NCT03495856

4-week Mindfulness Program for Adults With Chronic Pain

Completed NA Results posted Last updated 9 September 2019

What this trial tests

NA trial testing Mindfulness Training For Chronic Pain in Chronic Pain in 23 participants. Completed in 26 October 2018.

Timeline

23 April 2018

Primary endpoint
26 October 2018

26 October 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	23 April 2018
Primary completion	26 October 2018
Estimated completion	26 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness Training For Chronic Pain

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility - Study Retention Primary · 4 weeks

Proportion of participants enrolled who completed the study

Group	Value	95% CI
Mindfulness Training	0.96	0.87 – 1.04

Feasibility - Session Attendance Primary · 4 weeks (intervention weeks 1-4)

Average sessions attended (proportion)

Group	Value	95% CI
Mindfulness Training	0.77	0.58 – 0.96

Credibility and Expectancy Questionnaire Scores Primary · 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.

How logical is the mindfulness program

Group	Value	95% CI
Mindfulness Training	6.4	± 2.4

Confidence that program will improve chronic pain

Group	Value	95% CI
Mindfulness Training	6.0	± 2.2

Confidence in recommending program to friend

Group	Value	95% CI
Mindfulness Training	6.4	± 2.8

How important we make this available to others

Group	Value	95% CI
Mindfulness Training	7.3	± 2.7

Believe program would decrease other problems?

Group	Value	95% CI
Mindfulness Training	7.6	± 1.3

Acceptability - Intervention Satisfaction Primary · 4 weeks (within one week post-intervention)

Question assessing participants satisfaction with the intervention

Group	Value	95% CI
Mindfulness Training	0
Mindfulness Training	0
Mindfulness Training	1
Mindfulness Training	1

Pain Intensity Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	5.91	± 2.05

Post

Group	Value	95% CI
Mindfulness Training	5.14	± 1.86

Pain Interference Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	63.76	± 7.31

Post

Group	Value	95% CI
Mindfulness Training	60.10	± 5.65

Physical Functioning Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	38.17	± 5.35

Post

Group	Value	95% CI
Mindfulness Training	38.22	± 6.81

Depression Short-Form 4a Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	56.82	± 9.75

Post

Group	Value	95% CI
Mindfulness Training	53.49	± 8.62

Anxiety Short-Form 4a Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	59.06	± 9.44

Post

Group	Value	95% CI
Mindfulness Training	56.84	± 8.02

Sleep Disturbance Short-Form 4a Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	56.52	± 7.79

Post

Group	Value	95% CI
Mindfulness Training	51.83	± 9.75

Perceived Stress Scale Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	7.23	± 3.70

Post

Group	Value	95% CI
Mindfulness Training	5.95	± 3.55

Positive Affect and Well-being Scores Secondary · 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.

Pre

Group	Value	95% CI
Mindfulness Training	47.86	± 7.41

Post

Group	Value	95% CI
Mindfulness Training	50.66	± 7.89

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks (session 1 through session 4). Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness Training

Serious: 0/23 (0%)

Deaths: 0/23

Other adverse events (1 terms — click to expand)

Reaction	System	Mindfulness Training
Distress due to potential for dissociating	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT03495856 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Are Formal and Informal Home Mindfulness Practice Quantities Associated With Outcomes? Results From a Pilot Study of a Four-Week Mindfulness Intervention for Chronic Pain Management.
   Brintz CE, Polser G, Coronado RA, French B, et al · · 2024 · cited 4× · PMID 38434590 · DOI 10.1177/27536130241236775