A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol.
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
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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.