Learning to Apply Mindfulness to Pain

Chronic Pain Clinical Trial

— LAMP  

Official title:

Testing Two Scalable, Veteran-centric Mindfulness-based Interventions for Chronic Musculoskeletal Pain: A Pragmatic, Multisite Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526158
• Other study ID #: #NH170001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: United States Department of Defense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 practice. Effectiveness will be assessed by pain functioning over the 12-month follow-up period using the Brief Pain Inventory (BPI) interference score. The investigators will test the following primary hypotheses: (1) Mobile LAMP will be more effective at improving chronic pain (as measured by change in the BPI interference score over the 12-month follow-up period) compared to usual practice, (2) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference score over the 12-month follow-up period) compared to usual practice, and (3) Mobile+Group LAMP will be more effective at improving chronic pain (as measured by BPI interference change over the 12-month follow-up period) compared to Mobile LAMP without the group component. The investigators will test the following secondary hypotheses: (1) Comparison of intervention group with secondary outcomes listed below, and (2) primary and secondary hypotheses comparisons will be confirmed in gender-specific strata. The primary outcome will be measured as change in BPI interference score over the 12-month follow-up period. Secondary outcomes will include patient-reported measures related to pain, comorbid mental health conditions and function, expected mediators of treatment effects, patient satisfaction, and adverse effects and measures captured in electronic health records. These outcomes will be assessed at 10 weeks, 6 months and 12 months. Implementation data will be collected and described, using the guided Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 811
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mobile+Group LAMP Mindfulness-Based Intervention
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.
• Mobile LAMP Mindfulness-Based Intervention
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.

Locations

Country	Name	City	State
United States	Minnesota Veteran Administration Health Care System	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Brief Pain Inventory (BPI) interference score from baseline, over the 12-month follow-up period.	Minimum value: 0. Maximum value: 10. Higher scores indicate worse functioning.	Assessed at baseline, 10 weeks, 6 months, and 12 months, to capture short-term, mid-term, and long-term effects
Secondary	Change in the Brief Pain Inventory (BPI) intensity score from baseline, over the 12-month follow-up period.	Minimum value: 0. Maximum value: 10. Higher scores indicate more severe pain.	Assessed at baseline, 10 weeks, 6 months, and 12 months, to capture short-term, mid-term, and long-term effects
Secondary	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	Minimum value: 1. Maximum value: 5. Lower scores indicate worse physical functioning	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	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	Minimum value: 1. Maximum value: 5. Higher scores indicate worse anxiety	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	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	Minimum value: 1. Maximum value:5. Higher scores indicate worse fatigue	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	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	Minimum value: 1. Maximum value: 5. Higher scores indicate worse sleep disturbance	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	Change in participation in social roles and activities over the 12-month follow-up period assessed by mean score on the PROMIS-29 Profile v.2.0 measure of participation in social roles and activities	Minimum value: 1. Maximum value: 5. Lower scores indicate greater participation in social roles and activities	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	Change in depression over the 12-month follow-up period assessed by score on the eight-item Patient Health Questionnaire depression scale (PHQ8)	Minimum value: 0. Maximum value: 24. Higher scores indicate greater depression	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	Change in Post Traumatic Stress Disorder (PTSD), over the 12-month follow-up period, assessed by participants' scores on the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - 5 (PCL-5)	Minimum value: 0. Maximum value: 80. Higher scores indicate greater PTSD	Assessed at baseline, 10 weeks, 6 months, and 12 months
Secondary	Mean global improvement of pain score, over the 12-month follow-up period	Global impression of change scale from "much better" to "much worse"	Assessed at 10 weeks, 6 months, and 12 months
Secondary	BPI Interference Score Responder Analysis	Change in Brief Pain Inventory (BPI) interference score over the 12-month follow-up period. Number with 30% improvement in BPI inference score to capture short-term, mid-term, and long-term effects.	Assessed at 10 weeks, 6 months, and 12 months.