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

Not Applicable

Completed

• Conditions: Chronic Musculoskeletal Pain
• Interventions: Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy

• 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.

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Study Start: 2019-07-17
• Primary Completion: 2021-01-18
• Study Completion: 2021-01-18
• Status Verified: 2021-02
• Results First Submitted: 2021-05-05
• Results First Submitted QC: 2021-06-24
• Results First Posted: 2021-07-15
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone Contact (Nurse)	Nurse-guided Web-based Cognitive Behavioral Therapy	6 regular telephone contacts by nurses who will use a motivational interviewing technique
E-mail contact	Nurse-guided Web-based Cognitive Behavioral Therapy	6 computer generated email reminders (control arm) over an 8-week period.

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