Sustained pain reduction through affective self-awareness in fibromyalgia: a randomized controlled trial

Abstract

Background and objective: Affect and how it is regulated plays a role in pain perception, maintenance of pain, and its resolution. This randomized, controlled trial evaluated an innovative affective self-awareness (ASA) intervention, which was designed to reduce pain and improve functioning in individuals with fibromyalgia.

Participants and methods: Forty-five women with fibromyalgia were randomized to a manualized ASA intervention (n = 24) or wait-list control (n = 21). The intervention began with a one-time physician consultation, followed by 3 weekly, 2-h group sessions based upon a mind-body model of pain. Sessions focused on structured written emotional disclosure and emotional awareness exercises. Outcomes in both conditions were measured by a blinded assessor at baseline, post-intervention, and 6-month follow-up.

Measures: The primary outcome was pain severity (Brief Pain Inventory); secondary outcomes included tender-point threshold and physical function (SF-36 Physical Component Summary). Intent-to-treat analyses compared groups on outcomes using analysis of covariance and on the proportion of patients achieving ≥ 30% and ≥ 50% pain reduction at 6 months.

Results: Adjusting for baseline scores, the intervention group had significantly lower pain severity (p < 0.001), higher self-reported physical function (p < 0.001), and higher tender-point threshold (p = 0.02) at 6 months compared to the control group. From baseline to 6 months, 45.8% of the ASA intervention group had ≥ 30% reduction in pain severity, compared to none of the controls (p < 0.001).

Conclusions: The affective self-awareness intervention improved pain, tenderness, and self-reported physical function for at least 6 months in women with fibromyalgia compared to wait-list control. This study suggests the value of interventions targeting emotional processes in fibromyalgia, although further studies should evaluate the efficacy of this intervention relative to active controls.

Trial registration: ClinicalTrials.gov NCT00437411.

Figures

Figure 1

Subject flow diagram.