Status:

COMPLETED

Learning to Apply Mindfulness to Pain

Lead Sponsor:

United States Department of Defense

Conditions:

Chronic Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The long-term goal of this two-phase project is to reduce chronic pain and co-morbid conditions among Veterans, through scalable, non-pharmacologic evidence-based strategies that are "Veteran-Centric,...

Detailed Description

The investigators will conduct a 3-site 3-arm pragmatic clinical trial (N = 750) to test effectiveness of 2 Mindfulness-Based Interventions (MBIs), Mobile+Group LAMP and Mobile LAMP, compared to usual...

Eligibility Criteria

Inclusion

  • Must have qualifying pain diagnoses on at least 2 occasions, at least 90 days apart, within the same pain category, during the previous 2 years
  • Must report having a pain duration of ≥ 6 months (pain chronicity threshold), and a pain severity score of ≥ 4 on the 0-10 Numeric Rating Scale (pain severity threshold).
  • Must have access to a smart phone that meets the requirement of the mobile app software
  • Must be willing and able to download the mobile app on their phone
  • Must have wireless or cellular internet access on a daily basis
  • Must be willing to meet via video conference on the dates and at the time when Mobile+Group LAMP sessions are held, and attend all sessions of the arm to which they are randomized.

Exclusion

  • new diagnosis of schizophrenia, bipolar disorder, major depressive disorder, or other psychosis within the past 18 months; or current active psychotic symptoms, suicidality, severe depression, manic episode, and/or poorly controlled bipolar disorder (as assessed by a medical chart review)
  • currently enrolled in a research study for pain
  • currently enrolled in mindfulness-based stress reduction (MBSR)

Key Trial Info

Start Date :

November 2 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2023

Estimated Enrollment :

811 Patients enrolled

Trial Details

Trial ID

NCT04526158

Start Date

November 2 2020

End Date

December 30 2023

Last Update

November 5 2024

Active Locations (1)

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1

Minnesota Veteran Administration Health Care System

Minneapolis, Minnesota, United States, 55417