Chronic PainNCT01776645
Compassion Training and Pain
A study testing Compassion Cultivation Training Course in people with Chronic Pain, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Compassion Cultivation Training Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Compassion Cultivation Training Course
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Cultivation Training CourseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Compassion cultivation training | Experimental | Not described Receives: Behavioral: Compassion Cultivation Training Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and end of 9-week treatment protocol
Change in Chronic Pain Acceptance Questionnaire
Measured: Baseline and end of 9-week treatment protocol
Secondary outcomes (1)
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
Measured: Baseline to end of 9-week treatment protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776645
- Sponsor's protocol ID
- 25883
- Status last verified
- Oct 2013
- First submitted
- 15 Jan 2013
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion Training and Pain
- ClinicalTrials.gov ID
- NCT01776645
- Acronym / sponsor ID
- 25883
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Posted 16 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion cultivation training | Experimental | Behavioral: Compassion Cultivation Training Course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 1)18 years of age or older 2)Ability to read, write, and converse in English
Key exclusion criteria (6 listed)
- 1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher.
- prior compassion meditation experience
- on going legal action or disability claim
- currently pregnant or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion Cultivation Training Course | Behavioural | Compassion cultivation training |
Primary outcome
Change in Brief Pain Inventory
Time frame: 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
Time frame: Baseline and end of 9-week treatment protocol
1 secondary outcome
Change in Brief Pain Inventory
Time frame: Baseline to end of 9-week treatment protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Pain
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Cultivation Training Course in people with Chronic Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Pain Inventory (time frame: Baseline and end of 9-week treatment protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.