4-week Mindfulness Program for Adults With Chronic Pain

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03495856

Enrollment

Registered

2018-04-12

Start date

2018-04-23

Completion date

2018-10-26

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention

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.

Interventions

BEHAVIORALMindfulness Training For Chronic Pain

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single-group, mixed methods repeated measures design (pre and post assessments)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Feasibility - Study Retention	4 weeks	Proportion of participants enrolled who completed the study
Acceptability - Intervention Satisfaction	4 weeks (within one week post-intervention)	Question assessing participants satisfaction with the intervention
Credibility and Expectancy Questionnaire Scores	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.
Feasibility - Session Attendance	4 weeks (intervention weeks 1-4)	Average sessions attended (proportion)

Secondary

Measure	Time frame	Description
Physical Functioning Scores	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.
Pain Intensity Scores	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.
Pain Interference Scores	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.
Depression Short-Form 4a Scores	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.
Anxiety Short-Form 4a Scores	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.
Sleep Disturbance Short-Form 4a Scores	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

Measure	Time frame	Description
Positive Affect and Well-being Scores	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.
Trait Mindfulness Scores	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.
Perceived Stress Scale Scores	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.
Chronic Pain Acceptance Scores	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.
Pain Catastrophizing Scale Scores	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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
Mindfulness Training 4-week mindfulness skills group for adults with chronic pain	23
Total	23

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 23
other Total, other adverse events	1 / 23
serious Total, serious adverse events	0 / 23

Outcome results

Primary

Acceptability - Intervention Satisfaction

Question assessing participants satisfaction with the intervention

Time frame: 4 weeks (within one week post-intervention)

Population: Participants who completed the post-assessment

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mindfulness Training	Acceptability - Intervention Satisfaction	Slightly dissatisfied	1 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Neutral	1 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Slightly satisfied	1 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Very dissatisfied	0 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Moderately dissatisfied	0 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Moderately satisfied	7 Participants
Mindfulness Training	Acceptability - Intervention Satisfaction	Very satisfied	12 Participants

Primary

Credibility and Expectancy Questionnaire Scores

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.

Time frame: Intervention week 2

Population: Participants who completed the measure after session 2 (week 2)

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Credibility and Expectancy Questionnaire Scores	How logical is the mindfulness program	6.4 units on a scale	Standard Deviation 2.4
Mindfulness Training	Credibility and Expectancy Questionnaire Scores	Confidence that program will improve chronic pain	6.0 units on a scale	Standard Deviation 2.2
Mindfulness Training	Credibility and Expectancy Questionnaire Scores	Confidence in recommending program to friend	6.4 units on a scale	Standard Deviation 2.8
Mindfulness Training	Credibility and Expectancy Questionnaire Scores	How important we make this available to others	7.3 units on a scale	Standard Deviation 2.7
Mindfulness Training	Credibility and Expectancy Questionnaire Scores	Believe program would decrease other problems?	7.6 units on a scale	Standard Deviation 1.3

Primary

Feasibility - Session Attendance

Average sessions attended (proportion)

Time frame: 4 weeks (intervention weeks 1-4)

Arm	Measure	Value (MEAN)
Mindfulness Training	Feasibility - Session Attendance	0.77 Proportion of sessions

Primary

Feasibility - Study Retention

Proportion of participants enrolled who completed the study

Time frame: 4 weeks

Population: All participants who enrolled and completed the baseline assessment

Arm	Measure	Value (MEAN)
Mindfulness Training	Feasibility - Study Retention	0.96 Proportion of participants

Secondary

Anxiety Short-Form 4a Scores

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.

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Anxiety Short-Form 4a Scores	Pre	59.06 T-score	Standard Deviation 9.44
Mindfulness Training	Anxiety Short-Form 4a Scores	Post	56.84 T-score	Standard Deviation 8.02

p-value: 0.12495% CI: [-5.09, 0.66]t-test, 2 sided

Secondary

Depression Short-Form 4a Scores

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.

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Depression Short-Form 4a Scores	Pre	56.82 T-score	Standard Deviation 9.75
Mindfulness Training	Depression Short-Form 4a Scores	Post	53.49 T-score	Standard Deviation 8.62

p-value: 0.00595% CI: [-5.53, -1.15]t-test, 2 sided

Secondary

Pain Intensity Scores

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.

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

Population: Participants who completed baseline and post-assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Pain Intensity Scores	Pre	5.91 units on a scale	Standard Deviation 2.05
Mindfulness Training	Pain Intensity Scores	Post	5.14 units on a scale	Standard Deviation 1.86

p-value: 0.0595% CI: [-1.55, 0]t-test, 2 sided

Secondary

Pain Interference Scores

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.

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Pain Interference Scores	Pre	63.76 T-score	Standard Deviation 7.31
Mindfulness Training	Pain Interference Scores	Post	60.10 T-score	Standard Deviation 5.65

p-value: 0.01795% CI: [-6.63, -0.71]t-test, 2 sided

Secondary

Physical Functioning Scores

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.

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Physical Functioning Scores	Pre	38.17 T-score	Standard Deviation 5.35
Mindfulness Training	Physical Functioning Scores	Post	38.22 T-score	Standard Deviation 6.81

p-value: 0.93895% CI: [-1.39, 1.5]t-test, 2 sided

Secondary

Sleep Disturbance Short-Form 4a Scores

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.

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

Population: Participants who completed baseline and post-assessment

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Sleep Disturbance Short-Form 4a Scores	Pre	56.52 T-score	Standard Deviation 7.79
Mindfulness Training	Sleep Disturbance Short-Form 4a Scores	Post	51.83 T-score	Standard Deviation 9.75

p-value: 0.00195% CI: [-7.3, -2.07]t-test, 2 sided

Other Pre-specified

Chronic Pain Acceptance Scores

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

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Chronic Pain Acceptance Scores	Pre	57.64 score on a scale	Standard Deviation 4.22
Mindfulness Training	Chronic Pain Acceptance Scores	Post	70.91 score on a scale	Standard Deviation 4.46

p-value: <0.00195% CI: [8.47, 18.07]t-test, 2 sided

Other Pre-specified

Pain Catastrophizing Scale Scores

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

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Pain Catastrophizing Scale Scores	Pre	23.64 score on a scale	Standard Deviation 12.79
Mindfulness Training	Pain Catastrophizing Scale Scores	Post	18.68 score on a scale	Standard Deviation 12.38

p-value: 0.00295% CI: [-7.88, -2.03]t-test, 2 sided

Other Pre-specified

Perceived Stress Scale Scores

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

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Perceived Stress Scale Scores	Pre	7.23 score on a scale	Standard Deviation 3.7
Mindfulness Training	Perceived Stress Scale Scores	Post	5.95 score on a scale	Standard Deviation 3.55

p-value: 0.01895% CI: [-2.31, -0.24]t-test, 2 sided

Other Pre-specified

Positive Affect and Well-being Scores

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.

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Positive Affect and Well-being Scores	Pre	47.86 T-score	Standard Deviation 7.41
Mindfulness Training	Positive Affect and Well-being Scores	Post	50.66 T-score	Standard Deviation 7.89

p-value: 0.01695% CI: [0.58, 5.01]t-test, 2 sided

Other Pre-specified

Trait Mindfulness Scores

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

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

Population: Participants who completed baseline and post assessments

Arm	Measure	Group	Value (MEAN)	Dispersion
Mindfulness Training	Trait Mindfulness Scores	Pre	34.23 score on a scale	Standard Deviation 12.79
Mindfulness Training	Trait Mindfulness Scores	Post	42.23 score on a scale	Standard Deviation 8.1

p-value: 0.00195% CI: [3.92, 12.08]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026

4-week Mindfulness Program for Adults With Chronic Pain

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Acceptability - Intervention Satisfaction

Credibility and Expectancy Questionnaire Scores

Feasibility - Session Attendance

Feasibility - Study Retention

Anxiety Short-Form 4a Scores

Depression Short-Form 4a Scores

Pain Intensity Scores

Pain Interference Scores

Physical Functioning Scores

Sleep Disturbance Short-Form 4a Scores

Chronic Pain Acceptance Scores

Pain Catastrophizing Scale Scores

Perceived Stress Scale Scores

Positive Affect and Well-being Scores

Trait Mindfulness Scores