NCT04321239

Positive Psychology for Chronic Pain Self-management

Completed NA Results posted Last updated 1 November 2021

What this trial tests

NA trial testing Positive STEPS in Chronic Pain in 51 participants. Completed in 22 December 2020.

Timeline

14 May 2020

Primary endpoint
22 December 2020

22 December 2020

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	14 May 2020
Primary completion	22 December 2020
Estimated completion	22 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Positive STEPS

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of Michigan

Who can join

60 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Interference Primary · 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.

Group	Value	95% CI
Intervention Group	-3.82	± 5.2
Usual Care Control Group	.32	± 5.0

Change in Self-reported Physical Functioning Primary · 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.

Group	Value	95% CI
Intervention Group	43.7	± 7.7
Usual Care Control Group	40.9	± 6.3

Participant Global Impression of Change--Pain Secondary · 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.

Group	Value	95% CI
Intervention Group	6.1	± .97
Usual Care Control Group	4.4	± 1.3

Change in Pain Self-efficacy Secondary · 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.

Group	Value	95% CI
Intervention Group	.36	± .91
Usual Care Control Group	-.16	± .71

Change in Social Participation Secondary · 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.

Group	Value	95% CI
Intervention Group	.11	± 4.4
Usual Care Control Group	.17	± 3.3

Change in Resilience Secondary · 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.

Group	Value	95% CI
Intervention Group	.10	± .38
Usual Care Control Group	-.02	± .44

Participant Global Impression of Change - Functioning Secondary · 8 weeks

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

Group	Value	95% CI
Intervention Group	6.4	± .74
Usual Care Control Group	4.6	± 1.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Two months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group

Serious: 2/25 (8%)

Deaths: 0/25

Usual Care Control Group

Serious: 0/26 (0%)

Deaths: 0/26

Serious adverse events (2 terms)

Reaction	System	Intervention Group	Usual Care Control Group
hospitalization	Musculoskeletal and connective tissue disorders	—	—
hospitalization	Cardiac disorders	—	—

Most-reported serious reactions: hospitalization, hospitalization.

Data from ClinicalTrials.gov NCT04321239 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Community Health Worker-Led Positive Psychology Intervention for African American Older Adults With Chronic Pain.
   Janevic M, Robinson-Lane SG, Courser R, Brines E, et al · · 2022 · cited 16× · PMID 35394525 · DOI 10.1093/geront/gnac010