Chronic Pain
Conditions
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.
Interventions
BEHAVIORALCompassion Cultivation Training Course
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory | 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 |
| Change in Chronic Pain Acceptance Questionnaire | Baseline and end of 9-week treatment protocol | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotional Distress | Baseline and end of 9-week treatment protocol | As assessed by the Hospital Anxiety and Depression Scale |
| Qualitative Measures | Baseline and end of 9-week treatment protocol | Qualitative analysis of interviews |
| Change in Overall Health and Well-being | Baseline and end of 9-week treatment protocol | As assessed by Ryff's psychological well-being scales |
| Change in Compassion | Baseline and end of 9-week treatment protocol | As assessed by Neff's Self-Compassion Scale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Compassion Cultivation Training - Participants With Chronic Pa Compassion Cultivation Training Course - Participants with Chronic Pain | 28 |
| Significant Others Group Significant Others of Participants with Chronic Pain | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Significant Others Group | Compassion Cultivation Training - Participants With Chronic Pa | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Age Continuous | 50.71 years STANDARD_DEVIATION 12.59 | 49.61 years STANDARD_DEVIATION 10.59 | 50.16 years STANDARD_DEVIATION 11.75 |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 7 Participants | 24 Participants | 31 Participants |
| Sex: Female, Male Male | 21 Participants | 4 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
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
Time frame: Baseline and end of 9-week treatment protocol
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Cultivation Training | Change in Brief Pain Inventory | -1.46 units on a scale | Standard Deviation 1.29 |
Primary
Change in Chronic Pain Acceptance Questionnaire
Time frame: 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
Time frame: Baseline to end of 9-week treatment protocol
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassion Cultivation Training | Change in Brief Pain Inventory | -1.18 units on a scale | Standard Deviation 1.94 |
Other Pre-specified
Change in Compassion
As assessed by Neff's Self-Compassion Scale
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Change in Compassion
As assessed by Pommier's Compassion for Other's Scale
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Change in Compassion
As assessed by Compassionate Love Scale adapted for close other
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Change in Emotional Distress
As assessed by the Hospital Anxiety and Depression Scale
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Change in Emotional Distress
As Assessed by the PROMIS Anger Scale
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Change in Emotional Distress
As assessed by the PROMIS Social Isolation Scale
Time frame: 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
Time frame: 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
Time frame: Baseline and end of 9-week treatment protocol
Other Pre-specified
Qualitative Measures
Qualitative analysis of interviews
Time frame: Baseline and end of 9-week treatment protocol