Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia

Abstract

Fibromyalgia syndrome (FMS) is a chronic musculoskel- etal condition characterized by widespread pain, impaired physical functioning, and deficits in positive affect (PA). Standard behavioral therapies for FMS focus on reducing negative affect (NA) and yield only modest benefits. We examined the feasibility, acceptability and preliminary effi- cacy of a 6-week, online, PA-enhancing intervention, entitled: Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR). We enrolled participants from one large health system in New York City and ResearchMatch. Ninety-five FMS patients were randomized to LARKSPUR or a neutral emotion reporting arm. Results to date indicate that LARKSPUR is feasible: recruitment (82%), retention (93%); and acceptable: mean satisfaction score on 1-10 scale (9.4, SD=1.2). Planned efficacy analyses will evaluate treatment effects on pain intensity and interference, depressive symp- toms, and stress appraisals. If effective, LARKSPUR will lay the foundation for understanding how behavioral treatments for FMS can be optimized through PA enhancement.

Kenneth Tyler Wilcox

Statistical Consultant

My research interests include integrative data analysis, meta-analysis, topic modeling, Bayesian statistics, multilevel modeling, statistical programming, and psychology.