ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : July 18, 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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Chronic Fatigue Syndrome (CFS) and their partners were recruited from CFS physicians clinics and community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 5 periods

Period 1:   Intervention Phase
    Cognitive Behavioral Stress Management   Health Information
STARTED   150   150 
COMPLETED   150   150 
NOT COMPLETED   0   0 

Period 2:   Washout up to 5 Months
    Cognitive Behavioral Stress Management   Health Information
STARTED   150   150 
COMPLETED   141   132 
NOT COMPLETED   9   18 
Withdrawal by Subject                4                8 
Physician Decision                2                2 
Death                1                0 
Lost to Follow-up                2                8 

Period 3:   5 Month Visit
    Cognitive Behavioral Stress Management   Health Information
STARTED   141   132 
COMPLETED   141   132 
NOT COMPLETED   0   0 

Period 4:   Washout up to 9 Months
    Cognitive Behavioral Stress Management   Health Information
STARTED   141   132 
COMPLETED   135   129 
NOT COMPLETED   6   3 
Withdrawal by Subject                4                2 
Lost to Follow-up                2                1 

Period 5:   9 Month Visit
    Cognitive Behavioral Stress Management   Health Information
STARTED   135   129 
COMPLETED   135   129 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Cognitive Behavioral Stress Management   Health Information   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      78  52.0%      80  53.3%      158  52.7% 
Male      72  48.0%      70  46.7%      142  47.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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

1.  Primary:   Changes in Frequency and Severity of CDC-based CFS Symptoms   [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]

2.  Primary:   Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms   [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]

3.  Secondary:   Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.   [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]

4.  Secondary:   Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines   [ Time Frame: Baseline, 5 months, 9 months ]

5.  Secondary:   Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines   [ Time Frame: Baseline, 5 months, 9 months ]

6.  Secondary:   Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines   [ Time Frame: baseline and 5 and 9 months post-intervention follow-up ]

7.  Secondary:   Changes in Psychosocial Functioning   [ Time Frame: baseline and 5 and 9 month post-intervention follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mantoni@miami.edu



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: July 18, 2018