Trial Outcomes & Findings for Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process (NCT NCT01650636)
NCT ID: NCT01650636
Last Updated: 2018-12-10
Results Overview
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.
COMPLETED
NA
300 participants
baseline and 5 and 9 month post-intervention follow-up
2018-12-10
Participant Flow
Chronic Fatigue Syndrome (CFS) and their partners were recruited from CFS physicians clinics and community.
Participant milestones
| Measure |
Cognitive Behavioral Stress Management
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Intervention Phase
STARTED
|
150
|
150
|
|
Intervention Phase
COMPLETED
|
150
|
150
|
|
Intervention Phase
NOT COMPLETED
|
0
|
0
|
|
Washout up to 5 Months
STARTED
|
150
|
150
|
|
Washout up to 5 Months
COMPLETED
|
141
|
132
|
|
Washout up to 5 Months
NOT COMPLETED
|
9
|
18
|
|
5 Month Visit
STARTED
|
141
|
132
|
|
5 Month Visit
COMPLETED
|
141
|
132
|
|
5 Month Visit
NOT COMPLETED
|
0
|
0
|
|
Washout up to 9 Months
STARTED
|
141
|
132
|
|
Washout up to 9 Months
COMPLETED
|
135
|
129
|
|
Washout up to 9 Months
NOT COMPLETED
|
6
|
3
|
|
9 Month Visit
STARTED
|
135
|
129
|
|
9 Month Visit
COMPLETED
|
135
|
129
|
|
9 Month Visit
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Stress Management
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Washout up to 5 Months
Withdrawal by Subject
|
4
|
8
|
|
Washout up to 5 Months
Physician Decision
|
2
|
2
|
|
Washout up to 5 Months
Death
|
1
|
0
|
|
Washout up to 5 Months
Lost to Follow-up
|
2
|
8
|
|
Washout up to 9 Months
Withdrawal by Subject
|
4
|
2
|
|
Washout up to 9 Months
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Stress Management
n=150 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=150 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
278 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
158 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
214 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
294 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 5 and 9 month post-intervention follow-upPopulation: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
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.
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Frequency and Severity of CDC-based CFS Symptoms
Average Symptom Frequency Change at 5 months F/U
|
0.29 Units on a scale
Standard Deviation 0.77
|
0.12 Units on a scale
Standard Deviation 0.55
|
|
Changes in Frequency and Severity of CDC-based CFS Symptoms
Average Symptom Frequency Change at 9 months F/U
|
0.49 Units on a scale
Standard Deviation 0.80
|
0.05 Units on a scale
Standard Deviation 0.67
|
|
Changes in Frequency and Severity of CDC-based CFS Symptoms
Average Symptom Severity Change at 5 months F/U
|
0.46 Units on a scale
Standard Deviation 0.76
|
0.41 Units on a scale
Standard Deviation 0.53
|
|
Changes in Frequency and Severity of CDC-based CFS Symptoms
Average Symptom Severity Change at 9 months F/U
|
0.59 Units on a scale
Standard Deviation 0.80
|
0.34 Units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: baseline and 5 and 9 months post-intervention follow-upPopulation: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
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.
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
(Frequency * Severity) Change at 5 months F/U
|
1.65 Units on a scale
Standard Deviation 3.37
|
1.37 Units on a scale
Standard Deviation 2.38
|
|
Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
(Frequency * Severity) Change at 9 months F/U
|
2.62 Units on a scale
Standard Deviation 3.87
|
1.10 Units on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: baseline and 5 and 9 month post-intervention follow-upPopulation: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
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).
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
Change at 5 months F/U
|
0.24 Ug/dL
Standard Deviation 1.19
|
-0.06 Ug/dL
Standard Deviation 1.25
|
|
Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
Change at 9 months F/U
|
0.08 Ug/dL
Standard Deviation 1.19
|
0.31 Ug/dL
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline, 5 months, 9 monthsPopulation: CFS Patients Only were analyzed. Data for this outcome measure were not collected from partners.
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).
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
IL-1a Change at 5 months F/U
|
0.39 pg/mL
Standard Deviation 8.25
|
0.10 pg/mL
Standard Deviation 8.33
|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
IL-1a Change at 9 months F/U
|
0.42 pg/mL
Standard Deviation 6.68
|
-0.32 pg/mL
Standard Deviation 7.27
|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
IL-6 Change at 5 months F/U
|
0.84 pg/mL
Standard Deviation 6.88
|
-0.59 pg/mL
Standard Deviation 5.09
|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
IL-6 Change at 9 months F/U
|
0.43 pg/mL
Standard Deviation 3.61
|
-0.30 pg/mL
Standard Deviation 5.36
|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
TNFa Change at 5 months F/U
|
-1.34 pg/mL
Standard Deviation 15.86
|
4.28 pg/mL
Standard Deviation 19.64
|
|
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
TNFa Change at 9 months F/U
|
-2.52 pg/mL
Standard Deviation 14.86
|
-1.05 pg/mL
Standard Deviation 22.87
|
SECONDARY outcome
Timeframe: Baseline, 5 months, 9 monthsPopulation: Only CFS Patients were analyzed. Partner data was not collected for this outcome measure.
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).
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-4 Change at 5 months F/U
|
0.61 pg/mL
Standard Deviation 3.93
|
0.54 pg/mL
Standard Deviation 3.03
|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-4 Change at 9 months F/U
|
-0.06 pg/mL
Standard Deviation 3.09
|
0.37 pg/mL
Standard Deviation 2.27
|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-5 Change at 5 months F/U
|
-0.42 pg/mL
Standard Deviation 3.26
|
-0.23 pg/mL
Standard Deviation 4.28
|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-5 Change at 9 months F/U
|
-1.05 pg/mL
Standard Deviation 4.73
|
-0.55 pg/mL
Standard Deviation 3.99
|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-10 Change at 5 months F/U
|
-1.02 pg/mL
Standard Deviation 10.53
|
-0.77 pg/mL
Standard Deviation 10.30
|
|
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
IL-10 Change at 9 months F/U
|
1.01 pg/mL
Standard Deviation 10.90
|
2.67 pg/mL
Standard Deviation 26.26
|
SECONDARY outcome
Timeframe: baseline and 5 and 9 months post-intervention follow-upPopulation: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)
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).
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
Ratio Change at 5 months F/U
|
-0.43 Ratio
Standard Deviation 5.28
|
-0.38 Ratio
Standard Deviation 8.55
|
|
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
Ratio Change at 9 months F/U
|
0.23 Ratio
Standard Deviation 6.98
|
-1.14 Ratio
Standard Deviation 13.73
|
SECONDARY outcome
Timeframe: baseline and 5 and 9 month post-intervention follow-upPopulation: Only CFS Patient's data were analyzed. Partner data was not collected for this outcome measure.
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.
Outcome measures
| Measure |
Cognitive Behavioral Stress Management
n=75 Participants
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=75 Participants
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Changes in Psychosocial Functioning
PSS Change at 5 months F/U
|
-2.57 Units on a scale
Standard Deviation 8.17
|
-2.84 Units on a scale
Standard Deviation 7.39
|
|
Changes in Psychosocial Functioning
PSS Change at 9 months F/U
|
-0.56 Units on a scale
Standard Deviation 9.07
|
-3.28 Units on a scale
Standard Deviation 8.30
|
|
Changes in Psychosocial Functioning
CES-D Change at 5 months F/U
|
-0.44 Units on a scale
Standard Deviation 10.67
|
-1.36 Units on a scale
Standard Deviation 10.18
|
|
Changes in Psychosocial Functioning
CES-D Change at 9 months F/U
|
1.66 Units on a scale
Standard Deviation 12.20
|
-3.08 Units on a scale
Standard Deviation 11.21
|
|
Changes in Psychosocial Functioning
SIP Recreation and Pastimes Change at 5 months F/U
|
-0.95 Units on a scale
Standard Deviation 3.78
|
-0.98 Units on a scale
Standard Deviation 2.80
|
|
Changes in Psychosocial Functioning
SIP Recreation and Pastimes Change at 9 months F/U
|
-0.23 Units on a scale
Standard Deviation 3.32
|
-0.70 Units on a scale
Standard Deviation 3.50
|
|
Changes in Psychosocial Functioning
SIP Social Interaction Change at 5 months F/U
|
0.95 Units on a scale
Standard Deviation 3.78
|
0.98 Units on a scale
Standard Deviation 2.80
|
|
Changes in Psychosocial Functioning
SIP Social Interaction Change at 9 months F/U
|
0.23 Units on a scale
Standard Deviation 3.32
|
0.70 Units on a scale
Standard Deviation 3.50
|
Adverse Events
Cognitive Behavioral Stress Management
Health Information
Serious adverse events
| Measure |
Cognitive Behavioral Stress Management
n=150 participants at risk
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=150 participants at risk
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.67%
1/150 • Number of events 1 • Adverse event collected for the duration of the study and up to 9 months.
|
0.00%
0/150 • Adverse event collected for the duration of the study and up to 9 months.
|
Other adverse events
| Measure |
Cognitive Behavioral Stress Management
n=150 participants at risk
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
|
Health Information
n=150 participants at risk
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
|
|---|---|---|
|
Surgical and medical procedures
Rotator Cuff Surgery
|
0.00%
0/150 • Adverse event collected for the duration of the study and up to 9 months.
|
0.67%
1/150 • Number of events 1 • Adverse event collected for the duration of the study and up to 9 months.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/150 • Adverse event collected for the duration of the study and up to 9 months.
|
0.67%
1/150 • Number of events 1 • Adverse event collected for the duration of the study and up to 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place