Clinical trial NCT03495726: Meditation for Pain
Official title: Mindfulness for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Contemplative
Applications
Well-being
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. All participants will be asked to complete a set of questionnaires

Detailed description: Chronic pain affects an estimated 11.2% of the US population, costs the United States approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. Understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. However, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (Apps) for Well-being (CAWs). The proposed study will examine the use and impact of a meditation apps in the context of pain. Participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. To assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.

Eligibility criteria: Inclusion Criteria:

* Emory Healthcare patient

Exclusion Criteria:

* Non-english speaking patients
* Children, prisoners or other vulnerable populations

Primary outcomes:
measure: Change in Pain Catastrophizing Scale Score
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Brief Pain Inventory
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Current Opioid Misuse Measure (COMM) Score
timeFrame: Baseline, Week 3, Week 6, Week 14
Secondary outcomes:
measure: Change in Physical Functioning Subscale (PF-10) Score
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Basel Assessment of Adherence Immunosuppression Scale Score
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Depression Anxiety and Stress Scale (DASS) Score
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Brief Coping with Problems Experienced (COPE) Inventory
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Social Functioning - Short Form Score
timeFrame: Baseline, Week 3, Week 6, Week 14
measure: Change in PROMIS Loneliness - Fixed Form Score
timeFrame: Baseline, Week 3, Week 6, Week 14
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jennifer Mascaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: