Trial Outcomes & Findings for 4-week Mindfulness Program for Adults With Chronic Pain (NCT NCT03495856)

NCT ID: NCT03495856

Last Updated: 2019-09-09

Results Overview

Proportion of participants enrolled who completed the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-09-09

Participant Flow

Recruitment Dates: April 2018 to September 2018 Recruitment Setting: Medical clinics; University/Medical center campus and email listserve

Participant milestones

Measure	Mindfulness Training 4-week mindfulness skills group for adults with chronic pain
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

4-week Mindfulness Program for Adults With Chronic Pain

Baseline characteristics by cohort

Measure	Mindfulness Training n=23 Participants 4-week mindfulness skills group for adults with chronic pain
Age, Continuous	53.00 years STANDARD_DEVIATION 15.58 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants
Years with chronic pain	6.9 years STANDARD_DEVIATION 7.2 • n=5 Participants
Education Less than high school	0 Participants n=5 Participants
Education High School diploma or equivalent	1 Participants n=5 Participants
Education Some college, no college degree	5 Participants n=5 Participants
Education College degree or greater	16 Participants n=5 Participants
Education Unknown	1 Participants n=5 Participants
Yearly Household Income Less than $20,000	5 Participants n=5 Participants
Yearly Household Income $20,000 to 39,999	2 Participants n=5 Participants
Yearly Household Income $40,000 to $59,999	4 Participants n=5 Participants
Yearly Household Income $60,000 to $79,999	2 Participants n=5 Participants
Yearly Household Income $80,000 +	8 Participants n=5 Participants
Yearly Household Income Unknown	2 Participants n=5 Participants
Source/location of pain Back	18 Participants n=5 Participants
Source/location of pain Arthritis	11 Participants n=5 Participants
Source/location of pain Fibromyalgia	4 Participants n=5 Participants
Source/location of pain Neck	12 Participants n=5 Participants
Source/location of pain Neuropathy	11 Participants n=5 Participants
Source/location of pain Headache/migraine	7 Participants n=5 Participants
Source/location of pain Pelvic	4 Participants n=5 Participants
Source/location of pain Other	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All participants who enrolled and completed the baseline assessment

Proportion of participants enrolled who completed the study

Outcome measures

Measure	Mindfulness Training n=23 Participants 4-week mindfulness skills group for adults with chronic pain
Feasibility - Study Retention	0.96 Proportion of participants Interval 0.87 to 1.04

PRIMARY outcome

Timeframe: 4 weeks (intervention weeks 1-4)

Average sessions attended (proportion)

Outcome measures

Measure	Mindfulness Training n=23 Participants 4-week mindfulness skills group for adults with chronic pain
Feasibility - Session Attendance	0.77 Proportion of sessions Interval 0.58 to 0.96

PRIMARY outcome

Timeframe: Intervention week 2

Population: Participants who completed the measure after session 2 (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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Credibility and Expectancy Questionnaire Scores How logical is the mindfulness program	6.4 units on a scale Standard Deviation 2.4
Credibility and Expectancy Questionnaire Scores Confidence that program will improve chronic pain	6.0 units on a scale Standard Deviation 2.2
Credibility and Expectancy Questionnaire Scores Confidence in recommending program to friend	6.4 units on a scale Standard Deviation 2.8
Credibility and Expectancy Questionnaire Scores How important we make this available to others	7.3 units on a scale Standard Deviation 2.7
Credibility and Expectancy Questionnaire Scores Believe program would decrease other problems?	7.6 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 4 weeks (within one week post-intervention)

Population: Participants who completed the post-assessment

Question assessing participants satisfaction with the intervention

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Acceptability - Intervention Satisfaction Very dissatisfied	0 Participants
Acceptability - Intervention Satisfaction Moderately dissatisfied	0 Participants
Acceptability - Intervention Satisfaction Slightly dissatisfied	1 Participants
Acceptability - Intervention Satisfaction Neutral	1 Participants
Acceptability - Intervention Satisfaction Slightly satisfied	1 Participants
Acceptability - Intervention Satisfaction Moderately satisfied	7 Participants
Acceptability - Intervention Satisfaction Very satisfied	12 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post-assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Pain Intensity Scores Pre	5.91 units on a scale Standard Deviation 2.05
Pain Intensity Scores Post	5.14 units on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Pain Interference Scores Pre	63.76 T-score Standard Deviation 7.31
Pain Interference Scores Post	60.10 T-score Standard Deviation 5.65

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Physical Functioning Scores Pre	38.17 T-score Standard Deviation 5.35
Physical Functioning Scores Post	38.22 T-score Standard Deviation 6.81

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Depression Short-Form 4a Scores Pre	56.82 T-score Standard Deviation 9.75
Depression Short-Form 4a Scores Post	53.49 T-score Standard Deviation 8.62

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Anxiety Short-Form 4a Scores Pre	59.06 T-score Standard Deviation 9.44
Anxiety Short-Form 4a Scores Post	56.84 T-score Standard Deviation 8.02

SECONDARY outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post-assessment

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Sleep Disturbance Short-Form 4a Scores Pre	56.52 T-score Standard Deviation 7.79
Sleep Disturbance Short-Form 4a Scores Post	51.83 T-score Standard Deviation 9.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Perceived Stress Scale Scores Pre	7.23 score on a scale Standard Deviation 3.70
Perceived Stress Scale Scores Post	5.95 score on a scale Standard Deviation 3.55

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

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.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Positive Affect and Well-being Scores Pre	47.86 T-score Standard Deviation 7.41
Positive Affect and Well-being Scores Post	50.66 T-score Standard Deviation 7.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Pain Catastrophizing Scale Scores Pre	23.64 score on a scale Standard Deviation 12.79
Pain Catastrophizing Scale Scores Post	18.68 score on a scale Standard Deviation 12.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Chronic Pain Acceptance Scores Pre	57.64 score on a scale Standard Deviation 4.22
Chronic Pain Acceptance Scores Post	70.91 score on a scale Standard Deviation 4.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (pre to post-intervention)

Population: Participants who completed baseline and post assessments

Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.

Outcome measures

Measure	Mindfulness Training n=22 Participants 4-week mindfulness skills group for adults with chronic pain
Trait Mindfulness Scores Pre	34.23 score on a scale Standard Deviation 12.79
Trait Mindfulness Scores Post	42.23 score on a scale Standard Deviation 8.10

Adverse Events

Mindfulness Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mindfulness Training n=23 participants at risk 4-week mindfulness skills group for adults with chronic pain
Psychiatric disorders Distress due to potential for dissociating	4.3% 1/23 • Number of events 1 • 4 weeks (session 1 through session 4)

Additional Information

Carrie Brintz

University of North Carolina School of Medicine

Phone: 919-445-6109

Email: carrie_brintz@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place