Development of an Internet-based Behavioral Pain Management Intervention

OBJECTIVES: The primary objectives of the proposed study are to: (1) develop an integrative, Internet-based, Veteran-centered behavioral intervention, the Pain EASE program for chronic low back pain (CLBP), and (2) examine preliminary efficacy, usability, and satisfaction of this intervention in a representative sample of Veterans with CLBP. The primary hypothesis states that a clinically meaningful reduction in pain-related functional interference will be observed following ten weeks of exposure to the Pain EASE program relative to baseline. The secondary hypotheses state that clinically meaningful reductions in ratings of average pain intensity on a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale at the ten week post-baseline follow-up assessment interval will be observed, in addition to statistically significant reductions in fatigue, sleep problems, depressive symptoms, and negative mood at the ten week post-baseline assessment. The tertiary hypotheses state that participants will report high levels of interest, site usage, and satisfaction.

RESEARCH DESIGN: A non-randomized pilot study with two phases is proposed to develop and evaluate an internet-based behavioral pain self-management program. Phase I will solely involve qualitative data collection. Repeated quantitative assessments during Phase II will be conducted at baseline and 10-weeks post-baseline.

METHODOLOGY: A 24-month pilot study with two phases is proposed. During Phase I, the Pain EASE program will be developed and feedback from 15 Veterans with CLBP and an Expert Panel of pain management clinicians will be used to modify the program. During Phase II, a pilot feasibility trial of the Pain EASE program with 55 Veterans with CLBP will be conducted. Subjects will be a total of 70 patients receiving care at the VA Connecticut Healthcare System (VACHS) who report chronic low back pain. The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain (i.e., scores of 4 or greater on a 0 [no pain] to 10 [worst pain imaginable]) on a numerical rating scale of pain and indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist. All patients must have access to a computer with an internet connection. Excluded will be patients with life threatening or acute physical illness, current alcohol or substance abuse or dependence, current psychosis, suicidal ideation, dementia, and individuals seeking surgical pain treatment. All participants will continue to receive their usual care from Veterans Health Administration (VHA) providers. During the 10-week therapeutic window, weekly telephone calls from research staff will serve to cue and monitor participants' use of the Internet program. At ten weeks post-baseline, participants will be formally reassessed. Primary and secondary hypotheses involving quantitative data will be analyzed using an intent-to-treat principle and will employ t-tests and non-parametric analogs and regression analyses.