Staying Positive With Arthritis Study

NCT02223858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-04-03

Study results available
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Summary

Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. According to the biopsychosocial model of pain, there is a need for novel interventions that target psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence from the field of psychology suggests that an intervention designed to develop a positive mindset has the potential to improve pain and functioning and reduce racial disparities in patients with arthritis. Interventions to foster a positive mindset have been developed for clinical patient populations but have not yet been fully tested in patients with arthritis or in Veterans, nor have their effects on racial differences in clinical outcomes been examined. This study will address these gaps by testing the impact of an evidence-based positive activities intervention on pain and functioning in African American and White Veterans with knee arthritis.

Conditions

Interventions

BEHAVIORAL

Positive Activities (PA) Program

6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.

BEHAVIORAL

Attention Control (AC) Program

6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Leslie RM Hausmann, PhD · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-13
Primary Completion
2017-11-09
Completion
2017-11-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223858 on ClinicalTrials.gov