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Completed

NCT Number: NCT03495856

4-week Mindfulness Program for Adults With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness Training For Chronic Pain

Behavioral

4-week group Mindfulness training program for adults with chronic pain

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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