SMART Stepped Care Management for Low Back Pain in the Military Health System

Summary

This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo a subsequent sequential randomization. This will be Phase II of the study intervention. Patients in Phase II will be randomized to receive 1 of 2 treatments (addition of physical therapy or Move 2 Health, whichever one they did not receive OR the MORE Mindfulness intervention). Patients will be followed for 1 year after enrollment.

Conditions

• Low Back Pain
• Chronic Pain
• Military Personnel
• Veterans

Interventions

BEHAVIORAL

Physical Therapy

Physical therapy will be delivered using a guideline-concordant approach based off the Department of Defense -Veterans Affairs Low Back Pain Guidelines, focusing on risk-stratified care deliver (using the STarT Back tool as an adjunct).

BEHAVIORAL

Move 2 Health (M2H)

Participants will receive education for self-management (video and written materials) to introduce the key domains of holistic health in the Move to Health (M2H) model and their relationship to chronic LBP. Next, the participant will complete a Personal Health Inventory. The Inventory will be reviewed by the health coach and patient in order to identify specific domains for priority based on patient preference: 1. Sleep 2. Physical Activity 3. Nutrition 4. Intrinsic Well-Being (Personal Development, Spiritual Well-Being, Emotional Well-Being) 5. Extrinsic Well-Being (Family/Social Relationships, Surroundings) Care may range from guided self-management with the researcher to a specialist referral (e.g., sleep specialist, dietician, behavioral health provider, etc.).

BEHAVIORAL

MORE Mindfulness

Throughout the intervention, three core areas are emphasized. Activities include exercises and at-home work for participants to reinforce these core areas. 1. Mindfulness 2. Cognitive reappraisal 3. Savoring of positive experiences

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Madigan Army Medical Center

  collaborator FED

• 59th Medical Wing

  collaborator FED

• Tripler Army Medical Center

  collaborator FED

• Brooke Army Medical Center

  lead FED

Principal Investigators

• Julie M Fritz, PhD · University of Utah

• Daniel I Rhon, PhD · Brooke Army Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-09

Primary Completion

2025-04-30

Completion

2025-07-31

Countries

• United States

Study Locations