Nurse Care Management for Chronic Pain

(AIM-CP Trial)

Overseen By Dennis Ang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Cancer pain, Major surgery, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-medication treatments for chronic pain, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Nurse Care Management for Chronic Pain?

Research shows that cognitive-behavioral therapy (CBT), a key part of this treatment, is effective in improving pain and related issues for people with chronic pain. Multiple studies have found CBT beneficial for various chronic pain conditions, including in older adults, and it has been successfully adapted for different delivery methods. ^{1 2 3 4 5}

Is cognitive-behavioral therapy (CBT) safe for treating chronic pain?

Cognitive-behavioral therapy (CBT) is generally considered safe for treating chronic pain, with studies showing it can be beneficial for various populations, including children and older adults. ^{1 2 3 6 7}

How is the treatment Cognitive Behavioral Therapy (CBT) unique for managing chronic pain?

Cognitive Behavioral Therapy (CBT) is unique for managing chronic pain because it focuses on changing the way patients think and behave in relation to their pain, rather than just addressing the physical symptoms. It can be delivered in various innovative formats, such as online or over the phone, making it accessible to more people, and it has been tailored to benefit special populations like children and older adults. ^{1 2 3 5 6}

What is the purpose of this trial?

Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.

Research Team

Sebastian Tong, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults living in rural areas who suffer from chronic pain. Participants should not have access to non-medication-based treatments and must be willing to engage with a nurse-led care program that includes cognitive therapy and exercise.

Inclusion Criteria

I have been experiencing pain for at least 3 months.

Current primary care patient with one care visit in the last year

Live in a rural area

Exclusion Criteria

I have received training or education for managing pain in the last 6 months.

Living in a nursing home or inpatient treatment facility

Moderate or severe cognitive impairment (documented diagnosis or score 12 or lower on the telephone Montreal Cognitive Assessment)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants work with a care manager for 6 months, including monthly virtual appointments, 6-10 sessions of Cognitive Behavioral Therapy (CBT), and referrals to the Enhance Fitness program

6 months

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Care Coordination
• Cognitive Behavioral Therapy (CBT)
• Enhance Fitness

Trial Overview The study tests a Nurse Care Management model which involves coordinating care, providing Cognitive Behavioral Therapy (CBT), and referring patients to an exercise program designed for those with chronic pain, all delivered remotely.

Participant Groups

Group I: Care Manager Arm Experimental Treatment 3 Interventions

In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help refer patients to Enhance Fitness, an online community program that allows users to access instructor-led group exercise classes from home.

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

A study involving 14 patients with chronic pain explored their experiences with a high-intensity cognitive-behavioral therapy (CBT) protocol, which included various innovative techniques like tactile attention-shift training and video feedback.

Patients reported varying levels of helpfulness from different CBT components, with memory work being beneficial for nine patients and visual feedback being very helpful for six, indicating that personalized approaches in CBT may enhance treatment outcomes for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. Kutsuzawa, K., Taguchi, K., Shimizu, E.[2022]

A systematic review of 19 studies on cognitive behavioral therapy (CBT) for chronic pain found that psychological factors like anxiety, depression, and negative thoughts about pain significantly influence treatment outcomes, with medium to large effect sizes.

Sociodemographic factors had only small effects on CBT outcomes and were not consistently replicable, highlighting the need for more research to identify reliable predictors and improve the consistency of study designs in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. Forden, G., Ronaghan, S., Williams, P., et al.[2023]

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

A single-session videoconference intervention called empowered relief (ER) significantly reduced pain catastrophizing and improved pain-related outcomes in adults with chronic pain, showing substantial clinical importance at 3 months post-treatment.

Participants reported high satisfaction and engagement with the ER program, suggesting that web-based delivery can enhance accessibility and address barriers to in-person pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. Ziadni, MS., Gonzalez-Castro, L., Anderson, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Management of chronic pain through pain management programmes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. [2022]