NCT01776645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 16, 2013

Completed
Last Updated

December 16, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

January 15, 2013

Results QC Date

July 31, 2013

Last Update Submit

October 24, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline and end of 9-week treatment protocol

  • Change in Chronic Pain Acceptance Questionnaire

    Baseline and end of 9-week treatment protocol

Secondary Outcomes (1)

  • Change in Brief Pain Inventory

    Baseline to end of 9-week treatment protocol

Other Outcomes (9)

  • Change in Emotional Distress

    Baseline and end of 9-week treatment protocol

  • Change in Overall Health and Well-being

    Baseline and end of 9-week treatment protocol

  • Change in Compassion

    Baseline and end of 9-week treatment protocol

  • +6 more other outcomes

Study Arms (1)

Compassion cultivation training

EXPERIMENTAL
Behavioral: Compassion Cultivation Training Course

Interventions

Compassion cultivation training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • For patients and significant others:
  • )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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Sean Mackey
Organization
Stanford University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 28, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 16, 2013

Results First Posted

December 16, 2013

Record last verified: 2013-10

Locations