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4-week Mindfulness Program for Adults With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495856
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The objective of this study is to determine the feasibility and acceptability of a 4-week mindfulness training program for adults with chronic pain (noncancer related). The intervention is based on the MIndfulness-based Stress Reduction Program, an 8-week mindfulness training program developed to help people manage stress-related and chronic conditions. The adapted mindfulness intervention will consist of four, weekly 1 hour and 30 minute group sessions that are modified from the original program to fit the shorter length and to directly address chronic pain management. Participants will complete pre- and post-intervention surveys and daily mindfulness practice diaries, all online. The surveys will help us determine if participants experience decreased pain interference, increased quality-of-life, and increased psychological well-being over the course of the intervention. Participants will also complete a post-intervention telephone interview to help determine satisfaction with the intervention and areas where the intervention can be improved.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Mindfulness Training For Chronic Pain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-group, mixed methods repeated measures design (pre and post assessments)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Mindfulness Training For Chronic Pain
The intervention is adapted from the mindfulness-based stress reduction program. The adapted mindfulness training program consists of four, weekly 90 minute group sessions that focus on education on chronic pain and mindfulness, instruction and in-class mindfulness skills practice, and group discussion.
Behavioral: Mindfulness Training For Chronic Pain
4-week group Mindfulness training program for adults with chronic pain




Primary Outcome Measures :
  1. Feasibility - Study Retention [ Time Frame: 4 weeks ]
    Proportion of participants enrolled who completed the study

  2. Feasibility - Session Attendance [ Time Frame: 4 weeks (intervention weeks 1-4) ]
    Average sessions attended (proportion)

  3. Credibility and Expectancy Questionnaire Scores [ Time Frame: Intervention week 2 ]
    Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 [not at all] to 10 [very]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.

  4. Acceptability - Intervention Satisfaction [ Time Frame: 4 weeks (within one week post-intervention) ]
    Question assessing participants satisfaction with the intervention


Secondary Outcome Measures :
  1. Pain Intensity Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.

  2. Pain Interference Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome.

  3. Physical Functioning Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome.

  4. Depression Short-Form 4a Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome.

  5. Anxiety Short-Form 4a Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome.

  6. Sleep Disturbance Short-Form 4a Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome.


Other Outcome Measures:
  1. Perceived Stress Scale Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.

  2. Positive Affect and Well-being Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.

  3. Pain Catastrophizing Scale Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.

  4. Chronic Pain Acceptance Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.

  5. Trait Mindfulness Scores [ Time Frame: Baseline and 4 weeks (pre to post-intervention) ]
    Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One or more chronic noncancer pain diagnoses (daily pain for at least 3 months)
  • Has a pain management provider
  • Reports more than minimal pain bothersomeness and interference in general activities
  • Able to read and understand English

Exclusion Criteria:

  • Diagnosis of mental illness with psychotic features
  • History of inpatient admission for psychiatric disorder in past 2 years
  • Active alcohol or substance abuse within the past year
  • Has completed a mindfulness-based stress reduction or other mindfulness course; has or previously had a regular mindfulness meditation practice.
  • Unable or unwilling to comply with study procedures (online questionnaires and practice diaries, 4 weekly intervention sessions, home practice, and one semi-structured phone interview).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495856


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Carrie Brintz, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03495856    
Other Study ID Numbers: 17-2948
2KR941702 ( Other Grant/Funding Number: North Carolina Translational and Clinical Sciences Institute )
First Posted: April 12, 2018    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Mindfulness-based stress reduction
Mindfulness
chronic pain
Feasibility
Intervention
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms