Compassion Training and Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01776645
First received: January 15, 2013
Last updated: October 24, 2013
Last verified: October 2013
Results First Received: July 31, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Behavioral: Compassion Cultivation Training Course

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Compassion Cultivation Training Compassion Cultivation Training Course - Participants with Chronic Pain
Significant Others Group Significant others of the individuals with chronic pain undergoing the compassion cultivation training course

Participant Flow:   Overall Study
    Compassion Cultivation Training     Significant Others Group  
STARTED     28     28  
COMPLETED     14     14  
NOT COMPLETED     14     14  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Compassion Cultivation Training - Participants With Chronic Pa Compassion Cultivation Training Course - Participants with Chronic Pain
Significant Others Group Significant Others of Participants with Chronic Pain
Total Total of all reporting groups

Baseline Measures
    Compassion Cultivation Training - Participants With Chronic Pa     Significant Others Group     Total  
Number of Participants  
[units: participants]
  28     28     56  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     24     50  
>=65 years     2     4     6  
Age  
[units: years]
Mean ± Standard Deviation
  49.61  ± 10.59     50.71  ± 12.59     50.16  ± 11.75  
Gender  
[units: participants]
     
Female     24     7     31  
Male     4     21     25  
Region of Enrollment  
[units: participants]
     
United States     28     28     56  



  Outcome Measures
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1.  Primary:   Change in Brief Pain Inventory   [ Time Frame: Baseline and end of 9-week treatment protocol ]

2.  Secondary:   Change in Brief Pain Inventory   [ Time Frame: Baseline to end of 9-week treatment protocol ]

3.  Primary:   Change in Chronic Pain Acceptance Questionnaire   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Change in Emotional Distress   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Change in Overall Health and Well-being   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Change in Compassion   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Qualitative Measures   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Change in Emotional Distress   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Change in Emotional Distress   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   Change in Overall Health and Well-being   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Other Pre-specified:   Change in Compassion   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Other Pre-specified:   Change in Compassion   [ Time Frame: Baseline and end of 9-week treatment protocol ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Dr. Sean Mackey
Organization: Stanford University
phone: 650-724-2795
e-mail: smackey@pain.stanford.edu


No publications provided


Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01776645     History of Changes
Other Study ID Numbers: 25883
Study First Received: January 15, 2013
Results First Received: July 31, 2013
Last Updated: October 24, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board