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
  Purpose

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.


Condition Intervention
Chronic Pain
Behavioral: Compassion Cultivation Training Course

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in Brief Pain Inventory [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Brief Pain Inventory [ Time Frame: Baseline to end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes


Other Outcome Measures:
  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As assessed by Ryff's psychological well-being scales

  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    As assessed by Neff's Self-Compassion Scale

  • Qualitative Measures [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    Qualitative analysis of interviews

  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    As Assessed by the PROMIS Anger Scale

  • Change in Emotional Distress [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As assessed by PROMIS Global Health Scale

  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    As assessed by Compassionate Love Scale adapted for close other

  • Change in Compassion [ Time Frame: Baseline and end of 9-week treatment protocol ] [ Designated as safety issue: No ]
    As assessed by Pommier's Compassion for Other's Scale


Enrollment: 56
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compassion cultivation training Behavioral: Compassion Cultivation Training Course

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776645

Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
  More Information

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014