- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01776645
Compassion Training and Pain
October 24, 2013 updated by: Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18+ and chronic pain for >6months
- Pain over the last month
- Ability to read, write, and converse in English
- 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:
- prior compassion meditation experience
- on going legal action or disability claim
- currently pregnant or planning to become pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compassion cultivation training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and end of 9-week treatment protocol
|
|
Change in Chronic Pain Acceptance Questionnaire
Time Frame: Baseline and end of 9-week treatment protocol
|
Baseline and end of 9-week treatment protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline to end of 9-week treatment protocol
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Emotional Distress
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by the Hospital Anxiety and Depression Scale
|
Baseline and end of 9-week treatment protocol
|
|
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
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by Neff's Self-Compassion Scale
|
Baseline and end of 9-week treatment protocol
|
|
Qualitative Measures
Time Frame: Baseline and end of 9-week treatment protocol
|
Qualitative analysis of interviews
|
Baseline and end of 9-week treatment protocol
|
|
Change in Emotional Distress
Time Frame: Baseline and end of 9-week treatment protocol
|
As Assessed by the PROMIS Anger Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Emotional Distress
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by the PROMIS Social Isolation Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Overall Health and Well-being
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by PROMIS Global Health Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by Compassionate Love Scale adapted for close other
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Time Frame: Baseline and end of 9-week treatment protocol
|
As assessed by Pommier's Compassion for Other's Scale
|
Baseline and end of 9-week treatment protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 28, 2013
Study Record Updates
Last Update Posted (Estimate)
December 16, 2013
Last Update Submitted That Met QC Criteria
October 24, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25883
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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