Clinical trial NCT04321239: Positive Psychology for Chronic Pain Self-management
Official title: Feasibility of a Technology-Enabled Chronic Pain Self-Management Intervention Delivered by Community Health Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Weill Medical College of Cornell University
First posted: 2020-03-25
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a randomized pilot and feasibility trial of a positive psychology-based chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 50 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility criteria: Inclusion Criteria:

* English-proficient
* Ambulatory with or without assistive device
* Community-living
* Have a cell or landline phone
* Have Internet access (home or elsewhere);
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities.

Exclusion Criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next three months
* Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit

Primary outcomes:
measure: Change in Pain Interference
timeFrame: Baseline and 8 weeks
measure: Change in Self-reported Physical Functioning
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Participant Global Impression of Change--Pain
timeFrame: Baseline and 8 weeks
measure: Change in Pain Self-efficacy
timeFrame: Baseline and 8 weeks
measure: Change in Social Participation
timeFrame: Baseline and 8 weeks
measure: Change in Resilience
timeFrame: Baseline and 8 weeks
measure: Participant Global Impression of Change - Functioning
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mary Janevic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janevic M, Robinson-Lane SG, Courser R, Brines E, Hassett AL. A Community Health Worker-Led Positive Psychology Intervention for African American Older Adults With Chronic Pain. Gerontologist. 2022 Oct 19;62(9):1369-1380. doi: 10.1093/geront/gnac010.