Mindful Action for Pain

Chronic pain, defined as persistent or episodic pain that does not resolve with treatment,
affects up to 50% of Veterans, costs the nation between $560 and $635 billion dollars
annually, and is associated with high rates of disability and low quality of life. According
to the Veterans Health Administration (VHA), the goal of pain treatment is to improve
physical and psychosocial functioning, emphasizing non-pharmacological approaches, such as
psychosocial interventions, to target psychosocial factors that maintain disability.
Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive
Behavioral Therapy (CBT), does not reliably produce meaningful increases in function.

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 CBT, but still 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 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 RCT (n = 86) of MAP vs. 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.

Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).

Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP
(Phase 2).

Hypothesis 1: MAP and CBT-CP will be feasible to deliver, as evidenced by attainment of
recruitment goals, retention rates > 80%, and high credibility and expectancy ratings.

Aim 3: Estimate the preliminary impact of MAP and CBT-CP to determine if a future efficacy
trial is warranted.

Examine changes in pain interference (a proxy for functional improvement and one of the most
commonly measured outcomes in psychosocial intervention trials of chronic pain), pain
acceptance, trait mindfulness, and pain catastrophizing, as well as patient satisfaction
ratings, as indicators that MAP may be worthy of investigation in a future large-scale trial.

Exploratory Aim 1: Explore the relationship between meditation adherence and treatment
outcomes.

There is growing evidence for a dose-response relationship between meditation practice and
positive outcomes. Therefore, strategies to increase meditation adherence will be optimized
(Phase 1) and the relationship between adherence as measured via daily diaries and outcomes
will be assessed (Phase 2).

Exploratory Aim 2: Explore objective measures of physical activity at baseline and
post-intervention as a potential future index of functional outcomes.