Chronic PainNCT03495856

4-week Mindfulness Program for Adults With Chronic Pain

A study testing Mindfulness Training For Chronic Pain in people with Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Mindfulness Training For Chronic Pain
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 23 Apr 2018to 26 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Feasibility of a 4-week, Adapted 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.

Conditions: Chronic Pain
Being tested: Mindfulness Training For Chronic Pain
Keywords: Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness Training For Chronic PainBehavioural
4-week group Mindfulness training program for adults with chronic pain

Study groups in NCT03495856
Study group	Role	What they receive
Mindfulness Training For Chronic Pain	Experimental	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. Receives: Behavioral: Mindfulness Training For Chronic Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Study Retention
Proportion of participants enrolled who completed the study
Measured: 4 weeks
Feasibility - Session Attendance
Average sessions attended (proportion)
Measured: 4 weeks (intervention weeks 1-4)
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.
Measured: Intervention week 2
Acceptability - Intervention Satisfaction
Question assessing participants satisfaction with the intervention
Measured: 4 weeks (within one week post-intervention)

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201826 Oct 2018

First posted12 Apr 2018
Study start23 Apr 2018
Primary completion26 Oct 2018
Study completion26 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single-group, mixed methods repeated measures design (pre and post assessments)
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03495856
Sponsor's protocol ID: 17-2948
Other IDs: 2KR941702
Status last verified: Mar 2019
First submitted: 21 Mar 2018
Last updated: 9 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Brintz CE, Polser G, Coronado RA, French B, Faurot KR, Gaylord SA. 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. Glob Adv Integr Med Health. 2024 Feb 29;13:27536130241236775. doi: 10.1177/27536130241236775. eCollection 2024 Jan-Dec.
PubMed 38434590

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain
ClinicalTrials.gov ID: NCT03495856
Acronym / sponsor ID: 17-2948
Conditions: Chronic Pain
Keywords: Mindfulness-based stress reduction, Mindfulness, chronic pain, Feasibility, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: North Carolina Translational and Clinical Sciences Institute
Study start: 23 Apr 2018 (actual)
Primary completion: 26 Oct 2018 (actual)
Study completion: 26 Oct 2018 (actual)
First posted: 12 Apr 2018 (actual)
Results: Posted 9 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-group, mixed methods repeated measures design (pre and post assessments)

Arm	Type	Receives
Mindfulness Training For Chronic Pain	Experimental	Behavioral: Mindfulness Training For Chronic PainThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness Training For Chronic Pain4-week group Mindfulness training program for adults with chronic pain	Behavioural	Mindfulness Training For Chronic Pain

Primary outcome

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

6 secondary outcomes

Pain Intensity Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)
Pain Interference Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)
Physical Functioning Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)
Depression Short-Form 4a Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)
Anxiety Short-Form 4a Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)
Sleep Disturbance Short-Form 4a Scores
Time frame: Baseline and 4 weeks (pre to post-intervention)

Results and safety

Results posted to the registry on 9 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness Training	23	22

Primary outcome: Feasibility - Study Retention

Time frame: 4 weeks. Mean (95% Confidence Interval). Unit: Proportion of participants

Measure	Mindfulness Training n = 23
Value	0.96 (0.87 to 1.04)

Population analysed: All participants who enrolled and completed the baseline assessment

Primary outcome: Feasibility - Session Attendance

Time frame: 4 weeks (intervention weeks 1-4). Mean (95% Confidence Interval). Unit: Proportion of sessions

Measure	Mindfulness Training n = 23
Value	0.77 (0.58 to 0.96)

Primary outcome: Credibility and Expectancy Questionnaire Scores

Time frame: Intervention week 2. Mean (Standard Deviation). Unit: units on a scale

Measure	Mindfulness Training n = 22
How logical is the mindfulness program	6.4 (2.4)
Confidence that program will improve chronic pain	6.0 (2.2)
Confidence in recommending program to friend	6.4 (2.8)
How important we make this available to others	7.3 (2.7)
Believe program would decrease other problems?	7.6 (1.3)

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

Primary outcome: Acceptability - Intervention Satisfaction

Time frame: 4 weeks (within one week post-intervention). Count of participants. Unit: Participants

Measure	Mindfulness Training n = 22
Very dissatisfied	0
Moderately dissatisfied	0
Slightly dissatisfied	1
Neutral	1
Slightly satisfied	1
Moderately satisfied	7
Very satisfied	12

Population analysed: Participants who completed the post-assessment

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks (session 1 through session 4). Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Training	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38434590Brintz CE, Polser G, Coronado RA, French B, Faurot KR, Gaylord SA. 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. Glob Adv Integr Med Health. 2024 Feb 29;13:27536130241236775. doi: 10.1177/27536130241236775. eCollection 2024 Jan-Dec.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carrie Brintz, PhD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Training For Chronic Pain in people with Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Study Retention (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.