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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01776645
Other study ID # 25883
Secondary ID
Status Completed
Phase N/A
First received January 15, 2013
Last updated October 24, 2013
Start date January 2013
Est. completion date May 2013

Study information

Verified date October 2013
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Compassion Cultivation Training Course


Locations

Country Name City State
United States Stanford University School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Emotional Distress As assessed by the Hospital Anxiety and Depression Scale Baseline and end of 9-week treatment protocol No
Other Change in Overall Health and Well-being As assessed by Ryff's psychological well-being scales Baseline and end of 9-week treatment protocol No
Other Change in Compassion As assessed by Neff's Self-Compassion Scale Baseline and end of 9-week treatment protocol No
Other Qualitative Measures Qualitative analysis of interviews Baseline and end of 9-week treatment protocol No
Other Change in Emotional Distress As Assessed by the PROMIS Anger Scale Baseline and end of 9-week treatment protocol No
Other Change in Emotional Distress As assessed by the PROMIS Social Isolation Scale Baseline and end of 9-week treatment protocol No
Other Change in Overall Health and Well-being As assessed by PROMIS Global Health Scale Baseline and end of 9-week treatment protocol No
Other Change in Compassion As assessed by Compassionate Love Scale adapted for close other Baseline and end of 9-week treatment protocol No
Other Change in Compassion As assessed by Pommier's Compassion for Other's Scale Baseline and end of 9-week treatment protocol No
Primary 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 No
Primary Change in Chronic Pain Acceptance Questionnaire Baseline and end of 9-week treatment protocol No
Secondary 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 Baseline to end of 9-week treatment protocol No
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