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

Wake Forest University (WFU)

Status: Completed

Conditions: Chronic Musculoskeletal Pain

Treatments: Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03927846

UL1TR001420 (U.S. NIH Grant/Contract)

IRB00056912

Details and patient eligibility

About

To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Telephone Contact (Nurse)

Active Comparator group

Description:

6 regular telephone contacts by nurses who will use a motivational interviewing technique

Treatment:

Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy

E-mail contact

Active Comparator group

Description:

6 computer generated email reminders (control arm) over an 8-week period.

Treatment:

Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy