Chronic PainMBCPMNCT01886885
Mindfulness Based Chronic Pain Management: A Pilot Study
An observational study of Chronic Pain, run by University of Utah at 1 site in United States.
Trial summary
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. 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?
- Mindfulness Based Chronic Pain Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants are 18 years of age and older, English speaking, in chronic pain for 3 months or more,and willing to participate in the 13 sessions.
Who may be able to join
- 18 years of age
- English speaking
- Agree to participate
- Chronic pain for 3 months or more
Who cannot join
- Not speaking English
- Cognitive impairment
- Not able to commit to 13 week intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Mindfulness-Based Chronic Pain Management: A Pilot Study
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants. The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain. We hypothesize that participants with chronic pain will show relatively good compliance with completing the MBCPM protocol and will show increased satisfaction associated with improvement in pain-related and other psychosocial indicators of functioning.
Read the detailed description
The Institute of Medicine in their recent report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research states that: "Common chronic pain conditions affect at least 116 million U.S. adults at a cost of $560-635 billion annually in direct medical treatment costs and lost productivity." (IOM, 2011, p. 1) Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." (IASP, 2011). This widely accepted definition suggests that there are multiple components in the experience of pain, namely physiological and psychological. Pain has been reported as the most frequently reported symptom in primary care, while chronic pain is reported to affect 20-30% of the population in Western Countries. (Verhaak et al, 1998). Individuals with chronic pain often report co-morbid depression, anxiety, decreased quality of life, activity restriction, and inability to work or engage in productive activities. The most frequently used therapies are pharmacotherapy and surgical interventions, both of which have limitations in their effectiveness and tolerability.
A pressing need exists to develop alternative therapeutic modalities for caring for people with chronic pain. Mindfulness-based programs have emerged as effective interventions for different types of health conditions. Mindfulness is defined as "paying attention ina particular way, on purpose, in the present moment, and, non-judgmentally." (Kabat-Zinn, 1990) Research studies into mindfulness-based interventions have increased exponentially in the last three decades, based on the pioneering work of Jon Kabat-Zinn who developed Mindfulness-Based Stress Reduction (MBSR) in 1979. MBSR is a structured group based psycho-educational intervention that is conducted over a period of 8 weeks, with two hour classes occurring weekly. Each class teaches several mindfulness meditation practices such as sitting meditation, walking meditation, mindful yoga, and body scan. Participants are asked to complete homework assignments 6 out of 7 days following each session; these homework assignments provide opportunities to further engage in these practices so that they become more habitual. An all-day retreat occurs between weeks 6 and 7, providing further opportunities to engage in mindfulness practices.
Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD, adapted from the standard MBSR curriculum for individuals suffering from chronic pain. The focus of this intervention is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal (Garder-Nix, 2008). The adaptations made in the MBCPM curriculum were based on the needs of individuals suffering from chronic pain; they include: increasing sessions to a 13 week long curriculum, replacing the mindful yoga with more gentle stretches, allowing participants to sit, stand, lie down, or move during sessions, and shortened mindfulness meditation practices. Additional therapeutic activities are also introduced throughout the program such as guided imagery and visualization, art techniques, and information about food and sleep. The length of homework assignments is also shortened from the original one hour length in MBSR to just 5-30 minutes a day in MBCPM, and there is no all-day Saturday retreat. These adaptations were made based on observations of difficulty that participants had with the original MBSR curriculum (Gardner-Nix, 2009b). Each class is two hours long with a break in the middle.
The current literature on chronic pain suggests that existing treatments have limited utility for chronic pain sufferers. "Currently available treatments have limited effectiveness for most people with severe chronic pain. For many such individuals, pain management on a daily basis takes place outside any health care setting." (IOM, 2011, p. 13) This statement from the Institute of Medicine report underscores the reasons why people turn to complementary and alternative medicine therapies - because they are not getting adequate relief from existing more conventional treatments.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness Based Chronic Pain Management Intervention
- Keywords
- Mindfulness, Meditation, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Chronic Pain Management InterventionBehavioural
Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD for individuals suffering from chronic pain. The focus of MBCPM is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal. The activities used within MBCPM include mindfulness meditation, gentle stretching/mindful movement, guided imagery, art techniques, psychoeducation, and discussion. There are daily homework assignments of just 5-30 minutes a day in MBCPM. Each class is two hours long with a break in the middle.
| Study group | Role | What they receive |
|---|---|---|
| MBCPM | There is just one group of participants of no more than 20 people. Receives: Behavioral: Mindfulness Based Chronic Pain Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain.
The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Numerical Pain Rating Scale, Chronic Pain Acceptance Questionnaire, and the Pain Catastrophizing Scale
Measured: 6 months
Secondary outcomes (1)
The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants.
The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Center for Epidemiologic Studies Depression Scale, the Five Factor Mindfulness Scale - Short Form, and the Quality of Life Scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886885
- Sponsor's protocol ID
- IRB_00061111
- Acronym
- MBCPM
- Status last verified
- Jun 2013
- First submitted
- 5 Feb 2013
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mindfulness-Based Chronic Pain Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT01886885
- Acronym / sponsor ID
- MBCPM / IRB_00061111
- Conditions
- Chronic Pain
- Keywords
- Mindfulness, Meditation, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants. The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain. We hypothesize that participants with chronic pain will show relatively good compliance with completing the MBCPM protocol and will show increased satisfaction associated with improvement in pain-related and other psychosocial indicators of functioning.
Detailed description
The Institute of Medicine in their recent report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research states that: "Common chronic pain conditions affect at least 116 million U.S. adults at a cost of $560-635 billion annually in direct medical treatment costs and lost productivity." (IOM, 2011, p. 1) Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." (IASP, 2011). This widely accepted definition suggests that there are multiple components in the experience of pain, namely physiological and psychological. Pain has been reported as the most frequently reported symptom in primary care, while chronic pain is reported to affect 20-30% of the population in Western Countries. (Verhaak et al, 1998). Individuals with chronic pain often report co-morbid depression, anxiety, decreased quality of life, activity restriction, and inability to work or engage in productive activities. The most frequently used therapies are pharmacotherapy and surgical interventions, both of which have limitations in their effectiveness and tolerability.
A pressing need exists to develop alternative therapeutic modalities for caring for people with chronic pain. Mindfulness-based programs have emerged as effective interventions for different types of health conditions. Mindfulness is defined as "paying attention ina particular way, on purpose, in the present moment, and, non-judgmentally." (Kabat-Zinn, 1990) Research studies into mindfulness-based interventions have increased exponentially in the last three decades, based on the pioneering work of Jon Kabat-Zinn who developed Mindfulness-Based Stress Reduction (MBSR) in 1979. MBSR is a structured group based psycho-educational intervention that is conducted over a period of 8 weeks, with two hour classes occurring weekly. Each class teaches several mindfulness meditation practices such as sitting meditation, walking meditation, mindful yoga, and body scan. Participants are asked to complete homework assignments 6 out of 7 days following each session; these homework assignments provide opportunities to further engage in these practices so that they become more habitual. An all-day retreat occurs between weeks 6 and 7, providing further opportunities to engage in mindfulness practices.
Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD, adapted from the standard MBSR curriculum for individuals suffering from chronic pain. The focus of this intervention is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal (Garder-Nix, 2008). The adaptations made in the MBCPM curriculum were based on the needs of individuals suffering from chronic pain; they include: increasing sessions to a 13 week long curriculum, replacing the mindful yoga with more gentle stretches, allowing participants to sit, stand, lie down, or move during sessions, and shortened mindfulness meditation practices. Additional therapeutic activities are also introduced throughout the program such as guided imagery and visualization, art techniques, and information about food and sleep. The length of homework assignments is also shortened from the original one hour length in MBSR to just 5-30 minutes a day in MBCPM, and there is no all-day Saturday retreat. These adaptations were made based on observations of difficulty that participants had with the original MBSR curriculum (Gardner-Nix, 2009b). Each class is two hours long with a break in the middle.
The current literature on chronic pain suggests that existing treatments have limited utility for chronic pain sufferers. "Currently available treatments have limited effectiveness for most people with severe chronic pain. For many such individuals, pain management on a daily basis takes place outside any health care setting." (IOM, 2011, p. 13) This statement from the Institute of Medicine report underscores the reasons why people turn to complementary and alternative medicine therapies - because they are not getting adequate relief from existing more conventional treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCPM | – | Behavioral: Mindfulness Based Chronic Pain Management InterventionThere is just one group of participants of no more than 20 people. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are 18 years of age and older, English speaking, in chronic pain for 3 months or more,and willing to participate in the 13 sessions.
Key inclusion criteria (4 listed)
- 18 years of age
- English speaking
- Agree to participate
- Chronic pain for 3 months or more
Key exclusion criteria (3 listed)
- Not speaking English
- Cognitive impairment
- Not able to commit to 13 week intervention
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 |
|---|---|---|
| Mindfulness Based Chronic Pain Management InterventionMindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD for individuals suffering from chronic pain. The focus of MBCPM is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal. The activities used within MBCPM include mindfulness meditation, gentle stretching/mindful movement, guided imagery, art techniques, psychoeducation, and discussion. There are daily homework assignments of just 5-30 minutes a day in MBCPM. Each class is two hours long with a break in the middle. | Behavioural | MBCPM |
Primary outcome
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain.
Time frame: 6 months
The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Numerical Pain Rating Scale, Chronic Pain Acceptance Questionnaire, and the Pain Catastrophizing Scale
1 secondary outcome
The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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?
An observational study of Chronic Pain, run by University of Utah 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 4 inclusion and 3 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 8 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. (time frame: 6 months). 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 8 Nov 2023.