Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Pain Clinical Trial

Official title:

Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387290
• Other study ID #: 00172836
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: May 1, 2030

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Thanusha Puvananayagam, MPH
• Phone: 732-235-4341
• Email: puvanath[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 +

• Current chronic pain diagnosis (pain for =3 months) determined by physician assessment

• Current use of opioids for =3 months

• Score >=3 on the Pain Enjoyment General Activity scale

• Score >=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR physician determination that risks of opioid use may outweigh the benefits of opioid use

Exclusion Criteria:

• Chronic pain due to a cancer diagnosis

• Active suicidal intent, schizophrenia, psychotic disorder

• Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement

Related Conditions & MeSH terms

• Chemically-Induced Disorders
• Chronic Pain
• Mental Disorders
• Neurologic Manifestations
• Opioid-Related Disorders
• Pain
• Prescription Opioid Misuse
• Substance-Related Disorders

Intervention

Behavioral:
• Mindfulness Oriented Recovery Enhancement
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative therapeutic approach.
• Patient-Centered Chronic Pain Management Visits
Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics).

Locations

Country	Name	City	State
United States	Rutgers University Primary Care Clinics	New Brunswick	New Jersey
United States	University of Utah Primary Care Clinics	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decentering	Change in Decentering from baseline through study completion will be measured with the Metacognitive Processes of Decentering (MPODS) scale. Scores range from 15 to 75, with higher scores indicating more decentering.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Other	Mindful Reappraisal of Pain Sensations	Change in Mindful Reappraisal of Pain Sensations from baseline through study completion will be assessed with the Mindful Reappraisal of Pain Sensations (MRPS) Scale. Scores range from 0 to 54, with higher scores indicating greater mindful reappraisal of pain sensations.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Other	Savoring	Change in savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Other	Reappraisal	Change in reappraisal measured by the Emotion Regulation Questionnaire, range from 6 to 42, with a higher score indicating more use of reappraisal.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Primary	Opioid Misuse	Opioid misuse as evidenced by triangulated aggregate of self-reported Current Opioid Misuse Measure and/or interview via Addiction Behaviors Checklist and/or urine screen	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Primary	Chronic Pain	Change in Chronic pain will be measured from baseline through study completion using the Pain, Enjoyment of Life, and General Activity Scale (PEG). Scoring can be determined in one of two ways: A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities; Dividing the sum of responses to all three items by 3 to get the mean score on a scale of 0-10, with higher scores indicating more severe pain and pain-related interference with life and activities.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary	Change in Quality of Life	Change in Quality of Life will be measured from baseline through study completion using the Patient Reported Outcomes Measurement Information System (PROMIS-29) to assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores range from 4-20 in each domain, with higher scores indicating more impairment in that domain.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary	Opioid Dosing	Opioid dose will be assessed from baseline through study completion by Timeline Follow Back (TLFB) interview. Opioid dose will be converted to morphine-equivalent using equianalgesic conversions.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary	Opioid Craving	Opioid craving will be assessed with validated numeric rating scale items (Garland et. al, 2022) delivered by ecological momentary assessment.	Daily from baseline through month 4
Secondary	PTSD Symptoms	PTSD Symptoms will be measured from baseline through study completion using the Posttraumatic Stress Disorder Checklist (PCL-5). Scores range from 0-80, with higher scores indicating overall higher PTSD symptom severity.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary	Depression	Depression symptoms will be measured from baseline through study completion using the nine-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more severe symptoms of depression.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Secondary	Generalized Anxiety	Generalized Anxiety will be measured from baseline through study completion using the Generalized Anxiety Disorder 7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe symptoms of anxiety.	Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)