Pilot study of an internet-based pain coping skills training program for patients with systemic Lupus Erythematosus

Abstract

Background Patients with Systemic Lupus Erythematosus (SLE) often experience pain and other symptoms that negatively impact quality of life. Interventions that enhance the use of behavioral and cognitive coping strategies may lead to improved outcomes among patients with SLE. Pain coping skills training (PCST) programs have been shown to improve outcomes among patients with other rheumatic conditions, but there have been no trials of PCST among patients with SLE. This study was a preliminary assessment of the feasibility and efficacy of painTRAINER, an automated, internet-based PCST program, among patients with SLE. Methods Participants (n = 60) with SLE from one health care system were randomly assigned with equal allocation to painTRAINER or a wait list control group. PainTRAINER involves 8 modules; participants were instructed to complete one module weekly, along with practice activities for each cognitive or behavioral coping skill. Outcome measures were assessed at baseline and 9-week follow-up, including the Pain Catastrophizing Scale, PROMIS Subscales (Pain Interference, Physical Function, Sleep Disturbance, Anxiety, Depression, Fatigue and Participation), and the LupusPRO questionnaire. Mean changes in outcomes from baseline to follow up and Cohen’s d effect sizes were computed. Results Effect sizes for the painTRAINER group (relative to the wait list group) were small, with changes being greatest for the PROMIS Depression score (d = − 0.32). Among those randomized to the painTRAINER group, 50% accessed the program (“painTRAINER users”). Most of those who did not access the program stated that they did not receive instructions via email. Effect sizes for “painTRAINER users” (relative to wait list) were larger than for the whole painTRAINER group: Pain Catastrophizing d = − 0.60, PROMIS Pain Interference d = − 0.3., PROMIS Depression d = − 0.44, LupusPRO Health-Related Quality of Life d = 0.30. Conclusions PainTRAINER users reported meaningful improvements in multiple physical and psychological outcomes, supporting the potential of PCST programs to benefit individuals with SLE. However, strategies are needed to improve engagement with the program and tailor content to comprehensively address key SLE symptoms and challenges. Trial registration NCT03933839, May 1, 2019.

EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis

“…Furthermore, an RCT that investigated web-based patient education and counselling14 (LoE: 3; CA: weak) and a quasi-experimental study that examined an educational programme for enhancing self-management in patients with SLE71 (LoE: 3; CA: intermediate) found these interventions to be efficacious in improving self-efficacy. A pilot RCT that investigated an internet-based coping skill training programme in patients with SLE revealed benefit in HRQoL72 (LoE: 3; CA: weak), as did a qualitative study of multidisciplinary patient education52 (LoE: 4; CA: robust).…”

Patient-Reported Outcomes for Quality of Life in SLE: Essential in Clinical Trials and Ready for Routine Care

“…This updated version demonstrates acceptable face, content, convergent, discriminant and criterion validity with acceptable internal consistency and reliability in all domains, except procreation and coping. LupusPRO has only been used in two clinical trials to date [51,52]. One examined the efficacy of an online training program focused on development of pain-coping skills (PainTRAINER) in SLE Patients and reported meaningful improvements in LupusPRO HRQoL scores in patients who received the intervention compared to those in the wait-list control group at 9 weeks [51].…”

“…LupusPRO has only been used in two clinical trials to date [51,52]. One examined the efficacy of an online training program focused on development of pain-coping skills (PainTRAINER) in SLE Patients and reported meaningful improvements in LupusPRO HRQoL scores in patients who received the intervention compared to those in the wait-list control group at 9 weeks [51]. The other trial demonstrated significant improvements in LupusPRO body image (BI) scores in patients with cutaneous involvement who received a novel BI intervention that used a cognitive-based therapy approach compared to those who did not.…”

“…One of the advantages of PROMIS is that it encompasses a wide variety of domains, despite placing a reduced burden on the patient. As such, PROMIS has been increasingly used in studies to investigate a range of SLE symptoms including pain [51], fatigue [100,101], depression [102], quality of life [103], cognitive impairment [104] and sleep quality [105]. Most notably, some of these symptoms such as cognitive impairment and sleep resonate strongly with SLE patients yet are known to be content gaps in other generic questionnaires [106].…”

Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

“…LupusQoL has been used in three drug-related RCTs, however the collected data were used in PRO exploratory analyses [ 22 , 23 ]. LupusPRO has not been used in RCTs, only pilot studies of health interventions [ 24 , 25 ].…”