Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
- Conditions
- Chronic Musculoskeletal Pain
- Registration Number
- NCT03927846
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
- To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints. 
- Detailed Description
- The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting. Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique. The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible. If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. Wake Baptist may also develop its own web-based CBT for commercial use. 
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
- at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
- at least 18 years of age;
- reliable phone (landline or cell), and
- have home computer with reliable internet access.
- planned elective surgery during the study period;
- very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
- ongoing unresolved disability claims;
- inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
- cancer-related musculoskeletal pain;
- history of bipolar disorder or schizophrenia; and
- takes daily opioid for more than one year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
- Name - Time - Method - PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity - Up to Week 16 - Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome - PROMIS Pain Interference - Up to Week 16 - PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population. 
- Secondary Outcome Measures
- Name - Time - Method - Completed Learning Modules Per Treatment Arm - Week 16 - The number of completed learning modules per treatment arm will be recorded. - Completed Phone Calls - Up to Week 16 - The number of completed phone calls by the nurse will be recorded. 
Trial Locations
- Locations (1)
- Wake Forest Baptist Health 🇺🇸- Winston-Salem, North Carolina, United States Wake Forest Baptist Health🇺🇸Winston-Salem, North Carolina, United States
