Positive Psychology for Chronic Pain Self-management

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Positive STEPS

• Registration Number: NCT04321239
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-05-14
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Results First Submitted: 2021-08-31
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Results First Posted: 2021-11-01
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Positive STEPS	Participants will engage in a 7-week positive psychology-based chronic pain self-management program.

Primary Outcome Measures

Name	Time	Method
Change in Pain Interference	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.
Change in Self-reported Physical Functioning	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 Outcome Measures

Name	Time	Method
Participant Global Impression of Change--Pain	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.
Change in Pain Self-efficacy	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.
Change in Social Participation	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.
Change in Resilience	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.
Participant Global Impression of Change - Functioning	8 weeks	How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States