Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Web-based Pain Self-Management: Nurse-Guided

Conditions
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Chronic Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone Contact (Nurse)<br>6 regular telephone contacts by nurses who will use a motivational interviewing technique | Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy<br>* nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.<br>|
| Active Comparator: E-mail contact<br>6 computer generated email reminders (control arm) over an 8-week period. | Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy<br>* nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome | Up to Week 16 | 
| PROMIS Pain Interference | 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. | Up to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completed Phone Calls | The number of completed phone calls by the nurse will be recorded. | Up to Week 16 | 
| Completed Learning Modules Per Treatment Arm | The number of completed learning modules per treatment arm will be recorded. | Week 16 |