Cognitive Behavioral Stress Management Health Information
Affected / at Risk (%) Affected / at Risk (%)
Total   1/150 (0.67%)      0/150 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Stress Management Health Information
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/150 (0.67%)      0/150 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian Cancer * 1  1/150 (0.67%)  1 0/150 (0.00%)  0
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioral Stress Management Health Information
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/150 (0.00%)      2/150 (1.33%)    
Cardiac disorders     
Chest Pain * 1  0/150 (0.00%)  0 1/150 (0.67%)  1
Surgical and medical procedures     
Rotator Cuff Surgery * 1  0/150 (0.00%)  0 1/150 (0.67%)  1
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Antoni
Organization: University of Miami
Phone: 305-284-5466
Responsible Party: Michael H. Antoni, University of Miami
ClinicalTrials.gov Identifier: NCT01650636     History of Changes
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