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Compassion Training and Pain

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: NCT01776645
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Pain
Intervention Behavioral: Compassion Cultivation Training Course
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Compassion Cultivation Training Significant Others Group
Hide Arm/Group Description Compassion Cultivation Training Course - Participants with Chronic Pain Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
Period Title: Overall Study
Started 28 28
Completed 14 14
Not Completed 14 14
Arm/Group Title Compassion Cultivation Training - Participants With Chronic Pa Significant Others Group Total
Hide Arm/Group Description Compassion Cultivation Training Course - Participants with Chronic Pain Significant Others of Participants with Chronic Pain Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  92.9%
24
  85.7%
50
  89.3%
>=65 years
2
   7.1%
4
  14.3%
6
  10.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
49.61  (10.59) 50.71  (12.59) 50.16  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
24
  85.7%
7
  25.0%
31
  55.4%
Male
4
  14.3%
21
  75.0%
25
  44.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 56 participants
28 28 56
1.Primary Outcome
Title Change in Brief Pain Inventory
Hide Description Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable
Time Frame Baseline and end of 9-week treatment protocol
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain
Arm/Group Title Compassion Cultivation Training
Hide Arm/Group Description:
Compassion Cultivation Training Course - Participants with Chronic Pain
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.46  (1.29)
2.Primary Outcome
Title Change in Chronic Pain Acceptance Questionnaire
Hide Description [Not Specified]
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Brief Pain Inventory
Hide Description Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
Time Frame Baseline to end of 9-week treatment protocol
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain
Arm/Group Title Compassion Cultivation Training
Hide Arm/Group Description:
Compassion Cultivation Training Course - Participants with Chronic Pain
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.18  (1.94)
4.Other Pre-specified Outcome
Title Change in Emotional Distress
Hide Description As assessed by the Hospital Anxiety and Depression Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Change in Overall Health and Well-being
Hide Description As assessed by Ryff's psychological well-being scales
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Change in Compassion
Hide Description As assessed by Neff's Self-Compassion Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Qualitative Measures
Hide Description Qualitative analysis of interviews
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Change in Emotional Distress
Hide Description As Assessed by the PROMIS Anger Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Change in Emotional Distress
Hide Description As assessed by the PROMIS Social Isolation Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Change in Overall Health and Well-being
Hide Description As assessed by PROMIS Global Health Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Change in Compassion
Hide Description As assessed by Compassionate Love Scale adapted for close other
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Change in Compassion
Hide Description As assessed by Pommier's Compassion for Other's Scale
Time Frame Baseline and end of 9-week treatment protocol
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Compassion Cultivation Training Significant Others Group
Hide Arm/Group Description Compassion Cultivation Training Course - Participants with Chronic Pain Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
All-Cause Mortality
Compassion Cultivation Training Significant Others Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Compassion Cultivation Training Significant Others Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Compassion Cultivation Training Significant Others Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sean Mackey
Organization: Stanford University
Phone: 650-724-2795
EMail: smackey@pain.stanford.edu
Layout table for additonal information
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01776645    
Other Study ID Numbers: 25883
First Submitted: January 15, 2013
First Posted: January 28, 2013
Results First Submitted: July 31, 2013
Results First Posted: December 16, 2013
Last Update Posted: December 16, 2013