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Completed

NCT Number: NCT04321239

Positive Psychology for Chronic Pain Self-management

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive STEPS

Behavioral

Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They can choose to report daily step counts either by automatically syncing to an app or by manual reporting via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants will also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.

Primary outcomes

  1. Change in Pain Interference

    Time frame: Baseline and 8 weeks

    The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.

  2. Change in Self-reported Physical Functioning

    Time frame: Baseline and 8 weeks

    The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.

Secondary outcomes

  1. Participant Global Impression of Change--Pain

    Time frame: Baseline and 8 weeks

    How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.

  2. Change in Pain Self-efficacy

    Time frame: Baseline and 8 weeks

    The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident.

  3. Change in Social Participation

    Time frame: Baseline and 8 weeks

    Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.

  4. Change in Resilience

    Time frame: Baseline and 8 weeks

    10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience.

  5. Participant Global Impression of Change - Functioning

    Time frame: 8 weeks

    How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)
  • Weill Medical College of Cornell University

Registry information

Official study title

Feasibility of a Technology-Enabled Chronic Pain Self-Management Intervention Delivered by Community Health Workers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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