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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

Tracking Information
First Submitted Date  ICMJE January 15, 2013
First Posted Date  ICMJE January 28, 2013
Results First Submitted Date  ICMJE July 31, 2013
Results First Posted Date  ICMJE December 16, 2013
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • Change in Brief Pain Inventory [ Time Frame: Baseline and end of 9-week treatment protocol ]
    Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable
  • Change in Chronic Pain Acceptance Questionnaire [ Time Frame: Baseline and end of 9-week treatment protocol ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Change in Brief Pain Inventory [ Time Frame: Baseline and end of 9-week treatment protocol ]
    Intensity and Interference
  • Change in Chronic Pain Acceptance Questionnaire [ Time Frame: Baseline and end of 9-week treatment protocol ]
Change History Complete list of historical versions of study NCT01776645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Change in Brief Pain Inventory [ Time Frame: Baseline to end of 9-week treatment protocol ]
Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2013)
  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by the Hospital Anxiety and Depression Scale
  • Change in Overall Health and Well-being [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by Ryff's psychological well-being scales
  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by Neff's Self-Compassion Scale
  • Qualitative Measures [ Time Frame: Baseline and end of 9-week treatment protocol ]
    Qualitative analysis of interviews
  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As Assessed by the PROMIS Anger Scale
  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by the PROMIS Social Isolation Scale
  • Change in Overall Health and Well-being [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by PROMIS Global Health Scale
  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by Compassionate Love Scale adapted for close other
  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ]
    As assessed by Pommier's Compassion for Other's Scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Compassion Training and Pain
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain. The investigators also want to determine whether any benefit of compassion training in the patients "spreads" to significant others with whom the patient has a close relationship.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Behavioral: Compassion Cultivation Training Course
Study Arms  ICMJE Experimental: Compassion cultivation training
Intervention: Behavioral: Compassion Cultivation Training Course
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2013)
56
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
80
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18+ and chronic pain for >6months
  2. Pain over the last month
  3. Ability to read, write, and converse in English
  4. If being treated for pain condition, then stable treatment regimen.

For significant others:

1)18 years of age or older 2)Ability to read, write, and converse in English

Exclusion Criteria:

For patients and significant others:

1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher.

For patients only:

  1. prior compassion meditation experience
  2. on going legal action or disability claim
  3. currently pregnant or planning to become pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776645
Other Study ID Numbers  ICMJE 25883
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP