Clinical trial NCT03927846: Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
Official title: Web-based Pain Self-Management: Nurse-Guided
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria: -

1. 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;
2. at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
3. at least 18 years of age;
4. reliable phone (landline or cell), and
5. have home computer with reliable internet access.

Exclusion Criteria:

1. planned elective surgery during the study period;
2. very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
3. ongoing unresolved disability claims;
4. inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
5. cancer-related musculoskeletal pain;
6. history of bipolar disorder or schizophrenia; and
7. takes daily opioid for more than one year.

Primary outcomes:
measure: PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
timeFrame: Up to Week 16
measure: PROMIS Pain Interference
timeFrame: Up to Week 16
Secondary outcomes:
measure: Completed Phone Calls
timeFrame: Up to Week 16
measure: Completed Learning Modules Per Treatment Arm
timeFrame: Week 16
Other outcomes:
measure: Proportion of Subjects With Interest in Pain Self-management
timeFrame: Up to Week 16
measure: Proportion of Patients Who Viewed Educational Video
timeFrame: Up to Week 16
measure: Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.
timeFrame: Up to Week 16
measure: Ratings of Perceived Disruption
timeFrame: Up to Week 16
measure: Uptake Rates
timeFrame: Up to Week 16
measure: Self-report Frequency of Practicing Pain Coping Skills
timeFrame: Up to Week 16
measure: Participant Overall Satisfaction on Web-based CBT Program
timeFrame: Up to Week 16
measure: Nurse's Time
timeFrame: Up to Week 16
measure: Perceived Work Rating
timeFrame: Up to Week 16
measure: Motivational Interviewing Treatment Integrity (MITI) Scale
timeFrame: Up to Week 16
measure: Mean Opioid Daily Dose
timeFrame: Up to Week 16
measure: Non-study Phone Calls
timeFrame: Up to Week 16
measure: New Referrals to Other Musculoskeletal-related Specialties
timeFrame: Up to Week 16
measure: Number of Emergency Room Visits Related to Pain
timeFrame: Up to Week 16
measure: PROMIS Physical Health -Fatigue
timeFrame: Up to Week 16
measure: PROMIS Physical Health - Physical Function
timeFrame: Up to Week 16
measure: PROMIS Physical Health - Sleep-related Impairment
timeFrame: Up to Week 16
measure: PROMIS Physical Health- Pain Behavior
timeFrame: Up to Week 16
measure: PROMIS Social Health
timeFrame: Up to Week 16
measure: Brief Pain Inventory (BPI) Pain Severity
timeFrame: Up to Week 16
measure: BPI Pain Interference
timeFrame: Up to Week 16
measure: Pain Catastrophizing Score (PCS)
timeFrame: Up to Week 16
measure: Global Rating of Change (GRoC)
timeFrame: Up to Week 16
measure: Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Up to Week 16
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Up to Week 16
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Dennis Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: