Learning to Apply Mindfulness to Pain (LAMP)

United States Department of Defense

Status: Active, not recruiting

Conditions: Chronic Pain

Treatments: Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention; Behavioral: Mobile LAMP Mindfulness-Based Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04526158

#NH170001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 811 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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811 participants in 3 patient groups

Mobile+Group LAMP Mindfulness-Based Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Mobile+Group LAMP Mindfulness-Based Intervention

Mobile LAMP Mindfulness-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile LAMP Mindfulness-Based Intervention

Usual Care

No Intervention group

Description:

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.