NCT06351774

Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain

An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Ohio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP).

Detailed description

The overall objective is to primarily elucidate differential changes in CLBP patients administered PT or PT+HMI across physical health domains (back disability, pain interference, actigraphy, gait performance). Secondarily, we will elucidate changes in patient-reported physical health outcomes for early non-responders who go on to receive an adaptive intervention that provides augmented treatment pathways. Our central hypothesis is that improvements in disability (primary outcome), i.e., responders to PT and PT+Well will be differentially associated with changes in physical activity levels, gait kinematics, psychological flexibility, and fear-avoidance. We further predict that initial non-responders who progress to augmented care will show improvements in the primary outcomes. We will conduct a two-armed RCT with 20 CLBP participants who will receive PT or PT+HMI and test our hypotheses in 3 specific aims. In Aim 1, we will use patient-reported measures of disability and pain interference to elucidate subjective physical health outcomes. In Aim 2, we will use actigraphy to measure physical activity levels, 3D trunk kinematic measures during gait, and a lifting task to reveal movement-based responders. In Aim 3, we will use patient-reported measures for indices of psychological flexibility and healthy emotionality to elucidate mental health processes that correlate with physical health outcomes.

Conditions

• Back Pain Lower Back Chronic
• Disability Physical

Interventions

Type	Name	Description
BEHAVIORAL	Physical therapy	Physical therapy for the treatment of chronic low back pain, as directed by a licensed Physical Therapist. The Healthy Minds Innovations (HMI) program is an app-based learning platform developed through the University of Wisconsin-Madison Center for Healthy Minds. The HMI app includes foundational meditation practices and short podcast-style lessons based on the science of wellbeing to cultivate mindfulness, positive relationships, and insight into the nature of the self.

Timeline

• Start date: 2022-05-24
• Primary completion: 2024-02-08
• Completion: 2024-03-25
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

1 site across 1 country: United States