Internet-Based Pain Coping Skills Training for Patients With Lupus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

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.
    

Intervention name(s): PainCOACH
Intervention type(s): Behavioral
Intervention description(s): PainCOACH is an eight-week, automated, internet-based training in specific pain coping skills (such as progressive muscle relaxation, pleasant imagery and activity pacing), and guided practice with each skill.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus; Systemic Lupus Erythematosus