Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03800654
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2019-01-08
Brief Title:
Mindful Action for Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Mindful Action for Pain An Integrated Approach to Improve Chronic Pain Function
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAP
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 ones 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 eg 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
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
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 ones 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 eg 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
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 ones 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX002807 | OTHER_GRANT | VA RRD | None |