Mindful Action for Pain

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning. This career development award (CDA-2) project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot randomized controlled trial (RCT) (n = 86) of MAP vs. cognitive behavioral therapy (CBT) for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

Key facts

Study ID: NCT03800654
Run by: VA Office of Research and Development
People needed: 126
Starts: 2019-08-28
Expected to finish: 2024-03-29
Last updated by the study team: 2026-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Veteran
Diagnosis of a chronic, non-terminal pain condition
Pain most days (> 3 days/week) for at least 6 months
Average pain severity and interference with enjoyment of life and/or general activity rated > 4/10 over the past week

You may not qualify if…

Serious or unstable medical or psychiatric illness
(e.g., unmanaged psychosis, manic episode, or substance abuse within the past year) or psychosocial instability
(e.g., homelessness) that could compromise study participation
Active suicidal ideation or history of suicide attempt within past 3 years
Current participation in group psychotherapy for pain or any type of individual psychotherapy
Changes to professionally delivered pain or mood treatments
(e.g., no discontinuation of a treatment; no increasing the dose of medication) one month preceding the baseline assessment.

Where it is running

VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States

Full record on ClinicalTrials.gov

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