Learning to Apply Mindfulness to Pain

NCT04526158 | Completed Results

• 1 other identifier: #NH170001
• Study Type: interventional
• Target: 811
• Locations: 1 country
• Sites: 1

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," designed to optimize engagement, adherence and sustainability, and are deliverable to large numbers of Veterans.

Conditions

Chronic Pain

Keywords

Mindfulness; Veteran; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in the Brief Pain Inventory (BPI) Interference Score From Baseline, Over the 12-month Follow-up Period.

  Change in the Brief Pain Inventory (BPI) interference score. Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning. Change in the outcome measure operationalized as the weighted average of all of the time points during follow-up, adjusting for the baseline value prior to randomization.

  Weighted average over 10 weeks, 6 months, and 12 months.

Secondary Outcomes (10)

• Change in the Brief Pain Inventory (BPI) Intensity Score From Baseline, Over the 12-month Follow-up Period.

  Weighted average over 10 weeks, 6 months, and 12 months.

• Change in Physical Functioning Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Physical Function

  Weighted average over 10 weeks, 6 months, and 12 months.

• Change in Anxiety Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Anxiety

  Weighted average over 10 weeks, 6 months, and 12 months.

• Change in Fatigue Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Fatigue

  Weighted average over 10 weeks, 6 months, and 12 months.

• Change in Sleep Disturbance Over the 12-month Follow-up Period Assessed by Mean Score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v.2.0 Measure of Sleep Disturbance

  Weighted average over 10 weeks, 6 months, and 12 months.

Study Arms (3)

Mobile+Group LAMP Mindfulness-Based Intervention

EXPERIMENTAL

8 weekly, synchronous interactive online group sessions; access to mobile app and a study website, with an accompanying workbook.

Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention

Mobile LAMP Mindfulness-Based Intervention

EXPERIMENTAL

8 weekly asynchronous sessions, delivered on mobile app and study website, with an accompanying workbook; 3 engagement calls at the middle, beginning and end of the program.

Behavioral: Mobile LAMP Mindfulness-Based Intervention

Usual Care

NO INTERVENTION

Engagement in usual care for 12 months as participants normally would. After the entire follow-up period is complete (12 months), participants in the usual care arm are given access to the Mobile LAMP materials MBI training on the app and study website, and the accompanying workbook.

Interventions

Mobile+Group LAMP Mindfulness-Based Intervention BEHAVIORAL

The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of eight 90-minute weekly group sessions, delivered via secure video-conferencing. The first session is preceded by a 90-minute technical session introducing the video-conference system and other logistics. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to a mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions, and the accompanying workbook.

Also known as: Mobile+Group LAMP

Mobile+Group LAMP Mindfulness-Based Intervention

Mobile LAMP Mindfulness-Based Intervention BEHAVIORAL

The Mobile LAMP MBI consists of 8 self-paced, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website, with an accompanying workbook. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own (the same content used in Mobile+Group LAMP). Participants also participate in 3 engagement phone calls with a facilitator. The 1st call (45-60 minutes), held at the beginning of the program, includes technical and logistical information on engaging with mobile app, website, and workbook; and discussion of goals, challenges and plans for practice. The 2nd (middle of program) and 3rd call (end of program) are 25-45 minutes long and address technical/logistical issues and discussion of goals, progress, plans for practice and strategies to address challenges.

Also known as: Mobile LAMP

Mobile LAMP Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• United States Department of Defense: lead

Study Sites (1)

Minnesota Veteran Administration Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (5)

• Burgess DJ, Evans R, Allen KD, Bangerter A, Bronfort G, Cross LJ, Ferguson JE, Haley A, Hagel Campbell EM, Mahaffey MR, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S29-S36. doi: 10.1093/pm/pnaa337.

  PMID: 33313730 BACKGROUND

• Burgess DJ, Calvert C, Hagel Campbell EM, Allen KD, Bangerter A, Behrens K, Branson M, Bronfort G, Cross LJS, Evans R, Ferguson JE, Friedman JK, Haley AC, Leininger B, Mahaffey M, Matthias MS, Meis LA, Polusny MA, Serpa JG, Taylor SL, Taylor BC. Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1163-1173. doi: 10.1001/jamainternmed.2024.3940.

  PMID: 39158851 BACKGROUND

• Burgess DJ, Calvert C, Bangerter A, Branson M, Cross LJS, Evans R, Ferguson JE, Friedman JK, Hagel Campbell EM, Haley AC, Hennessy S, Kraft C, Mahaffey M, Matthias MS, Meis LA, Serpa JG, Taylor SL, Taylor BC. Do mindfulness interventions cause harm? Findings from the Learning to Apply Mindfulness to Pain (LAMP) Pragmatic Clinical Trial. Pain Med. 2024 Nov 1;25(Supplement_1):S68-S76. doi: 10.1093/pm/pnae056.

  PMID: 39514882 DERIVED

• Ferguson JE, Hagel Campbell E, Bangerter A, Cross LJS, Allen KD, Behrens K, Branson M, Calvert C, Friedman JK, Hennessy S, Meis LA, Taylor BC, Burgess DJ. Email recruitment for chronic pain clinical trials: results from the LAMP trial. Trials. 2024 Jul 19;25(1):491. doi: 10.1186/s13063-024-08301-8.

  PMID: 39030622 DERIVED

• Burgess DJ, Hagel Campbell EM, Branson M, Calvert C, Evans R, Allen KD, Bangerter A, Cross LJS, Driscoll MA, Hennessy S, Ferguson JE, Friedman JK, Matthias MS, Meis LA, Polusny MA, Taylor SL, Taylor BC. Exploring Gender Differences in Veterans in a Secondary Analysis of a Randomized Controlled Trial of Mindfulness for Chronic Pain. Womens Health Rep (New Rochelle). 2024 Feb 12;5(1):82-92. doi: 10.1089/whr.2023.0086. eCollection 2024.

  PMID: 38404673 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Diana Burgess
• Organization: Minneapolis VAMC

diana.burgess@va.gov

612-567-1591

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The randomization list will be concealed from the research team within the tracking portal, so team members will not know the next study assignment. Permuted blocks will be used to aid in the concealment of treatment assignment while ensuring balance in treatment arms across time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three arm parallel assignment design

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 25, 2020
• Study Start: November 2, 2020
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)