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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compassion cultivation training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compassion Cultivation Training Course | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Distress | As assessed by the Hospital Anxiety and Depression Scale | Baseline and end of 9-week treatment protocol |
| Change in Overall Health and Well-being | As assessed by Ryff's psychological well-being scales |
Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Compassion Cultivation Training | Compassion Cultivation Training Course - Participants with Chronic Pain |
| FG001 | Significant Others Group | Significant others of the individuals with chronic pain undergoing the compassion cultivation training course |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Compassion Cultivation Training - Participants With Chronic Pa | Compassion Cultivation Training Course - Participants with Chronic Pain |
| BG001 | Significant Others Group | Significant Others of Participants with Chronic Pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain | Posted | Mean | Standard Deviation | units on a scale | Baseline and end of 9-week treatment protocol |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Compassion Cultivation Training | Compassion Cultivation Training Course - Participants with Chronic Pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean Mackey | Stanford University | 650-724-2795 | smackey@pain.stanford.edu |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline and end of 9-week treatment protocol |
| Change in Compassion | As assessed by Neff's Self-Compassion Scale | Baseline and end of 9-week treatment protocol |
| Qualitative Measures | Qualitative analysis of interviews | Baseline and end of 9-week treatment protocol |
| Change in Emotional Distress | As Assessed by the PROMIS Anger Scale | Baseline and end of 9-week treatment protocol |
| Change in Emotional Distress | As assessed by the PROMIS Social Isolation Scale | Baseline and end of 9-week treatment protocol |
| Change in Overall Health and Well-being | As assessed by PROMIS Global Health Scale | Baseline and end of 9-week treatment protocol |
| Change in Compassion | As assessed by Compassionate Love Scale adapted for close other | Baseline and end of 9-week treatment protocol |
| Change in Compassion | As assessed by Pommier's Compassion for Other's Scale | Baseline and end of 9-week treatment protocol |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Change in Chronic Pain Acceptance Questionnaire | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Emotional Distress | As assessed by the Hospital Anxiety and Depression Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Overall Health and Well-being | As assessed by Ryff's psychological well-being scales | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Compassion | As assessed by Neff's Self-Compassion Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Qualitative Measures | Qualitative analysis of interviews | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Emotional Distress | As Assessed by the PROMIS Anger Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Emotional Distress | As assessed by the PROMIS Social Isolation Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Overall Health and Well-being | As assessed by PROMIS Global Health Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Compassion | As assessed by Compassionate Love Scale adapted for close other | Not Posted | Baseline and end of 9-week treatment protocol |
| Other Pre-specified | Change in Compassion | As assessed by Pommier's Compassion for Other's Scale | Not Posted | Baseline and end of 9-week treatment protocol |
| 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 | 2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain | Posted | Mean | Standard Deviation | units on a scale | Baseline to end of 9-week treatment protocol |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Significant Others Group | Significant others of the individuals with chronic pain undergoing the compassion cultivation training course | 0 | 28 | 0 | 28 |
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