Mindful Action for Pain

NCT03800654 | Completed Results DMC

• 2 other identifiers: D2807-WRX002807
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Psychological Flexibility; Mindfulness Meditation

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Pain Interference Subscale Change

  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. Scores are averaged with a range from 0 to 10. Higher scores indicate higher levels of pain interference (i.e., worse outcome).

  Baseline and week 9

Secondary Outcomes (3)

• Chronic Pain Acceptance Questionnaire (CPAQ)

  Baseline and week 9

• Mindfulness Attention Awareness Scale (MAAS)

  Baseline and week 9

• Pain Catastrophizing Scale (PCS)

  Baseline and week 9

Other Outcomes (2)

• Meditation Diaries

  Collected daily during the 8-week intervention

• Actigraphy

  Baseline and week 9

Study Arms (2)

Mindful Action for Pain (MAP) Development

OTHER

In the first arm, MAP will be fully developed.

Behavioral: Mindful Action for Pain

MAP vs. CBT-CP

ACTIVE COMPARATOR

In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.

Behavioral: Mindful Action for Pain; Behavioral: Cognitive Behavioral Therapy for Chronic Pain

Interventions

Mindful Action for Pain BEHAVIORAL

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

Also known as: MAP

MAP vs. CBT-CP; Mindful Action for Pain (MAP) Development

Cognitive Behavioral Therapy for Chronic Pain BEHAVIORAL

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.

Also known as: CBT-CP

MAP vs. CBT-CP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Matthew Herbert
• Organization: VA San Diego Healthcare System

Matthew.Herbert2@va.gov

858-642-1411

Study Officials

• Matthew Herbert, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Group Randomized Controlled Trial

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: August 28, 2019
• Primary Completion: September 29, 2023
• Study Completion: March 29, 2024
• Last Updated: February 17, 2026
• Results First Posted: January 31, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Indefinitely
• Access Criteria: February, 2024

Locations

US (1)