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Mindful Action for Pain (MAP)

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ClinicalTrials.gov Identifier: NCT03800654
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Mindful Action for Pain Behavioral: Cognitive Behavioral Therapy for Chronic Pain Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group Randomized Controlled Trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Mindful Action for Pain (MAP) Development
In the first arm, MAP will be fully developed.
Behavioral: Mindful Action for Pain
MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
Other Name: MAP

Active Comparator: MAP vs. CBT-CP
In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.
Behavioral: Mindful Action for Pain
MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
Other Name: MAP

Behavioral: Cognitive Behavioral Therapy for Chronic Pain
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.
Other Name: CBT-CP




Primary Outcome Measures :
  1. Brief Pain Inventory (BPI) Pain Interference Subscale Change [ Time Frame: Baseline, weekly during treatment (i.e., weeks 1 - 8), and week 9 ]
    The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Higher scores indicate higher levels of pain interference.


Secondary Outcome Measures :
  1. Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: Baseline and week 9 ]
    The CPAQ consists of 20-items rated on a 0 - 6 scale that measures the degree that patients have adjusted to pain as part of their identity and lifestyle. Higher scores indicate higher levels of pain acceptance.

  2. Five-Factor Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline and week 9 ]
    The FFMQ measure five facets of mindfulness: observing inner experience, describing experience, acting with awareness, non-judging of experience, and non-reactivity to inner experience. The FFMQ consists of 39-items rated on a 1 - 5 scale with higher scores indicating greater mindfulness.

  3. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline and week 9 ]
    The PCS consists of 13 items rated on 0 - 4 scale that measures the degree to which people experience an aversive orientation towards pain. Higher scores indicate higher levels of pain catastrophizing.


Other Outcome Measures:
  1. Meditation diaries [ Time Frame: Weekly during treatment (i.e., weeks 1 - 8) and week 9 ]
    On these diaries, participants report the duration of meditation practice and what kind of practice (e.g., breathing, body scan).

  2. Actigraphy [ Time Frame: Baseline and week 9 ]
    Participants will wear actiwatches for two 7-day periods at baseline and week 9 to measure average physical activity counts.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800654


Contacts
Contact: Gerhard H Schulteis, PhD (858) 642-3657 gerhard.schulteis@va.gov
Contact: Patricia A Franklin, AA BS (858) 552-8585 ext 7441 patricia.franklin2@va.gov

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA Not yet recruiting
San Diego, California, United States, 92161
Contact: Niloofar Afari, PhD    619-400-5016    Niloofar.Afari@va.gov   
Principal Investigator: Matthew Herbert, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Matthew Herbert, PhD VA San Diego Healthcare System, San Diego, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03800654     History of Changes
Other Study ID Numbers: D2807-W
RX002807 ( Other Grant/Funding Number: VA RR&D )
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A data repository will be created upon completion of the study. Data obtained in this study that has scientific value to other qualified researchers will made available upon request. Interested researches will be able to access de-identified data through a Data Use Agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Indefinitely
Access Criteria: February, 2024

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Chronic Pain
Psychological Flexibility
Mindfulness Meditation

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms