Clinical trial NCT03800654: Mindful Action for Pain
Official title: Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Psychological Flexibility
Mindfulness Meditation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-11
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief Pain Inventory (BPI) Pain Interference Subscale Change
timeFrame: Baseline and week 9
Secondary outcomes:
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: Baseline and week 9
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Baseline and week 9
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and week 9
Other outcomes:
measure: Meditation Diaries
timeFrame: Weekly during treatment (i.e., weeks 1 - 8) and week 9
measure: Actigraphy
timeFrame: Baseline and week 9
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Matthew Herbert, PhD
role: PRINCIPAL_INVESTIGATOR
References: