4-week Mindfulness Program for Adults With Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495856
• Other study ID #: 17-2948
• Secondary ID: 2KR941702
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: October 26, 2018

Study information

• Verified date: March 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mindfulness Training For Chronic Pain
4-week group Mindfulness training program for adults with chronic pain

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline and 4 weeks (pre to post-intervention)
Other	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.	Baseline and 4 weeks (pre to post-intervention)
Other	Pain Catastrophizing Scale Scores	Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.	Baseline and 4 weeks (pre to post-intervention)
Other	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.	Baseline and 4 weeks (pre to post-intervention)
Other	Trait Mindfulness Scores	Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.	Baseline and 4 weeks (pre to post-intervention)
Primary	Feasibility - Study Retention	Proportion of participants enrolled who completed the study	4 weeks
Primary	Feasibility - Session Attendance	Average sessions attended (proportion)	4 weeks (intervention weeks 1-4)
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.	Intervention week 2
Primary	Acceptability - Intervention Satisfaction	Question assessing participants satisfaction with the intervention	4 weeks (within one week post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)
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.	Baseline and 4 weeks (pre to post-intervention)