CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 126 enrolled
Drug / intervention
Mindful Action for Pain +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03800654
NCT03800654N/ACompleted

Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function

VA Office of Research and Development·interventional·Posted Jan 11, 2019·Updated Feb 17, 2026

In Brief

A clinical study evaluating Mindful Action for Pain and Cognitive Behavioral Therapy for Chronic Pain for Chronic Pain. Completed, enrolled 126 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 11, 2019
Enrollment StartAug 28, 2019
Primary CompletionSep 29, 2023
Study CompletionMar 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.5 years ago

Interventions

Mindful Action for Painbehavioral

MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.

Cognitive Behavioral Therapy for Chronic Painbehavioral

CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.