Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain

NCT ID: NCT06665906

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2025-10-07

Brief Summary

The purpose of this study is to see if patients with chronic pain can improve how they manage their pain and daily function by working with a care manager and by learning pain coping skills from an online teaching tool.

Detailed Description

This study will determine the effects of patient navigator-delivered care coordination to address the major social drivers of health on pain-related outcomes. All participants will have access to web-based cognitive behavior therapy (PainTrainer) - a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. Some participants will also receive phone call visits with patient navigator to coordinate care.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PainTrainer Followed by Social Intervention

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. At Week 12, social intervention will begin. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Group Type: EXPERIMENTAL

Web-Based Cognitive Behavioral Therapy (PainTrainer)

Intervention Type: BEHAVIORAL

Self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Social Intervention

Intervention Type: BEHAVIORAL

At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Social Intervention Followed by PainTrainer

Participants will have social intervention at study entry. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. At week 12, web-based cognitive behavior therapy (PainTrainer) will begin. PainTrainer is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Group Type: EXPERIMENTAL

Web-Based Cognitive Behavioral Therapy (PainTrainer)

Intervention Type: BEHAVIORAL

Self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Social Intervention

Intervention Type: BEHAVIORAL

At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

PainTrainer Only

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Group Type: EXPERIMENTAL

Web-Based Cognitive Behavioral Therapy (PainTrainer)

Intervention Type: BEHAVIORAL

Self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Interventions

Web-Based Cognitive Behavioral Therapy (PainTrainer)

Self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises.

Intervention Type: BEHAVIORAL

Social Intervention

At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with daily pain for 3 months or longer
• Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score >=4
• Primary care provider must be an Atrium provider
• Has at least one social driver of health: Financial insecurity, work and income, housing, food insecurity, safety, health literacy and at least one of the above, lack of social support and at least one of the above

Exclusion Criteria

• Patients who have active cancer
• Cognitive impairment severe enough to preclude participation in a behavioral/lifestyle change program
• Live in a nursing home or inpatient treatment facility
• Unable to read and converse in English
• Those who are already connected to a patient navigator or nurse coordinator or social worker
• Planned elective surgery in the next 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Ang, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00118893

Identifier Type: -

Identifier Source: org_study_id