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

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

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol
Creator	Chan, J Burns, J Day, M Jensen, M Battalio, S Borckardt, J Ciol, M Ehde, D Friedly, J Mendoza, E Thorn, B Ward, L
Source	Elsevier; Medline; PMC
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.
has issue date	2020-04-14(xsd:dateTime)
bibo:doi	10.1016/j.cct.2020.106000
bibo:pmid	32302791
has license	no-cc
sha1sum (hex)	4b5c2c6c245d7705b5fcb1cd2a533b1147140be5
schema:url	https://doi.org/10.1016/j.cct.2020.106000
resource representing a document's title	A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol
has PubMed Central identifier	PMC7195020
has PubMed identifier	32302791
schema:publication	Contemp Clin Trials
resource representing a document's body	covid:4b5c2c6c245d7705b5fcb1cd2a533b1147140be5#body_text
is schema:about of	named entity 'Study protocol' named entity 'randomized trial' named entity 'Mindfulness Meditation' named entity 'visual information' named entity 'SEM' named entity 'Informed consent' named entity 'Actigraph' named entity 'group setting' named entity 'Mindfulness' named entity 'licensed psychologist' named entity 'CBT' named entity 'sample sizes' named entity 'Benjamini-Hochberg procedure' named entity 'treatment programs' named entity 'adverse effects' named entity 'automatic thoughts' named entity 'coping skills' named entity 'videoconference' named entity 'Actigraph' named entity 'actigraphy' named entity '1, 2' named entity 'clinical experience' named entity 'low back pain' named entity 'EMA' named entity 'randomization' named entity 'SEM' named entity 'randomized trial' named entity 'coping techniques' named entity 'chronic pain' named entity 'psychotic thinking' named entity 'videoconferencing' named entity 'analgesic' named entity 'ActiGraph' named entity 'covariate' named entity 'meditation' named entity 'ecological momentary assessment' named entity 'PowerPoint' named entity 'NCCIH' named entity 'ActiGraph' named entity 'adverse events' named entity 'Chronic pain' named entity 'occupational therapist' named entity 'single-blind' named entity 'real world' named entity 'Cognitive Therapy' named entity 'pain treatment' named entity 'randomization' named entity 'thought disorder' named entity 'Actigraphy' named entity 'relapse' named entity 'low back pain' named entity 'actigraphy' named entity 'randomly assigned' named entity 'biostatistician' named entity 'Disability' named entity 'group cohesion' named entity 'treatment allocation' named entity 'covariate' named entity 'headache' named entity 'Sample size' named entity 'catastrophizing' named entity '28 days' named entity 'effect size' named entity 'cognitive process' named entity 'mindfully' named entity 'parsimony' named entity 'clinical trials' named entity '0.80' named entity 'SEM' named entity 'self-report'

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