Clinical trial NCT03933839: Internet-Based Pain Coping Skills Training for Patients With Lupus
Official title: Internet-Based Pain Coping Skills Training (PainCOACH) for Patients With Lupus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus
Systemic Lupus Erythematosus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline to 9 weeks in PROMIS Pain Interference Score
timeFrame: Baseline and 9 weeks
Secondary outcomes:
measure: Change from Baseline to 9 weeks in PROMIS-29 Score
timeFrame: Baseline and 9 weeks
measure: Change from Baseline to 9 weeks in Coping Strategies Questionnaire (CSQ) Score
timeFrame: Baseline and 9 weeks
measure: Change from Baseline to 9 weeks in LupusPRO Score
timeFrame: Baseline and 9 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen KD, Beauchamp T, Rini C, Keefe FJ, Bennell KL, Cleveland RJ, Grimm K, Huffman K, Hu DG, Santana A, Saxena Beem S, Walker J, Sheikh SZ. Pilot study of an internet-based pain coping skills training program for patients with systemic Lupus Erythematosus. BMC Rheumatol. 2021 Jun 17;5(1):20. doi: 10.1186/s41927-021-00191-6.