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Clinical Trials/NCT03933839
NCT03933839CompletedNot Applicable

Internet-Based Pain Coping Skills Training (PainCOACH) for Patients With Lupus

University of North Carolina, Chapel Hill2 sites in 1 country60 target enrollmentStarted: May 20, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Change from Baseline to 9 weeks in PROMIS Pain Interference Score

Study Overview

Brief Summary

This is a pilot study of an automated, internet-based pain coping skills training (PCST) program, PainCOACH.

Detailed Description

Background and Significance: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that impacts multiple organ systems. SLE results in a variety of challenging symptoms, including flare-ups and periods of remission that are unpredictable, and it is a complex disease to manage clinically. Because of these factors, SLE often has a major impact on patients' quality of life. Notably, SLE is often associated with pain, fatigue, emotional symptoms like anxiety and depression, and disability. Because of the relatively young average age of SLE onset, many patients must navigate these challenges while maintaining work and / or caring for young children.

Prior studies show that greater use of adaptive coping strategies and greater self-efficacy for coping with SLE-related symptoms are associated with better physical and psychological outcomes. Conversely, maladaptive coping behaviors, particularly pain catastrophizing (e.g., focusing on and exaggerating the threat of pain and negatively evaluating one's ability to deal with pain), are associated with poorer SLE outcomes. Importantly, many studies in other rheumatic conditions have shown that pain coping skills training (PCST) programs can improve coping patterns, as well as physical and psychological health outcomes. However, there have been no trials of PCST among individuals with SLE, who face a unique set of disease-related challenges and are overall younger than patients with many other rheumatic conditions. Delivery of PCST programs to patients with SLE could have a tremendous impact on outcomes and quality of life, but this evidence base needs to be established, including adaptations of current PCST programs that may be important specifically for patients with SLE. Therefore, the objective of this project is to conduct a pilot study of an automated, internet-based PCST program, PainCOACH, that has been shown to improve multiple key outcomes among patients with osteoarthritis

Study Aims: This project has three specific aims: 1) Evaluate the feasibility and acceptability of PainCOACH among patients with SLE. 2) Obtain a preliminary assessment of the efficacy of PainCOACH (relative to a wait list control group) for improving pain interference and other key outcomes among patients with SLE 3) Determine appropriate adaptations to PainCOACH for patients with SLE.

Study Description: Investigators will conduct a randomized pilot study, with N=60 patients age >= 18 years with physician diagnosis of systemic lupus erythematosus (SLE), equally allocated to PainCOACH and a wait list control group that will be offered PainCOACH after completion of the 9 week follow-up assessment. This design will allow a between-group comparison as well as collection of acceptability data from the control group following their completion of PainCOACH. Outcomes will be assessed at baseline and at about 9 week follow-up as PainCOACH is designed for delivery over 8 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • physician diagnosis of Systemic lupus erythematosus (SLE)

Exclusion Criteria

  • significant memory loss
  • active psychosis or substance abuse
  • neuropsychiatric SLE
  • severe hearing impairment
  • inability to speak English
  • pregnant or planning to become pregnant in the next 3 months
  • current participation in another SLE-related trial

Outcomes

Primary Outcomes

Change from Baseline to 9 weeks in PROMIS Pain Interference Score

Time Frame: Baseline and 9 weeks

PROMIS Pain Interference (Short Form 6a) includes 6 items assessing self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities rated on a Likert scale of 1 (not at all) to 5 (very much). Scores are converted to t-scores and higher scores indicate greater pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.

Secondary Outcomes

  • Change from Baseline to 9 weeks in PROMIS-29 Score(Baseline and 9 weeks)
  • Change from Baseline to 9 weeks in Coping Strategies Questionnaire (CSQ) Score(Baseline and 9 weeks)
  • Change from Baseline to 9 weeks in LupusPRO Score(Baseline and 9 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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