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

Contemporary clinical trials
June 1, 2020
M A Day et al. (12 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the mechanisms of mindfulness meditation (MM) in reducing pain interference and compare its effectiveness to cognitive therapy (CT) and activation skills (AS) in individuals with chronic pain.

Results Summary

The study will assess whether early-treatment changes in cognitive content, cognitive process, or activity level predict late-treatment improvement in pain interference, but results are not yet available as the study is ongoing. The findings will help determine the temporal sequence of mediation effects and guide future psychosocial interventions for chronic pain.

Population

300 individuals with chronic pain, including those with low back pain as a primary or secondary condition.

Effective Dosage

Eight, 1.5-hour telehealth group sessions.

Duration

4-week treatment period.

Interactions

None mentioned

Extracted Claims (18)
InterventionDirectionEndpointPopulationDosageImpactClaim #
cognitive therapy (CT)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the mechanisms
#1
mindfulness meditation (MM)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the mechanisms
#2
activation skills (AS)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the mechanisms
#3
cognitive therapy (CT)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the extent to which late-treatment improvement is predicted by early-treatment changes
#4
mindfulness meditation (MM)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the extent to which late-treatment improvement is predicted by early-treatment changes
#5
activation skills (AS)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the extent to which late-treatment improvement is predicted by early-treatment changes
#6
cognitive therapy (CT)
neutral
relapse mechanisms
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the shared versus specific role of these mechanisms
#7
mindfulness meditation (MM)
neutral
relapse mechanisms
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the shared versus specific role of these mechanisms
#8
activation skills (AS)
neutral
relapse mechanisms
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will evaluate the shared versus specific role of these mechanisms
#9
cognitive therapy (CT)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the temporal sequence of lagged mediation effects to evaluate rates of change
#10
mindfulness meditation (MM)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the temporal sequence of lagged mediation effects to evaluate rates of change
#11
activation skills (AS)
neutral
pain interference
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will determine the temporal sequence of lagged mediation effects to evaluate rates of change
#12
cognitive therapy (CT)
neutral
psychosocial chronic pain interventions
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will provide an empirical basis for enhancing and streamlining
#13
mindfulness meditation (MM)
neutral
psychosocial chronic pain interventions
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will provide an empirical basis for enhancing and streamlining
#14
activation skills (AS)
neutral
psychosocial chronic pain interventions
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will provide an empirical basis for enhancing and streamlining
#15
cognitive therapy (CT)
decrease
relapse risk
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will guide future efforts towards optimizing maintenance of gains to effectively reduce
#16
mindfulness meditation (MM)
decrease
relapse risk
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will guide future efforts towards optimizing maintenance of gains to effectively reduce
#17
activation skills (AS)
decrease
relapse risk
300 individuals with chronic pain (with low back pain as a primary or secondary condition)
-
will guide future efforts towards optimizing maintenance of gains to effectively reduce
#18
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.

Medical Subject Headings (MeSH)
ActigraphyAffectChronic PainCognitive Behavioral TherapyExercise TherapyFemaleHumansLow Back PainMaleMental HealthMindfulnessMotivational InterviewingPain MeasurementPhysical Functional PerformanceResearch DesignSelf EfficacySeverity of Illness IndexSingle-Blind MethodTelemedicineRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations11
Citations/Year2.2
Relative Citation Ratio1.13
NIH Percentile54.6%
Research Impact Scores
APT Score0.75
Weight Score2.42
Normalized Score0.67
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