A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol

M A Day, D M Ehde, J Burns, L C Ward, J L Friedly, B E Thorn, M A Ciol, E Mendoza, J F Chan, S Battalio, J Borckardt, M P Jensen, M A Day, D M Ehde, J Burns, L C Ward, J L Friedly, B E Thorn, M A Ciol, E Mendoza, J F Chan, S Battalio, J Borckardt, M P Jensen

Abstract

This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762). This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.

Keywords: Activation skills; Chronic low back pain; Chronic pain; Cognitive therapy; Mechanisms; Mindfulness meditation.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Fig. 1
Fig. 1
Study design and trial flowchart. *Based on the Tx session 1 date of the earliest group.
Fig. 2
Fig. 2
EMA data collection and data time points used in statistical analyses. Note: The specific day counts are approximate and might slightly vary in the instance of extenuating circumstances for a given cohort.
Fig. 3
Fig. 3
Initial model testing the mechanism role of pain catastrophizing during treatment.

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