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Compassion Training and Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassion Cultivation Training Course
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compassion cultivation training

Arm Description

Outcomes

Primary Outcome Measures

Change in Brief Pain Inventory
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

Secondary Outcome Measures

Change in Brief Pain Inventory
Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes

Full Information

First Posted
January 15, 2013
Last Updated
October 24, 2013
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01776645
Brief Title
Compassion Training and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion cultivation training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Compassion Cultivation Training Course
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory
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
Title
Change in Chronic Pain Acceptance Questionnaire
Time Frame
Baseline and end of 9-week treatment protocol
Secondary Outcome Measure Information:
Title
Change in Brief Pain Inventory
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
Other Pre-specified Outcome Measures:
Title
Change in Emotional Distress
Description
As assessed by the Hospital Anxiety and Depression Scale
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Overall Health and Well-being
Description
As assessed by Ryff's psychological well-being scales
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Compassion
Description
As assessed by Neff's Self-Compassion Scale
Time Frame
Baseline and end of 9-week treatment protocol
Title
Qualitative Measures
Description
Qualitative analysis of interviews
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Emotional Distress
Description
As Assessed by the PROMIS Anger Scale
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Emotional Distress
Description
As assessed by the PROMIS Social Isolation Scale
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Overall Health and Well-being
Description
As assessed by PROMIS Global Health Scale
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Compassion
Description
As assessed by Compassionate Love Scale adapted for close other
Time Frame
Baseline and end of 9-week treatment protocol
Title
Change in Compassion
Description
As assessed by Pommier's Compassion for Other's Scale
Time Frame
Baseline and end of 9-week treatment protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Compassion Training and Pain

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